McKesson Corp. (MCK) acquires US Oncology for $2.16 Billion

By Andrea: http://nursingoncologyjob.com

McKesson Corporation (MCK), a leading healthcare services and information technology company, and US Oncology, a leading integrated oncology company, recently announced that the two companies have signed a definitive agreement under which McKesson will purchase all outstanding shares of US Oncology for cash. The total transaction, including the assumption of US Oncology's outstanding debt, is valued at approximately $2.16 billion. The combined organization will focus on providing a comprehensive offering of solutions for the oncology industry, one of the fastest-growing segments in healthcare.

The parties are targeting a closing by the end of McKesson's third fiscal quarter, ending December 31, 2010, subject to customary conditions, including all necessary regulatory clearances. Excluding transaction and integration costs, the acquisition is expected to be neutral to McKesson's diluted earnings per share in its current fiscal year, and modestly accretive beginning in McKesson's fiscal year 2012. In connection with the acquisition, it is anticipated that substantially all of US Oncology's debt will be repaid or refinanced, including the Senior Floating Rate PIK Toggle Notes due 2012 issued by US Oncology Holdings, Inc., and the 9.125% Senior Secured Notes due 2017 and 10.75% Senior Subordinated Notes due 2014, both issued by US Oncology, Inc.

The unified organization will bring together the collective capabilities of McKesson and US Oncology to provide oncology customers access to:

• Leading evidence-based medicine offerings that drive continued improvements in clinical outcomes and enable value-based reimbursement;
• Expanded clinical expertise, clinical research and personalized medicine offerings;
• Integrated, efficiency-enabling healthcare information technology, including the iKnowMed(TM) and Lynx^(R) technology platforms, facilitating outcomes measurement, reporting, and advanced product and inventory management;
• Innovative practice-management solutions and consultative capabilities that allow independent community specialists to thrive in a changing healthcare environment; and
• Superior distribution capabilities and supply-chain expertise.

These solutions will help community oncologists improve the care experience for patients and drive business and clinical innovations that address the increasing demand for high-quality, cost-effective, personalized cancer care.

"McKesson is committed to improving the health and vitality of our customers, with the ultimate goal of improving the health of patients," said John H. Hammergren, chairman and chief executive officer, McKesson. "The combination of US Oncology and McKesson will enhance our ability to achieve these goals in one of the most important segments in healthcare. Community oncology practices need strategic support that offers not only technology and distribution solutions, but also value-added clinical and reimbursement management services that enable them to provide the highest-quality, most efficient care to their patients. With this acquisition, McKesson will offer a compelling suite of services and solutions to community oncologists and other partners in the rapidly evolving specialty business."

The combined McKesson Specialty Care Solutions business will be led by Bruce Broussard, chairman and chief executive officer of US Oncology, and will be headquartered in The Woodlands, Texas, with continuing operations in the San Francisco Bay Area and other locations throughout the country. Broussard will report to Paul Julian, executive vice president and group president, McKesson Corporation. McKesson will continue to operate the United Network of US Oncology, including US Oncology's Comprehensive Strategic Alliance offering, US Oncology Research and other services under the US Oncology brand name.

Strategic Acquisition Creates Broader, Deeper Oncology Offering

The unified company will deliver a best-in-class oncology program, clinical tools, guidelines and care pathways that will create a leader in evidence-based medicine backed by a deep team of clinical experts. With approximately 3,000 total physician customers, the new organization's expanded breadth will accelerate investments in integrated systems, process excellence, and clinical programs that will help drive productivity, efficient care delivery, and the best possible care experience for patients.

"With the healthcare marketplace moving rapidly toward reimbursement based on quality and cost-effectiveness, our physician customers need access to deep clinical, operational and information technology capabilities to create integrated networks that continually enhance the quality of care in a cost-efficient manner," said Bruce Broussard. "In joining McKesson, we are building the scale and expertise necessary to empower our customer base to shape the future of healthcare."

"The addition of US Oncology's physician-centric business model and clinical expertise to the McKesson portfolio advances our strategy and significantly strengthens our offering for community oncology and other partners in the specialty segment," said Paul Julian. "McKesson and US Oncology's businesses are highly complementary, providing our collective customers access to more services and solutions that will enhance their ability to deliver advanced cancer care."

Unified Organization Creates More Choices for Community Oncology

Together, McKesson and US Oncology will provide oncology practices with a robust suite of practice-support options and services, which can be tailored to meet each customer's specific needs. US Oncology's existing Comprehensive Strategic Alliance (CSA) practice-management offering and core services will remain intact, while the combined organization will offer a broad array of a la carte technology, practice-management, reimbursement and clinical services to the community oncology segment. US Oncology does not employ the physicians or own the practices affiliated with the company, and all customers will retain the flexibility to select the business-relationship model that best suits their individual needs.

"This strategic acquisition is a logical next step in our commitment to ensure the continued vitality of community oncology, while creating value for our shareholders," concluded Hammergren. "We look forward to welcoming US Oncology's innovative, experienced employees to McKesson and to working together with our customers to create better health for our customers and the patients they serve."

About US Oncology

US Oncology, Inc. is the nation's leading integrated oncology company. By uniting the largest community-based cancer treatment and research network in America, US Oncology expands patient access to high-quality care and advances the science of cancer care. Headquartered in The Woodlands, Texas, US Oncology is affiliated with more than 1,300 community-based oncologists, and works with patients, hospitals, payors and the medical industry across all phases of the cancer research and delivery continuum. By promoting the use of innovative technology, clinical research, evidence-based medicine and shared best practices, US Oncology improves patient outcomes and offers a better patient experience.

About McKesson

McKesson Corporation, currently ranked 14th on the FORTUNE 500, is a healthcare services and information technology company dedicated to helping its customers deliver high-quality healthcare by reducing costs, streamlining processes, and improving the quality and safety of patient care. Over the course of its 177-year history, McKesson has grown by providing pharmaceutical and medical-surgical supply management across the spectrum of care; healthcare information technology for hospitals, physicians, homecare and payors; hospital and retail pharmacy automation; and services for manufacturers and payors designed to improve outcomes for patients.

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Cellceutix Corp. (CTIX) - Kevetrin: Breast Cancer Drug

By Andrea: http://nursingoncologyjob.com

Recently, Cellceutix Corp. (CTIX) made an exciting announcement on their trial cancer drug: Kevetrin. Kevetrin in early studies, has demonstrated significant delay of Tumor growth in drug resistant cancer:

Cellceutix Corporation (CTIX) today announced that it has completed its second and final species toxicity study under the conditions prescribed by United States Food and Drug Administration (FDA) Good Laboratory Practices regulations. This is the last safety study required for an Investigational New Drug (IND) filing. In the study, animals were administered five doses of Kevetrin™ weekly over a 29 day period. Three groups of 14 animals were administered 5 mg/kg, 25 mg/kg and 60 mg/kg respectively while a fourth group acted as controls. There was a 14 day recovery period after the dosing. Parameters measured were hematology, clinical chemistries, weight change, food consumption, survival, urinalysis, ophthalmic examination and histopathology. This study, as well as the earlier toxicity and safety pharmacology studies, were performed by Toxikon, in Bedford, Massachusetts.

"This is the last safety study we had to complete prior to IND filing and we are extremely pleased with the results," said Dr. Krishna Menon, Chief Scientific Officer of Cellceutix. "Having now seen the data from all the required studies, I am very excited about the future of this compound in development for cancers that are resistant to standard therapies."

"This is an extraordinary milestone for a young company like ours," said George Evans, CEO of Cellceutix. "We would like to acknowledge our partner for these studies, Toxikon Corporation, who provided us with high quality work and excellent customer service. We believe we are now well on our way to an IND filing later this year or early next."

"We are proud to have led these important toxicology studies and help Cellceutix achieve its goal of getting Kevetrin to human trials and, ultimately, to market," said Dr. Laxman Desai, president and CEO of Toxikon, adding that "Toxikon is equipped to meet the industry's anticancer and antiviral drug discovery demands."

About Cellceutix

Cellceutix Corporation is a preclinical cancer, anti-inflammatory and autism drug developer. Cellceutix owns the rights to eight drug compounds, including Kevetrin, which it is developing as a treatment for certain cancers, and KM-391, which it is developing for the treatment of autism.

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BioSante Pharmaceuticals (BPAX): LibiGel Phase III

By Andrea: http://nursingoncologyjob.com

BioSante Pharmaceuticals, Inc. (BPAX) recently announced enrollment of the 2,500th woman in the LibiGel (testosterone gel) Phase III cardiovascular and breast cancer safety study. This important enrollment milestone triggers the first unblinded statistical analysis of cardiovascular events by the independent Data Monitoring Committee (DMC), which coincides with their fourth unblinded review of all adverse events. LibiGel is being developed for the treatment of female sexual dysfunction (FSD), specifically, hypoactive sexual desire disorder (HSDD) in menopausal women, for which there is currently no FDA approved product. BioSante anticipates the submission of a new drug application (NDA) for LibiGel in 2011.

The DMC's unblinded statistical analysis will determine whether the current study enrollment of 2,500 is sufficient to prove statistically the relative safety of LibiGel compared to placebo after an average of 12 months of exposure is reached, or if enrollment will continue. To date, there have been only 14 adjudicated cardiovascular (CV) events, a rate of approximately 0.65 percent, and only seven diagnoses of breast cancer, a rate of approximately 0.32 percent, after approximately 2,300 women-years of exposure in the study. BioSante will remain blinded as to the distribution of the reported safety events between the active and placebo study arms.

If enrollment continues beyond 2,500 women, an additional unblinded statistical analysis will be conducted by the DMC each time a new cardiovascular event is adjudicated. At each of these analyses the trial potentially could be fully enrolled. If enrollment is not completed sooner, enrollment will continue until the study reaches its predetermined maximum of 4,000 women.

"This milestone gives BioSante our first opportunity potentially to declare completion of enrollment in the safety study," stated Michael Snabes, M.D., Ph.D., BioSante's senior vice president of medical affairs. "We have had an extremely low number of cardiovascular and breast cancer events to date, as well as three previous favorable DMC recommendations. We expect the study to demonstrate the safety of LibiGel in the treated population, regardless of whether the DMC stops enrollment at 2,500 women or we need to continue enrollment."

About the LibiGel Phase III Cardiovascular and Breast Cancer Safety Study
The Phase III LibiGel safety study is a randomized, double-blind, placebo-controlled, multi-center, cardiovascular (CV) events and breast cancer study that will enroll between 2,500 and 4,000 women. The study will continue for a total of five years, however, BioSante can use the safety study data as part of an NDA submission after an average of 12 month exposure to LibiGel or placebo. BioSante anticipates the submission of a new drug application (NDA) for LibiGel in 2011.

The LibiGel safety study is tracking a predefined list of CV events, in agreement with the FDA, including CV death, myocardial infarction and stroke in women 50 years of age or older and suffering from at least two CV risk factors including hypertension and diabetes. The objective of the safety study is to show the relative safety of testosterone compared to placebo in the number of CV events. The incidence of breast cancer also is being tracked over the course of the study.

About LibiGel®
LibiGel is a testosterone gel in Phase III clinical development for the treatment of women who suffer from female sexual dysfunction (FSD). The on-going Phase III efficacy trials are double-blind, placebo-controlled trials that will enroll up to approximately 500 surgically menopausal women each for a six-month clinical trial. The efficacy trials are being conducted under an FDA-approved special protocol assessment (SPA) agreement. LibiGel is absorbed quickly through the skin after a once-daily pea-sized application on the upper arm, delivering testosterone to the bloodstream evenly over time and in a non-invasive and painless manner.

In a Phase II trial, LibiGel significantly increased the number of satisfying sexual events in surgically menopausal women suffering from FSD by 238 percent versus baseline (p<0.0001); this increase also was significant versus placebo (p<0.05). In this study, the effective dose of LibiGel produced testosterone blood levels within the normal range for pre-menopausal women and had a safety profile similar to that observed in the placebo group. In addition, no serious adverse events and no discontinuations due to adverse events occurred in any subject receiving LibiGel. The Phase II clinical trial was a double-blind, placebo-controlled trial, conducted in the United States, in surgically menopausal women distressed by their low sexual desire and activity.

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Apricus Biosciences, Inc. (APRI) - PrevOnco: hepatocellular carcinoma drug

By Andrea: http://nursingoncologyjob.com

Apricus Biosciences, Inc., (APRI) today announced the formation of a Clinical Advisory Board focused on the development of its investigational oncology compound, PrevOnco(TM). The Clinical Advisory Board is chaired by Stephen B. Howell, who also serves as Chairman of the Company's Scientific Advisory Board ("SAB"). Additional members of the Clinical Advisory Board include, Drs. Ghassan K. Abou-Alfa, Melanie Thomas, Robert G. Gish and Yehuda Patt.

Apricus Bio is developing PrevOnco, a marketed anti-ulcer compound, lansoprazole, to treat patients with advanced, unresectable hepatocellular carcinoma, or liver cancer. The Company is finalizing the Special Protocol Assessment ("SPA") Phase 3 registration protocol for a comparator study against doxorubicin in patients who have failed treatment with Nexavar(R) (the currently marketed first-line anti-cancer treatment for patients with either hepatocellular carcinoma , or advanced renal cell carcinoma). Subject to positive data, the Phase 3 study would be expected to support the filing of a New Drug Application for marketing approval in the U.S. and Europe. Management expects to submit the SPA Phase 3 protocol to the U.S. Food & Drug Administration ("FDA") before year-end 2010.

In the U.S., Nexavar is marketed by Onyx Pharmaceuticals, Inc. and Bayer HealthCare Pharmaceuticals, Inc., and is approved in more than 90 countries for the treatment of patients with liver cancer.

Commenting on today's news, Dr. Bassam Damaj, President and Chief Executive Officer of Apricus Bio, stated, "We are pleased to be able to, once more, tap the extraordinary expertise of Dr. Howell. Additionally, we are delighted to welcome Drs. Abou-Alfa, Thomas, Gish and Patt. Together, they will be instrumental in helping us move this important clinical program forward."

Dr. Howell, Chairman of the Company's SAB, commented, "We have assembled an impressive group of key opinion leaders. Having been involved in the clinical development of Nexavar, their experience in developing new hepatocellular carcinoma therapies will be invaluable to us as we finalize the SPA for submission to the FDA."

Dr. Howell is a medical oncologist and Professor of Medicine at the University of California, San Diego. He also serves as Associate Director for Clinical Research and Director of the Cancer Therapeutics Training Program at the Moores Comprehensive Cancer Center at the University of California, San Diego, and runs the Clayton Foundation Drug Resistance Laboratory at the Cancer Center. During his career, Dr. Howell has co-founded three pharmaceutical companies, including DepoTech (1989), Beacon Laboratories (1995), and Targa Pharmaceuticals (2003), serving as Medical Director of each. He holds a number of patents for his innovative work in chemotherapeutics, drug-delivery systems, and diagnostic assays and is the recipient of numerous awards. He is currently one of the main organizers of the American Association of Cancer Research.

Dr. Ghassan K. Abou-Alfa is a board-certified medical oncologist at Memorial Sloan-Kettering Cancer Center, specializing in primary liver cancer (hepatocellular carcinoma), pancreas, gallbladder, and bile duct tumors. He is involved in research focusing on improving the effectiveness of cancer therapy by incorporating small, novel biological molecules that target cancer into the treatment of chemotherapy-resistant gastrointestinal malignancies, particularly hepatobiliary and pancreatic cancers. Dr. Abou-Alfa received his M.D. from American University of Beirut, and completed residencies and fellowships at Yale University School of Medicine.

Dr. Melanie Thomas, M.S., is an Associate Professor and Associate Director of Clinical Investigations and the Grace E. DeWolf Chair of Medical Oncology at MUSC Hollings Cancer Center in Charleston, South Carolina. She earned her M.D. from Boston University School of Medicine and her M.S. from Harvard University. Dr. Thomas' professional interests include, hepatocellular, pancreatic, gallbladder, biliary and colorectal cancer.

Dr. Robert G. Gish serves as Chief of Clinical Hepatology, Professor of Clinical Medicine and co-director of the Center for Hepatobiliary Disease and Abdominal Transplantation (CHAT) at the University of California, San Diego School of Medicine. He is a NIH-funded researcher whose work focuses on the epidemiology of liver disease, biomarkers for liver disease and multi-targeted therapies for liver cancer. Dr. Gish received his medical degree from the University of Kansas in Kansas City. He completed his internship and residency in internal medicine at the University of California, San Diego School of Medicine and a fellowship in Gastroenterology and Hepatology at the University of California, Los Angeles. He is board certified in Internal Medicine and Gastroenterology and has the advance Certificate of Added Qualification (CAQ) in Liver Transplantation and is a UNOS certified Liver Transplant Physician.

Dr. Yehuda Patt is a Professor of Internal Medicine and the Director of Gastrointestinal Oncology Research at the University of New Mexico Cancer Center in Albuquerque, NM. He attended the Hebrew University and Hadassah Medical School, and completed his residency at Sheba Medical Center in Tel Aviv, Israel, and fellowship at the Anderson Hospital and Tumor Institute in Houston, Texas.

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Seattle Genetics, Inc. (SGEN): brentuximab vedotin (SGN-35) Hodgkin Lymphoma Drug Update

By Andrea: http://nursingoncologyjob.com

Seattle Genetics, Inc.(SGEN) and Millennium: The Takeda Oncology Company, a wholly owned subsidiary of Takeda Pharmaceutical Company Limited , today announced that brentuximab vedotin (SGN-35) will be featured in three poster presentations at the 8th International Symposium on Hodgkin Lymphoma (ISHL) being held October 23-26, 2010 in Cologne, Germany.

The following posters will be presented on Tuesday, October 26, 2010:

Objective responses with SGN-35 retreatment in CD30-positive hematologic malignancies: a case series (Abstract #113) Activity, safety and tolerability of antibody-drug conjugate (ADC) SGN-35 in relapsed/refractory Hodgkin lymphoma and CD30+ hematologic malignancies (Abstract #74) Activity of SGN-35 in preclinical models of combination therapy and relapse prevention (Abstract #49)

"These presentations complement the recent positive results from our pivotal Hodgkin lymphoma and phase II systemic anaplastic large cell lymphoma (ALCL) trials, both in the relapsed or refractory setting, and describe the additional opportunities we are pursuing to meet the needs of patients with CD30-positive malignancies," said Thomas C. Reynolds, M.D., Ph.D., Chief Medical Officer of Seattle Genetics. "In addition, we are preparing our brentuximab vedotin Biologics License Application (BLA) for submission to the U.S. Food and Drug Administration (FDA) in the first half of 2011."

"The acceptance of these presentations at ISHL underscores the scientific community's continued interest in brentuximab vedotin," said Nancy Simonian, M.D., Chief Medical Officer of Millennium. "We maintain our focus on meeting with regulators in Europe to discuss filing strategies in relapsed or refractory Hodgkin lymphoma and relapsed or refractory ALCL."

About Brentuximab Vedotin

Brentuximab vedotin is an ADC comprising an anti-CD30 monoclonal antibody attached by an enzyme cleavable linker to a potent, synthetic drug payload, monomethyl auristatin E (MMAE) utilizing Seattle Genetics' proprietary technology. The ADC employs a novel linker system that is designed to be stable in the bloodstream but to release MMAE upon internalization into CD30-expressing tumor cells. This approach is intended to spare non-targeted cells and thus may help minimize the potential toxic effects of traditional chemotherapy while allowing for the selective targeting of CD30-expressing cancer cells, thus potentially enhancing the antitumor activity.

Seattle Genetics and Millennium recently reported top-line data from a pivotal trial of brentuximab vedotin for relapsed or refractory Hodgkin lymphoma and a phase II trial for relapsed or refractory ALCL. In the pivotal Hodgkin lymphoma trial, 75 percent of patients achieved an objective response as assessed by an independent central review. The median duration of response was greater than six months. In the phase II ALCL trial, 86 percent of patients achieved an objective response as assessed by an independent central review. The median duration of response has not yet been reached at a median follow up on study of approximately six months. The safety profile of brentuximab vedotin in these trials was generally consistent with prior clinical trial experience. More complete data sets from both trials will be presented in oral sessions at the American Society of Hematology (ASH) annual meeting, December 4-7, 2010, in Orlando, FL.

The companies are also conducting a phase III clinical trial (the AETHERA trial) for patients at high risk of residual Hodgkin lymphoma following autologous stem cell transplant, a phase II retreatment trial for relapsed patients who previously responded to brentuximab vedotin, and a phase I combination trial for the front-line treatment of Hodgkin lymphoma.

About the Seattle Genetics/Millennium Collaboration

Seattle Genetics and Millennium are jointly developing brentuximab vedotin. Under the terms of the collaboration agreement, Seattle Genetics has U.S. and Canadian commercialization rights and the Takeda Group has rights to commercialize brentuximab vedotin in the rest of the world. Seattle Genetics and the Takeda Group are funding joint development costs for brentuximab vedotin on a 50:50 basis, except in Japan where the Takeda Group will be solely responsible for development costs.

About Hodgkin Lymphoma

Lymphoma is a general term for a group of cancers that originate in the lymphatic system. There are two major categories of lymphoma: Hodgkin lymphoma and non-Hodgkin lymphoma. Hodgkin lymphoma is distinguished from other types of lymphoma by the presence of one characteristic type of cell, known as the Reed-Sternberg cell. A defining attribute of the Reed-Sternberg cell is its expression of the CD30 antigen.

According to the American Cancer Society, approximately 8,500 cases of Hodgkin lymphoma will be diagnosed in the United States during 2010 and more than 1,300 will die from the disease. Globally, there are more than 30,000 cases of Hodgkin lymphoma diagnosed each year. Although front-line combination chemotherapy can result in durable response rates, up to 30 percent of these patients relapse or are refractory to front-line treatment and have few therapeutic options beyond autologous stem cell transplant.

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Eli Lilly and Co. (LLY) - Teplizumab: Autoimmune Drug Update

By Andrea: http://nursingoncologyjob.com

MacroGenics, Inc. and Eli Lilly and Company (LLY) today announced that the Protege Data Monitoring Committee (DMC), composed of independent experts in the fields of diabetes and biostatistics, has completed a planned analysis of one-year safety and efficacy data of the Protege Phase 3 clinical trial of teplizumab, an investigational biologic under development for the treatment of individuals with recent-onset type 1 diabetes.

The DMC concluded that the primary efficacy endpoint of the study, a composite of a patient's total daily insulin usage and HbA1c level at 12 months, was not met. The DMC, noting that all administration of experimental drug had been completed, commented that appropriate safety monitoring is warranted. No unanticipated safety issues were identified in the DMC's review.

"We will comply with the DMC's recommendations," said Scott Koenig, M.D., Ph.D., President and Chief Executive Officer, MacroGenics. "We remain committed to discovering and developing novel biologics for the treatment of autoimmune disorders like type 1 diabetes."

Following careful evaluation of the DMC's recommendations for Protege, based on the lack of efficacy, the companies have decided to suspend further enrollment and dosing of patients in two other ongoing clinical trials of teplizumab in type 1 diabetes: the Protege Encore Trial, a second Phase 3 trial of the same design as Protege, and the SUBCUE trial, a Phase 1b trial that is exploring the subcutaneous administration in patients with type 1 diabetes.

"The failure to meet the primary endpoint is obviously disappointing for the millions of people who live with and treat type 1 diabetes," said Gwen Krivi, Vice President, Product Development, Lilly Diabetes. "Lilly and MacroGenics will be considering all options for teplizumab in type 1 diabetes as well as the impact of the DMC's recommendations on other potential indications."

About Type 1 Diabetes

Type 1 diabetes is an autoimmune disease in which the body's immune system attacks and destroys the insulin-producing beta cells of the pancreas. Insulin is a hormone that is needed to convert sugar (glucose), starches and other food into energy needed for daily life. People with type 1 diabetes must take multiple injections of insulin daily or continually infuse insulin through a pump to manage their blood glucose levels.

Type 1 diabetes, previously known as juvenile diabetes, usually strikes in childhood, adolescence, or young adulthood, but lasts for a lifetime. Of the nearly 24 million Americans who have diabetes, as many as 3 million may have type 1.(i)

About Teplizumab

Teplizumab, also called MGA031 and hOKT31 (Ala-Ala), is a humanized, anti-CD3 monoclonal antibody. Teplizumab binds to an epitope of the CD3-epsilon chain expressed on mature T lymphocytes and, by doing so, may modulate the pathological immunologic responses underlying multiple autoimmune diseases. Specifically, teplizumab may inhibit unwanted effector T cells and enhance beneficial regulatory T cell functions, thus promoting immune tolerance.

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Genentech: Avastin Breast Cancer Drug

By Andrea: http://nursingoncologyjob.com

Genentech, Inc., a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY),recently announced that information submitted by the company to the U.S. Food and Drug Administration (FDA) during the review of the supplemental Biologics License Applications (sBLAs) for Avastin® (bevacizumab) for previously untreated (first-line) advanced HER2-negative breast cancer has been deemed a major amendment. In accordance with FDA guidelines, the agency has extended the review period for the sBLAs by an additional 90 days. The company now anticipates FDA action on the sBLAs by December 17, 2010.


At this time, Avastin remains under accelerated approval in combination with paclitaxel for the first-line treatment of HER2-negative metastatic breast cancer. The FDA is currently reviewing two sBLAs that Genentech submitted in November 2009 for Avastin in combination with taxane-based, anthracycline-based and capecitabine chemotherapies based on the results of the AVADO and RIBBON1 studies. Data from AVADO and RIBBON1 were submitted as part of Genentech's effort to convert the accelerated approval to a full approval.


"We are pleased by the FDA's decision to review additional information on Avastin and are committed to working closely with the agency during this extended review period," said Hal Barron, M.D., executive vice president, Product Development and chief medical officer.


Today's announcement does not impact Avastin's availability for its approved uses for other cancer types in the U.S. or approved uses, including breast cancer, in other countries. Doctors with questions about the use of Avastin for advanced breast cancer can call Genentech's Medical Communications group at (800) 821-8590. Patients with questions or concerns about insurance coverage or doctors with questions about reimbursement can call Genentech's Access Solutions Group at (866) 4 ACCESS.


In February 2008, FDA granted accelerated approval for Avastin in combination with paclitaxel chemotherapy for first-line treatment of advanced HER2-negative breast cancer. The approval was based on an improvement in progression-free survival (PFS). Avastin is not approved for patients with breast cancer that has progressed following anthracycline and taxane chemotherapy administered for metastatic disease. There are no data available showing that Avastin improves disease-related symptoms or survival in advanced HER2-negative breast cancer.


About Avastin
Avastin is a prescription-only medicine that is a solution for intravenous infusion. It is a biologic antibody designed to specifically bind to a protein called VEGF (vascular endothelial growth factor) that plays an important role throughout the lifecycle of the tumor to develop and maintain blood vessels, a process known as angiogenesis. Avastin interferes with the tumor blood supply by directly binding to the VEGF protein to prevent interactions with receptors on blood vessel cells. Avastin does not bind to receptors on normal or cancer cells. The tumor blood supply is thought to be critical to a tumor's ability to grow and spread in the body (metastasize). For more information about angiogenesis, visit http://www.gene.com.


Avastin is approved for first- and second-line treatment of metastatic colorectal cancer (mCRC) in combination with intravenous 5-FU-based chemotherapy, first-line treatment of unresectable, locally advanced, recurrent or metastatic, non-squamous, non-small cell lung cancer (NSCLC) in combination with carboplatin and paclitaxel, and metastatic renal cell carcinoma in combination with interferon alfa.

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