FDA looks to pull the plug on Avastin’s breast cancer indication
SILVER SPRING, Md. — Just a few months after a Food and Drug Administration advisory committee recommended limiting the use of a Genentech drug designed to treat breast cancer, the regulatory agency is looking to revoke the approval altogether.
The FDA on Thursday said it was in the process of removing the breast cancer indication from Avastin (bevacizumab) after reviewing the results of four clinical studies, which indicated that the drug "does not prolong overall survival in breast cancer patients or provide a sufficient benefit in slowing disease progression to outweigh the significant risk to patients," the agency said.
The FDA issued its proposal to withdraw the drug to Genentech. The drug maker has the opportunity to request a public hearing if it wishes to contest the agency’s determination.
“After careful review of the clinical data, we are recommending that the breast cancer indication for Avastin be removed based on evidence from four independent studies,” said Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research. “Subsequent studies failed to confirm the benefit observed in the original trial. None of the studies demonstrated that patients receiving Avastin lived longer, and patients receiving Avastin experienced a significant increase in serious side effects. The limited effects of Avastin combined with the significant risks led us to this difficult decision. The results of these studies are disappointing. We encourage the company to conduct additional research to identify if there may be select groups of patients who might benefit from this drug.”
In July, the Oncologic Drugs advisory committee voted 12-to-1 that use of Avastin (bevacizumab) combined with paclitaxel chemotherapy as a first-line treatment for advanced HER2-negative breast cancer be removed from the drug’s labeling.
NACDS Foundation grants funds to expand CPRPs
ALEXANDRIA, Va. — The education, research and charitable affiliate of the National Association of Chain Drug Stores announced its contribution of $1.5 million in grants to expand the availability of Community Pharmacy Residency Programs for pharmacy graduates.
CPRPs allow pharmacy residents to focus on providing direct patient care, developing patient care services with pharmacist preceptor oversight, the NACDS Foundation said. The NACDS Foundation seeks to jumpstart 30 new community pharmacy residencies nationwide — a 25% increase in total residency positions.
“The NACDS Foundation is pleased to help support the growth of community pharmacy residencies. These programs have been integral in enhancing patient care services and integrating these services into the community pharmacy practice setting,” said NACDS Foundation president Edith Rosato.
Decision Resources: Linaclotide will capture IBS market
BURLINGTON, Mass. — An investigational treatment for irritable bowel syndrome could become a blockbuster by the end of the decade, according to a report by Decision Resources.
The report, which the healthcare market research firm said it would publish later this month, found that linaclotide — made by Ironwood Pharmaceuticals, Forest Labs, Almirall and Astellas Pharma — would emerge as the market leader for IBS and achieve sales of $1.1 billion in the United States, France, Germany, Italy, Spain, the United Kingdom and Japan by 2019.
The drug will benefit from the loss of patent protection and what Decision Resources called the limited efficacy of Amitiza (lubiprostone), made by Sucampo Pharmaceuticals, Takeda Pharmaceuticals and Abbott.
The report characterized the IBS market as highly fragmented and underserved due to a high rate of generic drug penetration and the disease’s heterogeneity.
“IBS is a highly prevalent chronic condition in the world’s major pharmaceutical markets, but the lack of a biochemical or histological marker for positive diagnosis and incomplete understanding of the disease’s pathophysiology and etiology have resulted in low diagnosis and treatment rates,” Decision Resources analyst Iva Holder said. “The limited number of efficacious treatment options suggests significant opportunity for new IBS therapies.”