Roche Scores FDA Approval For First Immunotherapy Drug To Treat Breast Cancer
Despite the fact that costly immunotherapy drugs help only a small minority of patients, breast cancer doctors are calling the approval "tremendously exciting." In other pharmaceutical news: biologics and drugs for preventing premature births.
The Associated Press:
FDA Approves 1st Immunotherapy Drug To Treat Breast Cancer
The U.S. Food and Drug Administration has approved the first immunotherapy drug for breast cancer. Swiss drugmaker Roche's Tecentriq was OK'd Friday for treating advanced triple-negative breast cancer, which accounts for about 15 percent of cases. It's to be given with chemotherapy, the standard treatment. Mount Sinai breast cancer specialist Dr. Amy Tiersten in New York called it "tremendously exciting news." (3/8)
Stat:
Roche Wins First U.S. Approval Of Immunotherapy For Breast Cancer
The approval, as is typical, was narrow: for locally advanced or metastatic triple-negative breast cancer expressing PD-L1, the molecule that locks onto PD-1 receptors on the surface of T cells. (Triple-negative means the tumor cells do not have estrogen receptors, progesterone receptors, or HER2, all of which fuel uncontrolled cell proliferation but can be blocked with drugs such as Herceptin.) (Begley, 3/8)
Stat:
Microbiome-Based Drugs Likely To Face FDA's Biologics Pathway
It’s not really a stretch of the imagination to think that microbiome companies should care deeply about who will lead the Food and Drug Administration after the current commissioner, Scott Gottlieb, departs in a few weeks. After all, no microbiome-based drug has yet gone through the regulatory process and made it to market and investors are still skittish about how those drugs will be received by the agency. Yet a five-person panel of microbiome executives on a panel at the inaugural Chardan Microbiome Summit on Thursday didn’t address the shift in leadership until prompted by a member of the audience. (Sheridan, 3/11)
Stat:
Drug For Preventing Premature Births Disappoints AMAG Pharma
The long-running saga of the Makena treatment for preventing premature births has taken yet another twist as AMAG Pharmaceuticals (AMAG), which sells the drug, revealed it failed a confirmatory study. The trial found the treatment was no better than a placebo and the disclosure quickly raised speculation that the medicine, which was approved eight years ago, might be withdrawn, sending AMAG stock down nearly 20 percent in midday trading on Friday. (Silverman, 3/8)
