FDA Acknowledges That Mediocre Is Sometimes All We Have
This opinion piece presents the opinions of the author. It does not necessarily reflect the views of BioSpace.
How well does Avastin work in glioblastoma? Honestly, not very well. But it's the best we have right now, underscoring the desperate need for better brain cancer treatments. Avastin has long been used off-label in this indication, but it now has full approval--based on a study showing it didn't extend overall survival but did give some modest improvement in progression-free survival and allowed more patients to get off corticosteroids.
No novel drugs have been approved since our last issue, but the docket is starting to fill for 2018. -KT
Here's a roundup of these stories and other top FDA actions from the past month.
- FDA Grants Genentech's Avastin Full Approval for Most Aggressive Form of Brain Cancer
- Amgen on a Roll as the FDA OKs Repatha to Prevent Heart Attack and Stroke
- FDA Green Lights Eli Lilly's Taltz to Treat Active Psoriatic Arthritis
- Foundation Medicine Wins Approval From the FDA and Medicare for First-of-Its-Kind Cancer Test
- U.S. FDA Approves Mylan and Biocon's Ogivri, the First Biosimilar for Trastuzumab, for the Treatment of HER2-Positive Breast and Gastric Cancers
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