Here are five drugs the FDA will approve or deny this month.
- Tecentriq, developed by Basel, Switzerland-based Roche, is an immunotherapy drug under FDA review to treat patients with non-small cell lung cancer. Roche, which earned priority review status for the drug, expects a decision Oct. 19.
- Paris-based Sanofi and Tarrytown, N.Y.-based Regeneron Pharmaceuticalsdeveloped Sarilumab for patients with moderate to severe rheumatoid arthritis. The companies expect a response from the FDA Oct. 30.
- Kenilworth, N.J.-based Merck will learn if its drug Zinplava has been approved to prevent a recurrence of C. difficile infection in adult patients Oct. 23.
- Xtandi, which New York City-based Pfizer recently acquired from San Francisco-based Medivation, is a prostate cancer drug. On Oct, 22, the FDA will decide whether to approve a label change on the drug that would boost sales for Pfizer.
- Egalet, a specialty pharma company in Wayne, Pa,. developed Arymo ER to treat pain severe enough to require daily, long-term opioid treatment when alternative medications do not work. The FDA is expected to make a decision on the drug’s status on Oct. 14.
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