FDA staff finds Puma Biotech’s cancer drug effective, shares soar
Shares of Puma Biotechnology Inc surged about 80 percent on Monday after the U.S. Food and Drug Administration staffers concluded after a preliminary review that the company’s experimental breast cancer drug was effective.
However, the staff flagged concerns about the safety profile of the drug, neratinib.
Based on the sensitivity analyses conducted, the results appear to be generally similar to the primary analysis results, supporting an effect of neratinib, the staffers said.
Tolerability of the drug in the patient population is a concern given the frequent dose interruptions, reductions, and discontinuations observed, mostly due to diarrhea, the staff reviewers said on Monday. bit.ly/2rtvRyY
The FDA has scheduled an advisory committee meeting on May 24 to discuss the company’s breast cancer drug.
Puma’s shares gave up some of its gains to be up about 51 percent at $57.25 in morning trading. They touched $69.35 earlier in the session.
(Reporting by Ankur Banerjee in Bengaluru; Editing by Sriraj Kalluvila)