On Monday morning, the U.S. Food and Drug Administration staff concluded that Puma Biotechnology Inc.’s (NASDAQ: PBYI) experimental breast cancer drug is effective. The preliminary review was positive but the staff also has concerns about the safety profile of the drug, neratinib.
The preliminary review was similar to primary analysis results. Although the drug proved effective, side effects include severe diarrhea which forced patients using the drug to reduce and or discontinue use.
The FDA has scheduled a meeting to review the PB272 (neratinib) at the Oncologic Drugs Advisory Committee (ODAC) meeting on May 24th. ODAC is an independent panel of experts that evaluates data concerning the efficacy and safety of marketed and investigational cancer treatments and makes appropriate recommendations to the FDA. Its comments are not binding, but are considered by the FDA in its decision-making process.
Neratinib is a potent irreversible tyrosine kinase inhibitor that blocks signal transduction through the epidermal growth factor receptors, HER1, HER2 and HER4. Currently, the Company is primarily focused on the development of the oral version of neratinib, and its most advanced drug candidates are directed at the treatment of HER2-positive breast cancer. The Company believes that neratinib has clinical application in the treatment of several other cancers as well, including non-small cell lung cancer and other tumor types that over-express or have a mutation in HER2.