- The Food and Drug Administration announced after the close of the market on Monday that it has approved Puma Biotechnology's neratinib under the brand name Nerlynx for patients with early stage HER2-overexpressed/amplified breast cancer, to prevent recurrence after taking Roche's Herceptin (trastuzumab).
- The recommended dose is 240 mg (6 tablets) given orally once daily with food, continuously for one year. The agency recommends administering antidiarrheal medication through the first 56 days of treatment and as needed after.
- The label includes a warning to permanently discontinue the drug if there is Grade 4 diarrhea or greater than Grade 2 diarrhea that occurs after maximal dose reduction.
Speculation that the Food and Drug Administration under Scott Gottlieb may be a bit more lax has mounting evidence after Puma got a surprise approval ahead of its July 21 user fee goal date.
An advisory committee in May raised questions about the validity of the ExteNET study, which was the ultimate basis for approval. The trial spanned nearly eight years and switched sponsorships multiple times: from Wyeth to Pfizer, and finally, to Puma. The different sponsors made major amendments to the study, which caused some uncertainty from the panel about its results. Ultimately though, the Oncology Drugs Advisory Committee voted in favor of approval with a 12 to four vote, but the panel called for a more limited indication.
Puma expects to have the drug available in the U.S. market by September 2017.
The approval will pit Puma almost directly against Roche's Perjeta (pertuzumab), which is already approved in combination with Herceptin to treat metastatic breast cancer. Data presented earlier this year also showed that the combination could help prevent recurrence after surgery.
Data presented from Roche at the American Society of Clinical Oncology meeting this year could further help boost the Perjeta/Herceptin combination and make it harder for Puma to carve out a niche.