US FDA panel backs Novartis' Afinitor and Pfizer' Sutent for rare cancer, and agency OKs Merck & Co's Sylatron for melanoma

There was a bunch of US regulatory news yesterday for three top pharma companies, with positive opinions for Switzerland’s Novartis (NOVN: VX) and the USA’s Pfizer (NYSE: PFE) and Merck & Co (NYSE: MRK) from the Food and Drug Administration or its advisory panels.

As had been generally expected, the FDA’s Oncologic Drugs Advisory Committee (ODAC) last evening recommended approval of Swiss drug major Novartis’ (Afinitor (everolimus) for the treatment of patients with advanced neuroendocrine tumors (NET) of pancreatic origin, voting 10 to 0 to back the drug.

The recommendation was provided after presentation of data from the everolimus RADIANT (RAD001 In Advanced Neuroendocrine Tumors) trial program, the largest conducted in patients with advanced NET. The Phase III RADIANT-3 trial studied patients with advanced NET of pancreatic origin and showed a statistically significant improvement in progression-free survival with everolimus versus placebo. The FDA can seek the advice of its advisory committees as it reviews and decides whether to approve treatments, although it is not obliged to follow the recommendation.