Afinitor approved for rare pancreatic cancer

Late yesterday on May 5, the Food and Drug Administration approved Afinitor (everolimus) to treat patients with metastatic or inoperable advanced pancreatic neuroendocrine tumors (PNET), sometimes also called islet cell tumors. Patients with this rare tumor type have few treatment options, and there hasn't been a new treatment approved in about 30 years.The approval was expected and comes on the heels of a unanimous recommendation from the FDA's Oncologic Drugs Advisory Committee (ODAC) on April 12.The committee's decision was based on the phase 3 trial RADIANT-3, which randomly assigned 410 patients to either receive Afinitor or a placebo. Afinitor showed more than double the progression free survival, which was 11 months with the drug compared with 4.6 with placebo. Patients on placebo were given the opportunity to receive Afinitor after disease progression. Data on overall survival is not yet available. You can read more details about the study in the Feb. 10 issue of The New England Journal of Medicine.The most common side effects from Afinitor reported were mouth inflammation, rash, diarrhea, fatigue and infection (generally upper respiratory). Afinitor also is approved for treating patients with advanced kidney cancer who have been previously treated with Nexavar (sorafenib) or Sutent (sunitinib). Sutent incidentally was also recommended by the ODAC for treating pancreatic neuroendocrine tumors but has yet to receive FDA approval.