GlaxoSmithKline submitted follow-up data and information to the FDA for Cervarix, the company's cervical cancer drug. Cervarix would become the second HPV vaccine on the market in the US, competing with Merck's Gardasil. GSK submitted data from its phase 3 trials, HPV-008. FDA had already reviewed interim data from the same trial, and requested more information. GSK expects FDA's review of Cervarix's biologics license application to take six months.
Novartis announced FDA's approval of Afinitor, a kidney cancer drug. Afinitor is indicated for patients with advanced renal cell carcinoma, after failure of treatment with sunitinib or sorafenib.