FDA panel backs GSK's Votrient for soft-tissue sarcoma

Good news came for GlaxoSmithKline ($GSK) Tuesday after the FDA's Oncologic Drugs Advisory Committee voted 11-2 in favor of approving Votrient to treat patients with advanced soft-tissue sarcoma who have received prior chemotherapy. The FDA approved Votrient to treat advanced renal-cell carcinoma in 2009.

However, the panel didn't have good news for Merck ($MRK) and Ariad Pharmaceuticals ($ARIA). The two hoped the panel would smile upon their investigational agent ridaforolimus as maintenance therapy for the soft-tissue sarcoma. But the panel voted 13-1 to recommend against this use.

A jubilant GSK praised the panel's vote in its favor. "Treatment options for patients with advanced soft-tissue sarcoma are limited; we are therefore pleased that the committee took a favorable view of the clinical data for Votrient," said Rafael Amado, senior VP of GSK Oncology.

According to study results, Votrient boosted progression-free survival to a median of 4.6 months, 3.1 months longer than a placebo. "It's a little step, but it's a little step in a field that has had nothing," said panel member Lee Helman during the meeting, as quoted by Bloomberg.

The panel determined, however, the Merck-Ariad med didn't confer the same benefit. In fact, patients on ridaforolimus had a median progression-free survival of 17.7 weeks versus 14.6 weeks for those taking placebo, as Dow Jones notes. Given the small survival difference, and the potential for such side effects as infection, rash and in some cases kidney damage, the panel decided not to vote for the drug's approval.

- check out GSK's statement
- see the Merck/Ariad release
- read the Bloomberg Businessweek story
- see the Dow Jones item