Merck ($MRK) and Ariad Pharmaceuticals ($ARIA) face a big test for their experimental cancer drug ridaforolimus next week. In briefing docs released today, FDA staffers questioned whether the drug should be approved given the slim survival benefits that it provides. That will be a central question for FDA advisers to consider at an advisory committee meeting slated for March 20.
Merck and Ariad are seeking FDA approval of their drug as a maintenance therapy for patients with a rare form of cancer called soft tissue and bone sarcoma. In a late-stage trial, the drug helped patients live without their bone cancer getting worse for a median of 16.1 weeks compared with 14 weeks in the placebo arm, the FDA said, and patients on the drug had median overall survival of 20.8 weeks, slightly more than the 19.6 weeks in the placebo group. FDA staffers said those gains might fall short of providing enough of a benefit, Bloomberg reported.
GlaxoSmithKline ($GSK) will also face next week's FDA advisory panel with its application to gain approval for Votrient, which is already marketed for treating kidney cancer, to treat bone cancer. Bloomberg noted that the FDA staff review of the drug in bone cancer indicated that it doesn't increase overall survival.
No new red flags about the safety of Merck's or GSK's drugs were raised in the FDA staff documents, Reuters said.
Ariad has no drugs on the market and could garner a $25 million payment from Merck if the FDA approves ridaforolimus--an mTOR targeting compound--for bone cancer. If the drug doesn't fair well with regulators, Ariad also has in late-stage development a targeted drug known as ponatinib for treatment of chronic myeloid leukemia.
The FDA often follows the advice of its advisory committees in its approval decisions.
- see Bloomberg's report
- check out the Reuters article
- get the FDA briefing docs here