You don't have to head to spring training to see a big doubleheader this week. A panel of outside experts will determine the fate of two drugs affecting three different companies at a pair of advisory panel meetings tomorrow. Whether the companies hit it out of the park or go down swinging depends on whether the advisors think a small benefit in delaying cancer is worth the potential side effects.
First up, GlaxoSmithKline
In the afternoon, the panel will review Merck's
Overall survival is what patients and doctors care about, but PFS can be a decent surrogate if there's a clinically meaningful difference. What's the definition of clinically meaningful? It depends on what else is available. Pfizer's
Votrient will likely have an easier time getting past the panel because it was being tested in patients who had failed chemotherapy. With no other options, even a small difference is meaningful.
Ridaforolimus was tested as a maintenance therapy for patients who responded to chemotherapy. Because it's designed to be taken for a long period of time, side effects will come into play -- 14% of treated patients dropped out because of adverse events versus just 2% in the placebo arm of the trial. The marginal increase in survival might not be worth experiencing the adverse effects.
The advisory panel will make its recommendation on both drugs tomorrow, but investors will have to wait until the baseball season is in full swing to find out the ultimate fates of the drugs. Votrient is scheduled to get an FDA decision on or around May 6, while the decision on ridaforolimus will come closer to June 5.