A first test of whether the drive to require larger numbers of patients enrolled in clinical trials to measure overall survival as an endpoint (rather than progression free survival) in the wake of FDA's Avastingate is due this week:
"Seattle Genetics Inc. (SGEN) and Takeda Pharmaceutical Co.’s drug brentuximab for Hodgkin’s lymphoma and a less common type of the disease may require more data on benefits compared with treatments already on the market, U.S. regulators said.
The Food and Drug Administration is trying to determine whether the experimental treatment given the trade name Adcetris should receive accelerated approval in an agency staff report released today. An FDA panel of outside advisers on July 14 will weigh applications for the medicine to treat anaplastic large cell lymphoma and Hodgkin’s lymphoma.
The agency is seeking more patient data to be able to weigh more clearly the drug’s benefits. The FDA may decide whether to approve by Aug. 30. The experimental treatment could generate peak sales of $850 million in 2020, according to a note last month from Rachel McMinn, a research analyst with Bank of America Merrill Lynch.
“Small size limits the benefit-risk analysis,” the FDA said in questions to outside advisers released with its report. “For this application, consideration for accelerated approval would be consistent with regulatory actions taken in the past decade for similar hematology applications based on single arm clinical trials.”
We know what that might mean for cancer patients in Pazdur-land.Meanwhile as I blogged a couple of weeks ago, the Kevorkian Center for FDA Reform run by Harvard's resident anti-innovation scold Jerry "Use My Academic Detailing Without Evidence of Improved Outcomes" Avorn is pushing for longer and larger studies that would run small firms like Seattle Genetics into bankruptcy...
You can read Avorn and his colleague Aaron Kesselheim's blueprint to ration innovations by expanding clinical trials here:
