FDA documents show Rasonque responses varied by pancreatic cancer mutation

FDA review documents described differences in how Rasonque performed across KRAS mutations in pancreatic cancer, raising questions about how broadly the drug works. BioPharma Dive reported that, in the trial supporting FDA approval, tumor responses were markedly better than chemotherapy among patients with KRAS G12V, more modest among those with G12D, and worse among those with G12R. G12D patients represent the largest share of pancreatic cancer patients, the outlet reported. Endpoints News also reported that patients with the most common KRAS mutation appeared to have a lower response rate than the overall Rasonque population.

Rasonque was approved in August for patients whose cancer had progressed after chemotherapy, based on data showing it nearly doubled survival compared with chemotherapy, BioPharma Dive reported. Revolution Medicines shares fell 6% Thursday, according to BioPharma Dive. Endpoints News reported shares fell more than 6%.