FDA Reiterates Preference For Overall Survival Data For Lung Cancer Approvals
FDA’s final guidance on lung cancer trial endpoints says that overall survival is the optimal test of efficacy, but reaffirms that progression-free survival primary endpoint may support approval if the magnitude of effect is “substantial and statistically robust.”
You may also be interested in...
Merck & Co has gained its first positive opinion for Keytruda from Europe’s top advisory panel the CHMP, while Bristol-Myers Squibb’s Opdivo has received its second positive opinion, for use in lung cancer.
FDA is using its new draft guidance on non-small cell lung cancer to once again stress the importance of using overall survival to prove efficacy and make clear that if progression-free survival measure is used, a “substantial and robust” effect should be shown.
Part 2: High costs are built into the rare disease business model. Participants at a roundtable discussion led by Scrip at the J.P. Morgan Healthcare Conference talked about how much they are feeling the pressure on pricing.