FDA pushes cancer drug developers to include overall survival data more frequently

For years, the FDA has al­lowed pro­gres­sion-free sur­vival to serve as both a pri­ma­ry and sur­ro­gate end­point to sup­port speedy new can­cer drug ap­provals. But with new class­es of on­col­o­gy drugs com­ing to the fore­front, the agency ap­pears to be in­creas­ing­ly call­ing for more ro­bust over­all sur­vival da­ta that can prove treat­ments help pa­tients live longer.

The ap­par­ent move­ment by the FDA, par­tic­u­lar­ly when the OS da­ta aren’t ma­ture, hasn’t ar­rived in the form of draft guid­ance, but via a con­fer­ence and side com­ments from FDA’s top on­col­o­gy ex­pert. This push for more OS da­ta, on top of PFS da­ta, was raised by No­var­tis CEO Vas Narasimhan last week dur­ing the com­pa­ny’s quar­ter­ly earn­ings call, when he called it “new ter­ri­to­ry” for the agency.

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