FDA Open to Surrogate Endpoints in Lung Cancer

Pharmaceutical companies can expect accelerated drug development by using alternate endpoints instead of the gold standard of OS and PFS for oncology molecules.

Companies will be permitted to use several types of clinical trial endpoints to show the efficacy of drugs intended to treat non-small cell lung cancer (NSCLC), the FDA confirmed in a new guidance document released this week.

The final guidance document, Clinical Trial Endpoints for the Approval of Non-Small Cell Lung Cancer Drugs and Biologics, is intended to clarify the evidence FDA is willing to accept in the review of new NSCLC drugs.

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Source: Regulatory Guidance Professional Society