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
Exploring Racial, Ethnic Disparities in Cancer Care Prior Authorization Decisions
October 24th 2024On this episode of Managed Care Cast, we're talking with the author of a study published in the October 2024 issue of The American Journal of Managed Care® that explored prior authorization decisions in cancer care by race and ethnicity for commercially insured patients.
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