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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.
Read the complete article at: http://bit.ly/1JghIHB
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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Texas Oncology to Roll Out Canopy for ePROs After Head-to-Head Pilot
March 18th 2025Debra Patt, MD, PhD, MBA, executive vice president of Public Policy and Strategy for Texas Oncology, said the practice received positive feedback from nurses and patients during a pilot that concluded in February.
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Examining Low-Value Cancer Care Trends Amidst the COVID-19 Pandemic
April 25th 2024On this episode of Managed Care Cast, we're talking with the authors of a study published in the April 2024 issue of The American Journal of Managed Care® about their findings on the rates of low-value cancer care services throughout the COVID-19 pandemic.
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