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Independent Committee Recommends T-Vec for Approval Despite FDA Staff Concerns
Amgen might be the latest entrant in the immunotherapy realm if the FDA heeds the advice of an independent advisory panel, recommending Amgen's anticancer viral therapy, T-Vec, for melanoma treatment.
Amgen Inc's skin cancer immunotherapy showed enough efficacy in the treatment of melanoma to be given marketing approval, an independent advisory panel to the FDA said on Wednesday.
The panel voted 22-1 supporting an approval for the therapy, talimogene laherparepvec or "T-Vec", an engineered virus that kills cancer cells when injected into tumors and also primes the immune system to attack the disease. The recommendation comes 2 days after FDA staff expressed concerns over the design and results of a key study on T-Vec and raised questions over the interpretation of data from a late-stage study.
Complete article on Reuters: http://reut.rs/1bgix4y
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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Higher Life’s Essential 8 Scores Associated With Reduced COPD Risk
November 21st 2024Higher Life’s Essential 8 (LE8) scores, especially those reflecting lower nicotine exposure and better sleep health, are inversely associated with chronic obstructive pulmonary disease (COPD) risk, emphasizing the importance of cardiovascular health (CVH) in disease prevention.
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