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Amgen's T-Vec Receives Poor FDA Staff Review
The accelerated review, the results of which were made public 2 days prior to a vote by an FDA advisory panel on using T-Vec in melaonma, cited concerns over the design and results of a key study with the viral drug.
FDA staff reviewers said an accelerated review of drugmaker Amgen Inc's skin cancer immunotherapy cannot be considered at this time, citing concerns over the design and results of a key study.
The reviewers said in documents made public on Monday that it was unclear whether the treatment, a cancer-killing virus called talimogene laherparepvec or "T-Vec", improved overall survival, raising questions over its effectiveness. The review comes two days before a panel of FDA advisers votes on whether T-Vec should be approved to treat melanoma.
The FDA typically accepts the panel's recommendations.
Link to the Reuter's news:
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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