Does Imlygic Make The Case For FDA Oncology Center Of Excellence?
Products like Amgen's viral therapy for melanoma could benefit under proposals to replace FDA's modality-based organization with disease-specific centers. FDA's biologics center proved itself capable of reviewing the oncologic, but the drugs center already had extensive recent experience with the fast-changing melanoma market.
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Patient Voices Swayed FDA's Imlygic Review Team
Testimony from patients about the cosmetic and psychological advantages of seeing melanoma lesions shrink was a key element in agency's decision to offer full approval to Amgen's talimogene laherparepvec despite serious concerns about the clinical meaning of the pivotal trial's durable response rate endpoint.
FDA Reorganization Advocates Seek Senate Boost For Disease-Oriented Structure
Friends of Cancer Research proposes realignment of medical product functions by disease area without regard to modality; former commissioners give some support but new drugs Director Jenkins warns about unintended consequences that could negatively impact innovation and approvals.
Melanoma Approvals Break New Ground In Immunotherapy
First adjuvant and combination approvals for immuno-oncology could help revive Yervoy in melanoma; Amgen’s oncolytic cancer vaccine emerges as new mechanism for select patients, with room to grow.