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.
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Bristol's Opdivo and Novartis/GlaxoSmithKline's Tafinlar/Mekinist combo both performed well in early, post-surgical treatment of advanced melanoma in trials reported at ESMO, promising yet another revolution in the standard of care, but leaving Roche's Zelboraf/Cotellic in the dust.
Pfizer has seven immuno-oncology drugs in the clinic and an ambition to be the first drug maker to bring a PD-1/OX40/4-1BB triplet regimen into the clinic late this year or early next.
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.