GSK’s Zejula Wins First-Line Ovarian Cancer Use
FDA Extension Is PARP Inhibitor’s Third Indication In That Disease
Winning an expanded US FDA indication for Zejula as a first-line ovarian cancer treatment further vindicates GSK’s hefty purchase price for Tesaro and sets the scene for more therapeutic extensions for the PARP inhibitor, oncology R&D chief Axel Hoos told Scrip.
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US FDA-approved belantamab mafodotin is indicated for heavily pre-treated multiple myeloma and has a list price of $23,900 per month. Its REMS could limit initial uptake, but response rates have been encouraging.
Oncology R&D head Axel Hoos spoke with Scrip about data at ASCO and the company’s strategy in immuno-oncology, cancer epigenetics, cell and gene therapy and synthetic lethality.
Keeping Track Of US FDA Decisions: Approvals For Ongentys And New Keytruda, Darzalex Dosing, But Not For Trevyent
The latest US FDA approval decision news and highlights from the Pink Sheet’s FDA Performance Tracker