Persistence Pays Off With US Approval Of Aveo’s Fotivda In RCC
The approval marks the first commercial launch for Aveo in the US, but tivozanib has shown modest efficacy in cancer and the approval is relegated to later lines.
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US FDA is reviewing confirmatory trial data that suggest a ‘detriment in survival’ with Oncopeptides’ alkylating agent in relapsed/refractory multiple myeloma and may convene its Oncologic Drugs Advisory Committee to explore continued marketing for patients who received at least four prior lines of therapy.
Emerging biopharma companies developed and launched 40% of all new drugs that hit the market in the US in 2020, a significant increase from five years ago, according to IQVIA.
Keeping Track: US FDA Acts On 5 Novel Drugs: Approval For Fotivda, Pepaxto, Azstarys; CRLs For Defencath and Oral Paclitaxel
The latest drug development news and highlights from the Pink Sheet US FDA Performance Tracker