Rydapt And Alunbrig Approvals Headline Good Week For Targeted Oncologics At US FDA
After almost 20 years, targeted therapy for oncology is still producing breakthroughs. This week saw two breakthrough-designated novel kinase inhibitor approvals, Novartis' Rydapt (midostaurin) and Takeda's Alunbrig (brigatinib), and breakthrough status for Pfizer's next-generation candidate lorlatinib.
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Keeping Track: Vitaros Reenters The Wilderness, Remoxy Gives It A Fourth Try, And Two Novel Approvals
The latest drug development news and highlights from our US FDA Performance Tracker.
PD-1 inhibitor performance and the intense curiosity around AstraZeneca both for its MYSTIC trial and Soriot's faithfulness to the company are key themes at the half-year mark. Eyes are also on commercial performance for Roche's Ocrevus and Merck's anacetrapib for clarity on whether it has a commercial future.
Novartis’s new kinase inhibitor, Rydapt (midostaurin), for the treatment of AML and mastocytosis, could have got the thumbs up for EU approval in June but the committee that makes the decision, the European Medicines Agency’s CHMP, had concerns about the application. The CHMP has now issued a positive opinion for the orphan drug and formal EU approval is in sight.