Another Late-Stage Failure For AstraZeneca's Selumetinib
AstraZeneca's novel targeted anticancer selumetinib has missed its endpoints in a Phase III study in lung cancer, the second late-stage failure for the product, which last year disappointed in uveal melanoma.
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Koselugo (selumetinib) was largely forgotten after failing Phase III trials in thyroid and lung cancer, as well as uveal melanoma, but its approval in Europe for inoperable plexiform neurofibromas in patients with neurofibromatosis type 1, which follows a US approval for the rare condition last year, has breathed new life into the once-lauded MEK 1/2 inhibitor.
Three accelerated assessment requests will either be granted or rejected this week at the European Medicines Agency.
Keeping Track Of User Fee Decisions And Filings: Adakveo, Brukinsa And Fetroja Mark Massive Week Of Novel Approvals
The latest news on US FDA user fee decisions and submissions to the agency.