SpringWorks Hopes Pediatric Plus Adult Data Make Mirdametinib Go-To For NF1-PN
The company plans to file for FDA approval in the first half of 2024 as it eyes a market of about 40,000 adult and pediatric patients in the US.
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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.
The German drug maker is spending CHF450m to acquire T3, which is focused on developing live bacteria to treat cancers.
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