FDA Accepts NDA for neladalkib in TKI pre-treated advanced ALK-positive NSCLC with Priority Review & PDUFA target action date of Nov 27, 2026
“With today’s announcement, New Drug Applications for both zidesamtinib and neladalkib in TKI pre-treated populations are now under review with the FDA, and TKI-naïve expansion strategies are underway,” said James Porter, Ph.D., Chief Executive Officer of Nuvalent. “Our U.S. commercial and medical affairs teams are in place and focused on establishing the strong foundational systems and infrastructure required to effectively deliver on multiple synergistic launches in biomarker-driven NSCLC.”
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