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Takeda Closes in on Potential Approval for NSCLC Drug, Mobocertinib

(BioSpace) Apr 28, 2021 - Takeda’s non-small cell lung cancer (NSCLC) treatment Mobocertinib (TAK-788) is leading closer to regulatory approval after the U.S. Food and Drug Administration granted priority review to the New Drug Application. The FDA assigned a Prescription Drug User Fee Act (PDUFA) action date for Oct. 26.

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H. Jack West, MD (Posted: May 01, 2021)

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Mobocertinib doesn't offer activity at a level of osimertinib for EGFR mutated NSCLC or alectinib for ALK-positive NSCLC, and it presents some challenges in terms of tolerability, but it fulfills a real unmet need for this patient population. I know I and my patients with advanced NSCLC harboring an EGFR exon 20 insertion mutation would welcome having it approved and commercially available.

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Tomasz M. Beer, MD, FACP

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Dean Gesme, MD

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Debu Tripathy, MD

Professor and Chair, Department of Breast Medical Oncol...

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H. Jack West, MD

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