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Takeda's Mobocertinib (TAK-788) Receives the US FDA's Breakthrough Therapy Designation for NSCLC Patients with EGFR Exon 20 Insertion Mutations

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Takeda's Mobocertinib (TAK-788) Receives the US FDA's Breakthrough Therapy Designation for NSCLC Patients with EGFR Exon 20 Insertion Mutations

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  • The BT designation is based on P-I/II study assessing the safety and efficacy of mobocertinib (160mg- qd) in patients with LA/ m NSCLC- harboring EGFR exon 20 insertion mutations- prior treated with systemic CT
  • The P-I/II ongoing study results: mPFS (7.3mos.); ORR (43%); safety profile was manageable. The mobocertinib development program began in the NSCLC population and is expected to expand to additional underserved populations in other tumor types
  • Mobocertinib is a potent- small-molecule TKI- designed to selectively target EGFR and HER2 exon 20 insertion mutations and has received the US FDA’s ODD in 2019

Click here ­to­ read full press release/ article | Ref: Takeda  | Image: The Malaysian Reserve


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