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

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

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

Shots: Shots:

  • 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

Tuba Khan

Tuba Khan is Senior Editor at PharmaShots. She is curious, creative, and passionate about recent updates and innovation in the Life sciences industry. She covers Biopharma, MedTech, and Digital health segments. Tuba also has an experience of digital and social media marketing and runs the campaigns independently. She can be contacted on tuba@pharmashots.com

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