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The US FDA Grants Priority Review to Takeda's Mobocertinib (TAK-788) for EGFR Exon20 Insertion+ Metastatic Non-Small Cell Lung Cancer

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The US FDA Grants Priority Review to Takeda's Mobocertinib (TAK-788) for EGFR Exon20 Insertion+ Metastatic Non-Small Cell Lung Cancer

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  • The US FDA has granted PR for mobocertinib’s NDA to treat adult patients with EGFR Exon20 insertion+ mNSCLC- as detected by an FDA-approved test- who have received prior Pt-based CT. The anticipated PDUFA date is Oct 26- 2021
  • The NDA is based on a P-I/II study assessing mobocertinib (PO) in patients with mNSCLC. The NDA was submitted under the FDA’s accelerated approval program while the review is being conducted under Project Orbis
  • Mobocertinib is a TKI inhibitor designed to selectively target EGFR Exon20 insertion mutations. Additionally- Takeda has established an EAP for patients in the US who may be eligible to receive access to mobocertinib during the review of the NDA

  Ref: Takeda | Image:Takeda

Click here to­ read the full press release 

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