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

April 28, 2021 Auto Bot FDA, Metastatic, Non-Small Cell Lung Cancer, Priority Review, regulatory, Takeda 0

Shots:

  • 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

Click here to­ read full press release/ article | Ref: Takeda | Image: The Hindu Business Line

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