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

  Ref: Takeda | Image:Takeda