FDA accepts Takeda's mobocertinib for priority review

The US Food and Drug Administration has granted priority review for the company’s New Drug Application (NDA) for mobocertinib (TAK-788), Japan’s largest drugmaker Takeda Pharmaceutical (TYO: 4502) announced today.

The drug candidate is intended for the treatment of adult patients with epidermal growth factor receptor (EGFR) Exon20 insertion mutation-positive (insertion+) metastatic non-small cell lung cancer (mNSCLC), as detected by an FDA-approved test, who have received prior platinum-based chemotherapy. Mobocertinib is the first oral therapy specifically designed to selectively target EGFR Exon20 insertion mutations.

The FDA has set a Prescription Drug User Fee Act (PDUFA) target actions date for mobocertinib of October 26, 2021.