Posted by Michael Wonder on 28 Apr 2021
Takeda announces U.S. FDA grants priority review for new drug application for mobocertinib (TAK-788) as a treatment for EGFR exon 20 insertion positive metastatic non-small cell lung cancer
28 April 2021 - Prescription Drug User Fee Act target action date set for 26 October 2021.
Takeda today announced that that the U.S. FDA has granted priority review for the company’s new drug application for mobocertinib (TAK-788) for the treatment of adult patients with epidermal growth factor receptor Exon 20 insertion mutation positive metastatic non-small cell lung cancer, as detected by an FDA-approved test, who have received prior platinum-based chemotherapy.
