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Priority Review Granted by FDA for Mobocertinib in Subtype of NSCLC

By: JNCCN 360 Staff
Posted: Tuesday, May 4, 2021

On April 28, Takeda Pharmaceutical Company Limited announced that the U.S. Food and Drug Administration (FDA) has granted Priority Review for the company’s new drug application for mobocertinib (TAK-788) for the treatment of adults with EGFR exon 20 insertion mutation–positive metastatic non–small cell lung cancer (NSCLC) who have received prior platinum-based chemotherapy. This first-in-class oral tyrosine kinase inhibitor is specifically designed to selectively target EGFR exon 20 insertion mutations. The FDA is expected to make a decision on this application by October 26.

An ongoing phase I/II trial is evaluating the antitumor activity and safety of oral mobocertinib in 114 patients with this subtype of NSCLC. The phase I dose-escalation phase is evaluating this agent as a monotherapy and in combination with chemotherapy. They received 160 mg of mobocertinib once daily.



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