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FDA Accepts Takeda's NDA for EGFR Exon20 Insertion-Mutated NSCLC Treatment

NEW YORK – Takeda said on Tuesday that the US Food and Drug Administration has accepted its new drug application for the tyrosine kinase inhibitor mobocertinib as a treatment for previously treated, metastatic non-small cell lung cancers harboring EGFR exon20 insertion mutations.

The FDA has granted the application priority review and is slated to decide whether to grant mobocertinib accelerated approval by Oct. 26.

In its NDA, Takeda submitted data from a Phase I/II trial cohort, in which among 114 EGFR exon20 insertion-mutated metastatic NSCLC patients previously treated with platinum-based chemotherapy, 28 percent had an objective response to mobocertinib as assessed by an independent review committee. As of January 2021, the median duration of response among these patients was 17.5 months and the median progression-free survival was 7.3 months.

"Patients with EGFR exon20 insertion-positive metastatic NSCLC face considerable challenges, as current treatment options provide limited benefit," Christopher Arendt, Takeda's oncology therapeutic area unit head, said in a statement. "We are excited to be one step closer to offering mobocertinib as an effective oral therapy for NSCLC patients with EGFR exon20 insertions that have received prior platinum-based chemotherapy and look forward to continuing conversations with regulatory agencies in the US and around the globe."