Takeda scores new FDA nod for tough-to-treat cancer

Sept. 16, 2021

Takeda has won an FDA approval for a drug that treats a niche cancer.

This week, Japanese drugmaker Takeda announced that Exkivity has been given a conditional approval for patients with advanced non-small cell lung cancer (NSCLC) with EGFR exon 20 insertion mutations. Specifically, the first-in-class oral tyrosine kinase inhibitor (TKI) is now indicated for patients who have progressed on or after platinum-based chemotherapy.

After racking up a number of helpful FDA designations — including Fast Track and an Orphan Drug Designation — Takeda said that Exkivity has become the first approved oral therapy that targets EGFR exon 20 insertion mutations, which are generally resistant to treatments. 

Although NSCLC is the most common type of lung cancer, only about 1-2% of those patients have EGFR exon 20 insertion mutations. Takeda said that the current standards of care — including chemotherapy and other EGFR TKI inhibitors — don’t provide much benefit to this group of patients.