Takeda’s Exkivity Approved by FDA

Takeda Pharmaceutical Company announced FDA approval of Exkivity (mobocertinib) for treatment of patients with a specific form of lung cancer on Sept. 15, 2021. Mobocertinib is intended for patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations whose disease has progressed on or after platinum-based chemotherapy.

Mobocertinib is an oral tyrosine kinase inhibitor specifically designed to selectively target EGFR exon 20 insertion mutations. FDA previously granted it orphan drug designation, breakthrough therapy designation, and fast track designation.

Per the terms of the approval, Exon 20 insertion mutations must be detected by an FDA-approved test. At the same time as mobocertinib was approved, Thermo Fisher Scientific’s Oncomine Dx Target Test was approved. This will serve as a companion diagnostic designed to identify NSCLC patients with EGFR exon 20 insertions.

“The approval of EXKIVITY introduces a new and effective treatment option for patients with EGFR [exon 20] insertion+ NSCLC, fulfilling an urgent need for this difficult-to-treat cancer,” said Teresa Bitetti, president of the Global Oncology Business Unit at Takeda, in a company press release. “EXKIVITY is the first and only oral therapy specifically designed to target EGFR [exon 20] insertions, and we are particularly encouraged by the duration of the responses observed with a median of approximately 1.5 years. This approval milestone reinforces our commitment to meeting the needs of underserved patient populations within the oncology community.”

Source: Takeda