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FDA Approves Takeda's Exkivity With Thermo Fisher CDx for EGFR Exon20 Insertion-Positive NSCLC

NEW YORK – The US Food and Drug Administration on Wednesday granted accelerated approval to Takeda Pharmaceutical's mobocertinib (Exkivity) for previously treated, metastatic non-small cell lung cancers harboring EGFR exon20 insertion mutations.

The agency simultaneously approved Thermo Fisher Scientific's Oncomine Dx Target Test, a next-generation sequencing test that evaluates 23 genes associated with lung cancer, as a companion diagnostic to identify patients whose tumors harbor EGFR exon20 insertion mutations.

The FDA approved mobocertinib based on its activity in a 114-patient cohort in a Phase I/II trial. Among these patients, all of whom harbored EGFR Exon20 insertion mutations and had prior platinum-based therapy, the objective response rate was 28 percent; the median duration of response was 17.5 months; the median overall survival was 24 months; and the median progression-free survival was 7.3 months.

The agency's decision comes roughly a month earlier than originally anticipated. In April, when the FDA accepted Takeda's new drug application for mobocertinib, the company had projected a regulatory decision by Oct. 26.

"Exkivity is the first and only oral therapy specifically designed to target EGFR Exon20 insertions," Teresa Bitetti, Takeda's global oncology business unit president, said in a statement. "We are particularly encouraged by the duration of the responses observed with a median of approximately 1.5 years."

Around 2 percent of NSCLC patients harbor EGFR Exon20 insertion mutations. NSCLC patients with these mutations tend to have a worse prognosis than patients whose tumors are driven by other more common types of EGFR mutations and don't respond well to EGFR inhibitors or chemotherapy.

Since the FDA granted accelerated approval to mobocertinib, Takeda will need to submit confirmatory data on the drug's safety and efficacy in order to receive full approval for the therapy.