April 27, 2020
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FDA grants breakthrough therapy designation to mobocertinib for lung cancer subset

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The FDA granted breakthrough therapy designation to mobocertinib for treatment of certain patients with metastatic non-small cell lung cancer.

The designation applies to use of mobocertinib (TAK-788, Takeda) by patients with EGFR exon 20 insertion mutations whose disease progressed on or after platinum-based chemotherapy.

There are no FDA-approved therapies for this patient population.

Mobocertinib is a small-molecule tyrosine kinase inhibitor designed to selectively target EGFR and human EGFR 2 (HER2) exon 20 insertion mutations.

The FDA based the breakthrough therapy designation on results of a phase 1/phase 2 study that evaluated the efficacy and safety of mobocertinib for patients with locally advanced or metastatic NSCLC whose tumors harbor EGFR exon 20 insertion mutations and who previously received systemic chemotherapy.

“We are pleased that the FDA has recognized the therapeutic potential mobocertinib offers for patients with EGFR exon 20 insertion-mutant NSCLC who are desperately in need of effective treatment options,” Christopher Arendt, PhD, head of the oncology therapeutic unit at Takeda, said in a company-issued press release. “Establishing breakthrough therapy designation for mobocertinib is one step forward in our efforts to help change the current standard of care for this underserved population.”

NSCLC accounts for about 85% of lung cancer cases worldwide; however, only 1% to 2% of patients have EGFR exon 20 insertion mutations.

“Although most EGFR mutations can be targeted by currently available TKIs, people with exon 20 insertion mutations often suffer and feel forgotten since available EGFR inhibitors don’t work well in their cancer,” Jill Feldman, co-founder of EGFR Resisters, a patient-driven advocacy group, said in the release. “We are excited by the potential this treatment has to extend the lives of people who have had no approved treatment options to target their disease.”