FDA has granted Breakthrough Therapy Designation to mobocertinib (TAK-788) for the treatment of patients with metastatic non-small cell lung cancer with epidermal growth factor receptor exon 20 insertion mutations, whose disease has progressed on or after platinum-based chemotherapy.
Mobocertinib is sponsored by Takeda Pharmaceutical Company Ltd.
There are no approved therapies designed to treat this specific form of NSCLC. Mobocertinib is a small-molecule tyrosine kinase inhibitor designed to selectively target EGFR and human EGFR 2 exon 20 insertion mutations.
The Breakthrough Therapy Designation is based on the overall response rate and the long-term benefit seen in patients who responded in a phase I/II study evaluating the safety and efficacy of mobocertinib in patients with locally advanced or metastatic NSCLC whose tumors harbor EGFR exon 20 insertion mutations and have been previously treated with systemic chemotherapy.
“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, lung cancer patient, advocate, and co-founder of the EGFR Resisters, said in a statement.
Takeda presented development of mobocertinib, including the first public disclosure of the structure, during the American Association for Cancer Research virtual annual meeting I, April 28.
