FDA grants Mobocertinib Breakthrough Therapy Designation in NSCLC designation

Share on facebook
Share on twitter
Share on linkedin
Share on email
Share on print

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.

Table of Contents

YOU MAY BE INTERESTED IN

Candace S. Johnson leads America’s oldest cancer research center and Jonathan W. Friedberg leads the newest NCI-designated center. Their catchment areas are contiguous, their faculty and staff members collaborate often, and together their institutions embody the culture of NCI-designated cancer centers. 

In the first meeting of the National Cancer Advisory Board since the inauguration of President Donald Trump, NCI Principal Deputy Director Douglas R. Lowy addressed many of the burning questions the oncology field has for the institute. On indirect costs: NCI will continue to use previously negotiated and approved indirect cost rates, with the exception...

The Cancer Letter staff were finalists for nine 2025 Dateline Awards from the Washington, D.C. Chapter of the Society of Professional Journalists—seven for journalism; two for design—and won first place for four. The Cancer Letter’s entries recognized by SPJ include investigative journalism, series, breaking news, features, photojournalism, commentary, illustration, and front page design. This is...

Never miss an issue!

Get alerts for our award-winning coverage in your inbox.

Login