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# Takeda Pharma ‘Breakthrough’ Status for Mobocertinib
- URL: https://www.fdaweb.com/takeda-pharma-breakthrough-status-for-mobocertinib/
- Published: 2020-04-28T12:00:00.000Z
- Updated: 2026-09-14T16:12:48.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5146672

FDA has granted Takeda Pharmaceutical a breakthrough therapy designation for its investigational drug mobocertinib (TAK-788) for treating patients with 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 a small-molecule tyrosine kinase inhibitor designed to selectively target EGFR and human EGFR 2 exon 20 insertion mutations, the company says.

The designation is based on the overall response rate and the long-term benefit seen in patients who responded in a Phase 1/2 study. Results showed that mobocertinib treatment was associated with a median progression-free survival of 7.3 months and a confirmed overall response rate of 43% in patients with locally advanced or metastatic EGFR exon 20 insertion-mutant NSCLC, Takeda says. Its safety profile was “manageable,” it says, adding that the most common treatment-related adverse events were diarrhea (85%), nausea (43%), rash (36%), vomiting (29%) and decreased appetite (25%).