Posted by Michael Wonder on 27 Apr 2020
Takeda announces U.S. FDA breakthrough therapy designation for mobocertinib (TAK-788) for the treatment of NSCLC patients with EGFR exon 20 insertion mutations
27 April 2020 - Designation represents positive progress for a unique patient population in need of targeted therapy options.
Takeda today announced that the U.S. FDA granted breakthrough therapy designation for its investigational drug mobocertinib (TAK-788) for the treatment of 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. There are currently no approved therapies designed to treat this specific form of NSCLC.
The breakthrough therapy designation is based on the overall response rate and the long-term benefit seen in patients who responded in a Phase 1/2 study evaluating the safety and efficacy of mobocertinib in patients with locally advanced or metastatic NSCLC whose tumours harbour EGFR exon 20 insertion mutations and have been previously treated with systemic chemotherapy.
