The breakthrough therapy status will allow using of mobocertinib by patients with epidermal growth factor receptor (EGFR) exon 20 insertion mutations whose disease has advanced on or after platinum-based chemotherapy.
Mobocertinib, a small-molecule tyrosine kinase inhibitor (TKI), has been designed to preferentially target EGFR and human EGFR 2 (HER2) exon 20 insertion mutations.
The regular has provided status based on the overall response rate (ORR) and the long-term benefit observed in patients who responded in a phase 1/2 study assessing the safety and efficacy of mobocertinib in patients with locally advanced or metastatic NSCLC whose tumours harbor EGFR exon 20 insertion mutations and were earlier treated with systemic chemotherapy.
According to the company, the ongoing Phase 1/2 trial demonstrated mobocertinib generated a median progression-free survival (PFS) of 7.3 months and a confirmed overall response rate (ORR) of 43%) in patients with locally advanced or metastatic EGFR exon 20 insertion-mutant NSCLC.
Last year, the company secured orphan drug designation from FDA for mobocertinib to treat lung cancer with HER2 mutations or EGFR mutations including exon 20 insertion mutations.
Takeda oncology therapeutic area unit head Christopher Arendt said: “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.
“At Takeda, we are committed to developing novel medicines for hard-to-treat diseases. 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.”
In February this year, Takeda secured priority review for ALUNBRIG (brigatinib) from the FDA for its expanded use as a first-line treatment for a type of NSCLC.