Accelerated FDA approval for Alunbrig in first-line setting for rare and serious form of lung cancer

The US Food and Drug Administration has approved Alunbrig (brigatinib) for adult patients with anaplastic lymphoma kinase-positive (ALK+) metastatic non-small cell lung cancer (NSCLC) as detected by an FDA-approved test, said Japanese pharma giant Takeda (TYO) 4502) on Friday.

This approval, which follows the priority review granted for the supplemental New Drug Application (sNDA) in February, expands Alunbrig’s current indication to include the first-line setting. Alunbrig is a potent and selective next-generation tyrosine kinase inhibitor (TKI) designed to target ALK molecular alterations. The approval comes about four weeks before the company’s Prescription Drug User Fee Act (PDUFA) date of June 23, 2020.

As a frontline lung cancer drug, Alunbrig will compete with Novartis’ (NOVN: VX) Zykadia (ceritinib) and Roche’s (ROG: SIX) Alecensa (alectinib). For the fiscal year ended March 31, 2020, Alunbrig generated sales of 7.2 billion yen (~$67 million), a year-on-year increase of 39%.