FDA grants Priority Review for Alunbrig sNDA

The US Food and Drug Administration has granted priority review for the supplemental New Drug Application (sNDA) to expand the use of Alunbrig (brigatinib) as a first-line treatment for patients with anaplastic lymphoma kinase-positive (ALK+) metastatic non-small cell lung cancer (NSCLC) as detected by an FDA-approved test.

Following the announcement by Takeda (TYO: 4502) today, shares of the Japanese drug major fell 3.8% to 4,067 yen, but market reaction was due to the massive global sell-off relating the coronavirus (COVID-19) epidemic and the fall was far less than other leading domestic drugmakers.

Alunbrig is a next-generation tyrosine kinase inhibitor (TKI) that was designed to target and inhibit ALK genetic alterations. The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of June 23, 2020, for a decision.