Enhertu sBLA accepted for priority review by FDA

The US Food and Drug Administration has accepted the supplemental Biologics License Application (sBLA) for Enhertu (trastuzumab deruxtecan) for the treatment of adult patients in the USA with unresectable or metastatic non-small cell lung cancer (NSCLC) whose tumors have a HER2 (ERBB2) mutation and who have received a prior systemic therapy. The application has also been granted Priority Review.

Enhertu is a HER2-directed antibody drug conjugate (ADC) being jointly developed by Anglo-Swedish pharma major AstraZeneca (LSE: AZN) and Japan’s Daiichi Sankyo (TYO: 4568) and is forecast by some analysts to have the potential for peak sales of $7 billion. In January, the FDA also accepted an sBLA for the drug in unresectable or metastatic HER2-positive breast cancer who have received a prior anti-HER2-based regimen for priority review.

The FDA grants Priority Review to applications for medicines that, if approved, would offer significant improvements over available options by demonstrating safety or efficacy improvements, preventing serious conditions, or enhancing patient compliance. The Prescription Drug User Fee Act (PDUFA) date, the FDA action date for their regulatory decision, is during the third quarter of 2022. The Priority Review follows  Breakthrough Therapy Designation granted by the FDA for Enhertu in this cancer type in May 2020.