FDA Accepts sBLA of Enhertu to Treat Metastatic Lung Cancer

The PDUFA date for Enhertu in the lung cancer indication is in the third quarter of 2022.

The FDA has accepted for review the supplemental biologics license application (sBLA) of Enhertu (fam-trastuzumab deruxtecan-nxki) for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have a HER2 mutation. The application has also been granted priority review.

The Prescription Drug User Fee Act (PDUFA) date is during the third quarter of the 2022.

Enhertu is an antibody drug conjugate being jointly developed by Daiichi Sankyo and AstraZeneca. It is currently approved to treat patients with metastatic HER2 positive breast cancer and HER2 positive gastric or gastroesophageal junction adenocarcinoma.

“If approved, ENHERTU has the potential to become a new standard treatment in this patient population, offering a much-needed option for patients with HER2 mutant metastatic non-small cell lung cancer who currently have no targeted treatment options,” Susan Galbraith, MBBChir, Ph.D., executive vice president, oncology R&D, AstraZeneca, said in a press release.

The sBLA is based on data from the pivotal DESTINY-Lung01 phase 2 trial published in January 2022 in The New England Journal of Medicine and is supported by the phase 1 trial published in Cancer Discovery.

In the DESTINY-Lung01 trial, an objective response rate of 54.9% was as assessed by independent central review. The median progression-free survival was 8.2 months and the median overall survival was 17.8 months. The most common drug-related treatment-emergent adverse events were neutropenia, anemia, nausea, fatigue, leukopenia, diarrhea and vomiting.

Lung cancer is the second most common form of cancer globally. In the United States, lung cancer is the second most commonly diagnosed cancer, with more than 236,000 new cases expected in 2022. For patients with metastatic NSCLC, prognosis is poor and only about 8% will live beyond five years after diagnosis.

Enhertu is also being studied as a nonotherapy across multiple HER2 cancers including breast, gastric, lung and colorectal cancers. Trials in combination with other anticancer treatments, such as immunotherapy, are also under way.