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AstraZeneca, Daiichi Sankyo's Enhertu Gets FDA Breakthrough Status in HER2-Mutated Lung Cancer

NEW YORK – The US Food and Drug Administration has granted AstraZeneca and Daiichi Sankyo's fam-trastuzumab deruxtecan-nxki (Enhertu) breakthrough therapy designation as a treatment for HER2-mutated, metastatic non-small cell lung cancer that has progressed after platinum-based therapy. 

Between 2 percent and 4 percent of NSCLC patients harbor a HER2 mutation in their tumors. Although targeted treatments and immunotherapies have improved outcomes in lung cancer patients, "there remains an unmet medical need for patients with HER2 mutations who are not benefiting from such therapies or for those whose cancer continues to progress," José Baselga, executive VP of R&D Oncology at AstraZeneca, said in a statement.

The agency granted breakthrough therapy designation to the antibody-drug conjugate based on data from the ongoing Phase II DESTINY-Lung01 trial. Interim findings from this trial will be presented at the American Society of Clinical Oncology virtual annual meeting later this month.

Last week, the FDA granted breakthrough therapy designation for the agent as a treatment for HER2-positive, advanced gastric or gastroesophageal junction cancer patients who have had two or more regimens containing trastuzumab (Genentech's Herceptin). The drug is already approved in the US as a treatment for HER2-positive, unresectable or metastatic breast cancer patients who have had two or more prior anti-HER2 breast cancer treatments. Japanese regulators recently granted the drug early conditional approval in this same indication.