FDA Approves Enhertu for Metastatic Lung Cancer

The FDA has granted accelerated approval for Enhertu (fam-trastuzumab deruxtecan-nxki) to treat adult patients with unresectable or metastatic non-small cell lung cancer (NSCLC) whose tumors have HER2 mutations. Enhertu is an HER2 directed antibody drug conjugate (ADC) being jointly developed and commercialized by Daiichi Sankyo and AstraZeneca.

Bob T. Li, M.D., Ph.D.

“After two decades of research into the role of targeting HER2 in lung cancer, the approval of the first HER2 directed treatment option validates HER2 as an actionable target in lung cancer and marks an important step forward for treating this patient population with unmet medical needs,” Bob T. Li, M.D., Ph.D., medical oncologist and physician-scientist, Memorial Sloan Kettering Cancer Center, New York, said in a press release.

The accelerated approval was based on the results from the DESTINY-Lung02 phase 2 trial. An interim efficacy analysis in a pre-specified patient cohort showed that Enhertu demonstrated a confirmed objective response rate of 57.7% in patients with HER2 mutant unresectable or metastatic non-squamous NSCLC who had received one prior systemic therapy. Complete response was seen in one patient and partial response was seen in 55.8% of patients with a median duration of response of 8.7 months.

Serious adverse reactions in >1% of patients include interstitial lung disease/pneumonitis, thrombocytopenia, dyspnea, nausea, pleural effusion, and increased troponin I. One patient died with suspected interstitial lung disease/pneumonitis. Increased rates of interstitial lung disease/pneumonitis were observed at a higher dose. Enhertu was approved with a boxed warning about interstitial lung disease/pneumonitis and embryo-fetal toxicity.

The FDA also approved Life Technologies’s Oncomine Dx Target Test (tissue) and the Guardant Health’s Guardant360 CDx (plasma) as companion diagnostics for Enhertu.