FDA Grants Accelerated Approval to Enhertu for HER2 Mutant Non-small Cell Lung Cancer


The FDA approval of fam-trastuzumab deruxtecan-nxki (Enhertu) to treat HER2 mutant non-small cell lung cancer was based on results from the DESTINY-Lung02 phase 2 trial.

The FDA granted accelerated approval to fam-trastuzumab deruxtecan-nxki (Enhertu; Daiichi Sankyo, Inc) to treat adult patients with unresectable or metastatic non-small cell lung cancer (NSCLC). The approval indication also noted that to be eligible for this treatment, patients with NSCLC must have tumors that activate HER2 (ERBB2) mutations and have had prior systemic therapy.

An antibody drug conjugate (ADC), trastuzumab deruxtecan was developed to treat HER2 specifically, and it was granted accelerated approval after having a successful objective response rate (ORR) and duration of response (DoR) during the DESTINY-Lung02 phase 2 trial.

“The approval of trastuzumab deruxtecan in non-small cell lung cancer is an important milestone for patients and the oncology community,” said Bob T. Li, MD, PhD, MPH, a medical oncologist and physician-scientist at Memorial Sloan Kettering Cancer Center, New York, in a press release.

HER2 mutant non-small cell lung cancer commonly affects young patients, explained Dave Fredrickson, executive vice president, Oncology Business Unit at AstraZeneca, in the press release. With the new approval, patients could have targeted treatment options that were not available to them in the past. Frederickson added that the approval emphasizes the importance of testing predictive markers at diagnosis to provide the most appropriate care for patients.

In the phase 2 DESTINY-Lung02 trial, researchers administered trastuzumab deruxtecan at 5.4 mg/kg. Based on the results, the researchers observed that patients with HER2 mutant unresectable or metastatic non-squamous NSCLC responded to the drug with a 57.7% objective response rate (ORR).

“The availability of ENHERTU as the first HER2 targeted treatment option for HER2 mutant non-small cell lung cancer is great news for patients,” Upal Basu Roy, PhD, MPH, executive director of research at LUNGevity, said in the press release. “We are thrilled to see a novel treatment option available that targets this group of rare mutations in lung cancer. This approval is a great reminder that access to high-quality biomarker testing will be critical to ensuring that patients whose tumors have HER2 mutations have access to these new therapies.”

Within the past 3 years, the FDA approved trastuzumab deruxtecan to treat 3 different types of tumors. After successful results from the phase 2 trial for DESTINY-Lung01, the FDA granted Priority Review and Breakthrough Therapy Designation for DESTINY-Lung02 in 2020.

“We are excited that the FDA has granted accelerated approval for ENHERTU for patients with HER2 mutant metastatic non-small cell lung cancer,” Ken Keller, the global head of oncology business, president, and CEO of Daiichi Sankyo, Inc, said in the press release. “ENHERTU has now been approved in 3 different tumor types, underscoring its significant potential across several HER2 targetable tumors.”


ENHERTU® Approved in the U.S. as the First HER2 Directed Therapy for Patients with Previously Treated HER2 Mutant Metastatic Non-Small Cell Lung Cancer. Tokyo, Japan: Daiichi Sankyo; Aug 11, 2022. Accessed on Aug 12, 2022. https://www.businesswire.com/news/home/20220811005803/en/ENHERTU%C2%AE-Approved-in-the-U.S.-as-the-First-HER2-Directed-Therapy-for-Patients-with-Previously-Treated-HER2-Mutant-Metastatic-Non-Small-Cell-Lung-Cancer

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