FDA Grants Accelerated Approval to Enhertu for Subgroup of Patients With Unresectable or Metastatic Non-Small Cell Lung Cancer

The FDA’s approval of Enhertu marks the first approval of a drug for patients with HER2-mutant unresectable or metastatic non-small cell lung cancer.

The Food and Drug Administration (FDA) on Thursday granted an accelerated approval to Enhertu (fam-trastuzumab deruxtecan-nxki) for the treatment of adults with unresectable or metastatic non-small cell lung cancer whose tumors express human epidermal growth factor receptor 2 HER2 (ERBB2) mutations, according to a press release from the agency.

The FDA’s approval of Enhertu is indicated for patients who have received a prior systemic therapy and it marks the FDA’s first approval of a drug for patients HER2-mutated non-small cell lung cancer.

The FDA based its decision to approve Enhertu on findings from the DESTINY-Lung02 trial, which has demonstrated that treatment with Enhertu among 52 patients elicited an objective response rate (percentage of patients whose disease partially or completely responded to therapy) of 58%. Moreover, the findings showed that the use of Enhertu resulted in a duration of response (length of time a tumor responds to treatment without growing or spreading) of 8.7 months.

Findings from the study showed that the most common side effects associated with treatment with Enhertu included, but were not limited to, nausea, fatigue, constipation, decreased appetite, vomiting and alopecia.

There is a Boxed Warning associated with the approved indication of Enhertu advising medical professionals of the risk for interstitial lung disease, which is a large group of disorders that may cause progressive scarring of lung tissue and eventually affect a person’s ability to breathe and get enough oxygen into their bloodstream.

Enhertu was analyzed across multiple trials at a 6.4 mg/kg dose in 152 patients with HER2-mutated metastatic non-small cell lung cancer, as well as a dose of 5.4 mg/kg in 102 adults. The release from the FDA stated that increased rates of interstitial lung disease and pneumonitis occurred more frequently in the group of patients who received the higher dose of Enhertu. This approval of Enhertu is indicated at the lower dose of 5.4 mg/kg.

Of note, an accelerated approval is given by the FDA based on surrogate endpoints that permits earlier approval of a drug to treat disease and that would fill an unmet need. A surrogate endpoint, according to information of the FDA’s website, predicts potential clinical benefit.

Drug companies granted an accelerated approval must continue to investigate the drug and confirm anticipated clinical benefit to receive a full approval.

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