FDA Grants Approval to Trastuzumab Deruxtecan for HER2 Lung Cancer

Lung CancerLung cancer patients now have another treatment option. For those tumors carrying HER2 mutations, can now be treated with trastuzumab deruxtecan. This drug is already approved for use in HER2-positive breast cancer and gastric cancer. Now, it has been approved by the US Food and Drug Administration (FDA) for use in HER2-positive lung cancer. This approval of trastuzumab deruxtecan in non-small cell lung cancer is an important milestone for patients and oncology community. The approval of first HER2-directed treatment option validates HER2 as an actionable target in lung cancer.

Trastuzumab deruxtecan was examined at a dose of 6.4 mg/kg across several trials and as at a dose of 5.4 mg/kg in a randomized dose-finding trial. In 152 patients treated with trastuzumab deruxtecan 5.4mg/kg or 6.4mg/kg, the ORR 57.7% in patients with previously treated unresectable or metastatic non-squamous HER2-mutant NSCLC. The complete response rate observed with trastuzumab deruxtecan was 1.9%. The most common adverse reactions were nausea, decreased white blood cell count, decreased platelet count, increased aspartate aminotransferase, fatigue, decreased appetite etc.

Dave Fredrickson, executive vice president, Oncology Business Unit, AstraZeneca, said in the press release, “HER2-mutant non-small cell lung cancer is an aggressive form of disease which commonly affects young patients who have faced limited treatment options and a poor prognosis to date. Today’s news provides these patients with the opportunity to benefit from a targeted therapy and highlights the importance of testing for predictive markers, including HER2 in lung cancer, at the time of diagnosis to ensure patients receive the most appropriate treatment for their specific disease.”

With this approval, Trastuzumab deruxtecan is now the first HER2-directed therapy approved for patients with previously treated HER2-mutant metastatic non-small cell lung cancer. Also, FDA granted approval to the Oncomine Dx Target Test and Guardant360 CDx as companion diagnostics to detect HER2 mutations in patients with metastatic NSCLC.

The information shared in this blog is for educational purposes only. You should consult your healthcare professional for any medical issues.

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