The antibody drug conjugate, previously approved for HR+ HER2- breast cancer, is also now indicated for certain previously treated EGFR-mutated NSCLC patients.
The FDA has granted accelerated approval to datopotamab deruxtecan-dlnk for certain patients with locally-advanced or metastatic epidermal growth factor receptor -mutatedThe approval marks the second for the antibody drug conjugate, which was discovered by Daiichi Sankyo and is being jointly developed with AstraZeneca.
Initial approval was granted in January for previously treated patients with unresectable or metastatic HR-positive,The new approval was based on efficacy demonstrated in a pooled subgroup of 114 patients treated with datopotamab deruxtecan in thetrials. The confirmed overall response rate among the patients was 45%, and the median duration of response was 6.5 months. Patients in the two trials were treated at the recommended dose of 6 mg/kg, up to a maximum of 540 mg for patients weighing 90 kg or more, given as an intravenous infusion once every 3 weeks until disease progression or unacceptable toxicity. Last year, AstraZeneca voluntarily withdrew its marketing authorization application with the EU's medicines regulator for the antibody drug conjugate for the treatment of adult patients with locally advanced or metastatic nonsquamous non-small cell lung cancer based on the TROPION-Lung01 phase 3 trial. The decision “was informed by feedback from the Committee for Medicinal Products for Human Use of the European Medicines Agency,” the drug company saidthat data from TROPION-Lung01 “has repeatedly knocked shares, most recently in September when results showed that the drug did not significantly improve overall survival results for patients.”Sharon Worcester, MA, is an award-winning medical journalist based in Birmingham, Alabama, writing for Medscape, MDedge, and other affiliate sites. She currently covers oncology, but she has also written on a variety of other medical specialties and healthcare topics. She can be reached atComments on Medscape are moderated and should be professional in tone and on topic. You must declare any conflicts of interest related to your comments and responses. Please see our
Lung Carcinoma Cancer Of The Lung Non-Small Cell Lung Cancer NSCLC Non-Small Cell Lung Cancer (NSCLC) Genomics Genomic Medicine Breast Cancer Malignant Breast Neoplasm Breast Carcinoma Epidermal Growth Factor Receptor EGFR Epidermal Growth Factor Receptor (EGFR) Biologic Therapy Biologics HER2 Negative Breast Cancer HER2- Breast Cancer Antibody Drug Conjugates Adcs
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