Trastuzumab deruxtecan (Enhertu, T-DXd) is a treatment for breast cancer, advanced stomach cancer, non-small cell lung cancer, and solid tumors. Includes side effects, FDA approval, package insert, and more.
The US Food and Drug Administration (FDA) has granted standard approval to fam-trastuzumab deruxtecan-nxki (Enhertu) for patients with unresectable or metastatic HER2-positivebreast cancerwho have received one prior anti-HER2 therapy. Thisstandard approvalconverts a December 2019accelerated approvalfor...
The FDA has granted an accelerated approval to fam-trastuzumab deruxtecan-nxki (Enhertu) for the treatment of adult patients with unresectable or metastatic HER2-positive breast cancer who have received ≥2 prior anti–HER2-based regimens in the metastatic setting. The FDA has granted an accelera...
FDA approval summary: tucatinib for the treatment of patients with advanced or metastatic HER2-positive breast cancer. Clin. Cancer Res. 27, 1220–1226 (2021). Article CAS PubMed Google Scholar Curigliano, G. et al. Tucatinib versus placebo added to trastuzumab and capecitabine for patients ...
. Later, it was re-approved by the U.S. FDA in September 2017, after studies indicating that a low divided dose (3 mg/m2) of the drug was effective with minimal hepatotoxicity (Norsworthy et al., 2018). The second ADC approved, in 2011 (by an “accelerated approval” process), was...
FDA approval summary: tucatinib for the treatment of patients with advanced or metastatic HER2-positive breast cancer. Clin. Cancer Res. 27, 1220–1226 (2021). Article CAS PubMed Google Scholar Curigliano, G. et al. Tucatinib versus placebo added to trastuzumab and capecitabine for patients ...
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances. Medical Disclaimer Drug Status AvailabilityPrescription onlyRx CSA Schedule* Not a controlled drug N/A Approval History Drug history at FDA...
5 These data led to an updated NCCN recommendation for T-DXd as the preferred second-line therapy with category one evidence, and on May 4th, 2022, the FDA granted regular approval in this setting, making this a new standard second-line therapy for HER2+ MBC. T-DXd represents an ...
Unresectable or metastatic non-small cell lung cancer (NSCLC) whose tumors have activating HER2 (ERBB2) mutations, as detected by an FDA-approved test, and who have received a prior systemic therapy This indication is approved under accelerated approval based on objective response rate and d...
FDA approval for Enhertu was based on the results of a multicenter, single-arm, clinical trial, DESTINY-Breast01 (NCT03248492), that enrolled 184 female patients with HER2-positive, unresectable and/or metastatic breast cancer who had received two or more prior anti-HER2 therapies in the metas...