The FDA continues to approve new drugs and expand indications for others at a rapid pace. Here’s a summary of what happened last month.
Last month, the US Food and Drug Administration approved two new drugs, expanded the indications for several other agents as well as a diagnostic test, and issued a clinical trial hold on a trial investigating a new immunotherapy agent. to treat certain patients with unresectable or metastatic hormone receptor –positive, human epidermal growth factor receptor 2 –negative breast cancer .
The FDA also granted full approval, following an accelerated approval in 2017, for acalabrutinib in patients with previously treated MCL. Approval was based on findings from the phase 3 DESTINY-Breast06 trial, which showed that among the patients with HER2-low disease, the median progression-free survival was 13.2 months in the trastuzumab deruxtecan group vs 8.1 months in the chemotherapy group . The researchers reported a similar progression-free survival benefit in the exploratory HER2-ultralow population.
The new generic, which is available in 2, 3, and 5 mg, joins a generic version of the oral suspension tablets already on the market from Mylan/Viatris. The approval “increases the supply of an oncology product that has limited suppliers,” Amneal said in its press release.
Malignant Breast Neoplasm Breast Carcinoma U.S. Food And Drug Administration United States Food And Drug Administration FDA Food And Drug Administration (FDA) Food And Drug Administration Biologic Therapy Biologics Malignant Head And Neck Neoplasm Head And Neck Cancer Head And Neck Cancer (HNC) Antineoplastic Drug Anti-Cancer Agents Erlotinib Gefitinib Imatinib
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