Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. This indication is approved under accelerated approval based on overall response rate and duration of response. In August 2019, FDA granted accelerated approval to entrectinib for people 12 years of age and older for this indication.įDA also approved a new oral pellet formulation for entrectinib, and the prescribing information now includes instructions for making an oral suspension from the capsules. Genentech’s Rozlytrek (entrectinib) was granted accelerated approval from the FDA for young children older than 1 month with solid tumors that have a neurotrophic tyrosine receptor kinase (NTRK) gene fusion without a known acquired resistance mutation, are metastatic or where surgical resection is likely to result in severe morbidity, and have progressed following treatment or have no satisfactory standard therapy. (October 2023)įDA Expands Pediatric Indication for Rozlytrek and Approves New Pellet Formulation ![]() This application was granted priority review, breakthrough designation, and orphan drug designation. The FDA also approved the Abbott RealTime IDH1 Assay as a companion diagnostic device to select people for ivosidenib. The FDA approved Servier Pharmaceuticals’ Tibsovo (ivosidenib) for adults with relapsed or refractory myelodysplastic syndromes (MDS) with a susceptible isocitrate dehydrogenase-1 (IDH1) mutation, as detected by an FDA-approved test. Tibsovo Granted FDA Approval for Myelodysplastic Syndromes This application was granted priority review, breakthrough designation and orphan drug designation. FDA also approved toripalimab-tpzi as a single agent for adults with recurrent unresectable or metastatic NPC with disease progression on or after a platinum-containing chemotherapy. The Food and Drug Administration approved Coherus BioSciences’ LOQTORZ (toripalimab-tpzi) with cisplatin and gemcitabine for the first-line treatment of adults with metastatic or recurrent, locally advanced nasopharyngeal carcinoma (NPC). Food and Drug AdministrationįDA Approves LOQTORZ for Nasopharyngeal Carcinoma ![]() Recent Oncology/Hematology Approvals from the U.S.
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