The FDA Oncology Center of Excellence published its 2023 annual report.
Jessica Zeller was named director of the Office of Compliance and Enforcement at the FDA Center for Tobacco Products.
FDA OCE annual report lists 83 cancer therapeutic approvals in 2023
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FDA has granted a traditional approval to pembrolizumab (Keytruda) or pembrolizumab and berahyaluronidase alfa-pmph (Keytruda Qlex) for adult and pediatric patients with unresectable or metastatic tumor mutational burden-high [≥13 mutations/megabase] solid tumors, as determined by an FDA-authorized test, that have progressed following prior treatment and who have no satisfactory alternative treatment options.
FDA has approved Hibsago (bepirovirsen) for the treatment of chronic hepatitis B virus infection in combination with nucleos(t)ide analogue reverse transcriptase inhibitor therapy in adult patients without cirrhosis, receiving Nrtl therapy for at least 6 months, who have suppressed HBV deoxyribonucleic acid, and with hepatitis B virus surface antigen levels ≤3000 IU/ml, as determined by an FDA-authorized test.
FDA has cleared TumorSight Risk, an AI-powered, MRI-derived prognostic tool for assessing breast cancer recurrence risk.
FDA has granted the Breakthrough Device designation to Natera Inc.’s multi-cancer early detection assay. The BDD is designed for novel technologies that could enable more effective diagnosis, treatment of life-threatening, or irreversibly debilitating diseases or conditions.
FDA announced the Rare Disease Framework Initiative to reimagine the development of drugs and biologics for rare diseases.
