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All Oncology News

Steven Stein, MD

The European Medicines Agency’s Committee for Medicinal Products for Human Use has issued a positive opinion in favor of granting conditional marketing authorization to the combination of tafasitamab-cxix and lenalidomide, followed by single-agent tafasitamab, for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma who are not candidates for autologous stem cell transplant.

Noah Berkowitz, MD, PhD

The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended that idecabtagene vicleucel receive conditional marketing authorization for use in adult patients with relapsed and refractory multiple myeloma who have received at least 3 prior therapies, including an immunomodulatory agent, a proteasome inhibitor, and a CD38-targeted antibody, and have progressed on their last therapy.

FDA

In a 13 to 4 vote, the FDA’s Oncologic Drugs Advisory Committee chose to hold off on a decision regarding accelerated approval for retifanlimab for the treatment of patients with locally advanced or metastatic squamous carcinoma of the anal canal who have progressed on or are intolerant of platinum-based chemotherapy.

The Chinese National Medical Products Administration has granted conditional approval to olaparib for use as a monotherapy in the treatment in adult patients with germline or somatic BRCA-mutated, metastatic castration-resistant prostate cancer who have progressed after previous treatment that included a new hormonal agent like abiraterone acetate or enzalutamide.