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All Oncology News

The FDA has approved a supplemental new drug application for ivosidenib as a single agent for the first-line treatment of adult patients with IDH1-mutant acute myeloid leukemia, as detected by an FDA-approved test, who are ≥75 years old or are ineligible to receive intensive chemotherapy.

The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended that the conditional marketing authorization for olaratumab be revoked following results of the ANNOUNCE study, which did not demonstrate a survival benefit with the PDGFRα antagonist in combination with doxorubicin versus doxorubicin alone in patients with advanced or metastatic soft tissue sarcoma.

The European Medicines Agency's Committee for Medicinal Products for Human Use issued a positive opinion recommending approval of cemiplimab for the treatment of adult patients with metastatic or locally advanced cutaneous squamous cell carcinoma who are not candidates for curative surgery or curative radiation, according to Regeneron Pharmaceuticals, the manufacturer of the PD-1 inhibitor.

A marketing authorization application has been submitted to the European Medicines Agency for luspatercept for the treatment of adult patients with very low- to intermediate-risk myelodysplastic syndrome–associated anemia with ring sideroblasts who require red blood cell transfusions and have not received or are ineligible to receive erythropoiesis-stimulating agents.

The combination of lenalidomide (Revlimid) with rituximab (Rituxan), cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP; R2-CHOP) did not improve progression-free survival compared with placebo and R-CHOP as a frontline therapy in patients with activated B-cell-type diffuse large B-cell lymphoma, missing the primary endpoint of the phase III ROBUST trial.