FDA has placed a partial clinical hold on the initiation of new patients in U.S. studies evaluating magrolimab to treat acute myeloid leukemia.
FDA approved Reblozyl (luspatercept-aamt) for the treatment of anemia without previous erythropoiesis stimulating agent use in adult patients with very low- to intermediate-risk myelodysplastic syndromes who may require regular red blood cell transfusions.
FDA granted 510(k) clearance to AION Biosystems’s iTempShield, a skin-wearable device supported by cloud-based software and proprietary algorithms enables continuous body temperature monitoring.Â
FDA accepted a supplemental New Drug Application and granted Priority Review for Tibsovo (ivosidenib tablets) in the treatment of patients with isocitrate dehydrogenase 1-mutated relapsed or refractory myelodysplastic syndromes. If approved, Tibsovo would be a first-in-class targeted therapy option for MDS patients within this molecularly defined subset.
The European Commission approved Keytruda (pembrolizumab) in combination with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy for the first-line treatment of locally advanced unresectable or metastatic human epidermal growth factor receptor 2-positive gastric or gastroesophageal junction adenocarcinoma in adults whose tumors express PD-L1.
The European Commission approved Opdivo (nivolumab) as a monotherapy for the adjuvant treatment of adults and adolescents 12 years of age and older with stage 2B or 2C melanoma who have undergone complete resection, based upon results from the CheckMate-76K trial.
The European Medicines Agency has accepted for review the Marketing Authorization Application for odronextamab to treat adult patients with relapsed/refractory follicular lymphoma or R/R diffuse large B-cell lymphoma, who have progressed after at least two prior systemic therapies. The EMA previously granted odronextamab Orphan Drug Designation for FL and DLBCL.Â
FDA granted accelerated approval to Talvey (talquetamab-tgvs) for adults with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody.
FDA granted regular approval to Gavreto (pralsetinib) for adult patients with metastatic rearranged during transfection fusion-positive non-small cell lung cancer as detected by an FDA-approved test.
FDA approved the therascreen PDGFRA RGQ PCR kit, a companion diagnostic intended for use to aid clinicians in identifying patients with gastrointestinal stromal tumors who may be eligible for treatment with Ayvakit (avapritinib).Â
