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.
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).
FDA accepted the supplemental New Drug Application for Cresemba (isavuconazonium sulfate), a prodrug of isavuconazole, an azole antifungal drug, seeking approval for the treatment of invasive aspergillosis or invasive mucormycosis in pediatric patients aged one to 17 years old.
C2i Genomics and the Tel Aviv Sourasky Medical Center (Ichilov) entered into a strategic collaboration to provide precision oncology clinical testing using C2inform, C2i Genomics’s whole genome minimal residual disease test to improve cancer detection and monitoring nationwide.
FDA has approved Jemperli (dostarlimab-gxly) with carboplatin and paclitaxel, followed by single-agent dostarlimab-gxly, for primary advanced or recurrent endometrial cancer that is mismatch repair deficient, as determined by an FDA-approved test, or microsatellite instability-high.
FDA has approved Lonsurf (trifluridine and tipiracil) with bevacizumab, for metastatic colorectal cancer previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an anti-VEGF biological therapy, and if RAS wild-type, an anti-EGFR therapy.
The European Medicines Agency’s Committee for Medicinal Products for Human Use adopted a positive opinion recommending approval of 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 Committee for Medicinal Products for Human Use of the European Medicines Agency has recommended approval of Opdivo (nivolumab) as a monotherapy for the adjuvant treatment of adults and adolescents 12 years of age and older with completely resected stage 2B or 2C melanoma.
