FDA has granted accelerated approval to linvoseltamab-gcpt, trade name Lynozyfic, a bispecific B-cell maturation antigen-directed CD3 T-cell engager, 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.
REMS for currently approved BCMA- and CD19-directed autologous CAR T-cell immunotherapies eliminated
FDA has determined that a Risk Evaluation and Mitigation Strategy (REMS) is no longer necessary to ensure that the benefits of these CAR T-cell immunotherapies outweigh their risks and to minimize the burden on the healthcare delivery system of complying with the REMS.
FDA granted accelerated approval to datopotamab deruxtecan-dlnk (Datroway) for adults with locally advanced or metastatic epidermal growth factor receptor-mutated non-small cell lung cancer who have received prior EGFR-directed therapy and platinum-based chemotherapy.
FDA has granted Breakthrough Therapy Designation to daraxonrasib, a RAS(ON) multi-selective inhibitor, for previously treated metastatic PDAC in patients with KRAS G12 mutations.
The European Medicines Agency’s Committee for Medicinal Products for Human Use adopted a positive opinion recommending the approval of Sarclisa (isatuximab-irfc) in combination with bortezomib, lenalidomide, and dexamethasone, also called VRd, for the induction treatment of adult patients with newly diagnosed multiple myeloma who are eligible for autologous stem cell transplant. A final decision is expected in the coming months.
The Committee for Medicinal Products for Human Use of the European Medicines Agency has issued a positive opinion for Cabometyx (cabozantinib) for adult patients with unresectable or metastatic, well differentiated extra-pancreatic and pancreatic neuroendocrine tumors who have progressed following at least one prior systemic therapy other than somatostatin analogues.
FDA has approved Zusduri as the first and only FDA-approved medication for adults with recurrent low-grade intermediate-risk non-muscle invasive bladder cancer.
FDA has approved tafasitamab-cxix (Monjuvi, Incyte Corporation) with lenalidomide and rituximab for adults with relapsed or refractory follicular lymphoma.
FDA has approved a new tablet formulation of Brukinsa (zanubrutinib) for all five approved indications. Brukinsa remains the leader in new chronic lymphocytic leukemia patient starts across all lines of therapy in the U.S., and for the first time, has become the overall BTK inhibitor market share leader.
FDA has approved Ibtrozi (taletrectinib) for the treatment of adult patients with locally advanced or metastatic ROS1-positive non-small cell lung cancer.
