FDA has granted Priority Review to TAR-200, an intravesical gemcitabine releasing system, for the treatment of patients with Bacillus Calmette-Guérin-unresponsive high-risk non-muscle invasive bladder cancer with carcinoma in situ, with or without papillary tumors.
Chinese authorities granted the marketing authorization for Braftovi (encorafenib) in combination with cetuximab, for the treatment of adult patients with BRAFV600E-mutant metastatic colorectal cancer, after prior systemic therapy.
Personalis Inc. and Tempus AI Inc. have expanded and extended their strategic collaboration, adding a new indication, colorectal cancer, to the existing, exclusive commercialization agreement.
The National Medical Products Administration in China approved lisaftoclax (APG-2575), a Bcl-2 selective inhibitor, for the treatment of adult patients with chronic lymphocytic leukemia/small lymphocytic lymphoma who have previously received at least one systemic therapy including Bruton’s tyrosine kinase (BTK) inhibitors.
FDA has approved Zegfrovy (sunvozertinib) for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer with epidermal growth factor receptor exon 20 insertion mutations, as detected by an FDA-approved test, whose disease has progressed on or after platinum-based chemotherapy.
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.
