FDA July 23 extended the review period for the Biologics License Application for Blenrep (belantamab mafodotin-blmf) combinations for the treatment of patients with relapsed or refractory multiple myeloma who have received at least one prior line of therapy.
FDA issued a Complete Response Letter regarding the Biologics License Application for RP1 (vusolimogene oderparepvec) in combination with nivolumab for the treatment of advanced melanoma.
FDA granted Breakthrough Therapy designation to elironrasib, a RAS(ON) G12C-selective inhibitor, for the treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer who have received prior chemotherapy and immunotherapy but have not been previously treated with a KRAS G12C inhibitor.
The European Commission has approved Cabometyx (cabozantinib) for adult patients with unresectable or metastatic, well differentiated pancreatic and extra-pancreatic neuroendocrine tumors who have progressed following at least one prior systemic therapy other than somatostatin analogues.
European Medicines Agency has granted Orphan Drug designation to ICT01, a humanized anti-butyrophilin 3A monoclonal antibody designed to selectively activate γ9δ2 T cells, for the treatment of acute myeloid leukemia. AML has high unmet medical need and limited treatment options for older or unfit patients who are not eligible for intensive chemotherapy.
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.
