FDA approved Aucatzyl (obecabtagene autoleucel), a CD19-directed genetically modified autologous T-cell immunotherapy, for adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia.
Tempus AI Inc. announced a collaboration with Flatiron Health, a leading healthtech company dedicated to expanding the possibilities of point of care solutions in oncology, to integrate its comprehensive genomic testing directly into Flatiron’s cloud-based Electronic Medical Record platform, OncoEMR, through the Molecular Profiling Integration.Â
Humana Inc. and Evolent Health Inc. announced an expansion of their strategic medical oncology partnership to modernize and streamline prior authorization processes to include radiation and surgical oncology services.Â
Mainz Biomed, a molecular genetics diagnostic company specializing in the early detection of cancer, announced a collaborative agreement with Thermo Fisher Scientific Inc. through its subsidiary Life Technologies Corporation.
FDA has approved MI Cancer Seek for use as a companion diagnostic to identify patients with cancer who may benefit from treatment with targeted therapies.
Scemblix (asciminib) was granted accelerated approval by FDAÂ for adult patients with newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase.
Pangea Biomed, a startup developing the Enlight cancer response prediction platform, announced the beginning of a pilot collaboration with the Knight Cancer Institute at Oregon Health and Science University.
FDA has approved Vyloy (zolbetuximab-clzb), a claudin 18.2-directed cytolytic antibody, with fluoropyrimidine- and platinum-containing chemotherapy, for the first-line treatment of adults with locally advanced unresectable or metastatic human epidermal growth factor receptor 2-negative gastric or gastroesophageal junction adenocarcinoma whose tumors are CLDN18.2 positive, as determined by an FDA-approved test.
FDA has accepted the New Drug Application for TLX101-CDx (Pixclara), an agent for the imaging of glioma.Â
The European Commission has approved two new indications for Keytruda (pembrolizumab), an anti-PD-1 therapy, in gynecologic cancers.
