Health Canada has granted approval for Keytruda (pembrolizumab), Merck’s anti-PD-1 therapy, as monotherapy for the adjuvant treatment of adults with renal cell carcinoma at intermediate-high or high risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions.
Eclipse, a venture capital firm investing in the digital transformation of the world’s physical industries, and Mayo Clinic have established and seeded funding for Nucleus RadioPharma, a new company built to ensure cancer patients can access potentially life-saving radiopharmaceuticals by developing technologies to modernize the clinical development, manufacturing, and supply chain of these promising new therapies.
FDA has granted accelerated approval to Lytgobi (futibatinib) for adult patients with previously treated, unresectable, locally advanced or metastatic intrahepatic cholangiocarcinoma harboring fibroblast growth factor receptor 2 gene fusions or other rearrangements.
MD Anderson Cancer Center and ARTIDIS AG have formed a strategic alliance to investigate ARTIDIS technology as a novel treatment-optimization tool for patients with solid tumors in several distinct indications.
Merck, known as MSD outside of the United States and Canada, today announced that Keytruda (pembrolizumab), Merck’s anti-PD-1 therapy, received four new approvals from Japan’s Ministry of Health, Labor and Welfare. The indications included TNBC, renal cell carcinoma, cervical cancer, and melanoma.
FDA has granted regular approval to Retevmo (selpercatinib) adult patients with locally advanced or metastatic solid tumors with a rearranged during transfection (RET) gene fusion that have progressed on or following prior systemic treatment or who have no satisfactory alternative treatment options.
FDA has approved Pedmark to reduce the risk of ototoxicity associated with cisplatin in pediatric patients 1 month and older with localized, non-metastatic solid tumors.
Foundation Medicine Inc., a pioneer in molecular profiling for cancer, and Day One Biopharmaceuticals, a clinical-stage biopharmaceutical company dedicated to developing and commercializing targeted therapies for people with life-threatening diseases, has formed a collaboration to develop FoundationOne CDx as a companion diagnostic for Day One’s lead investigational therapy, DAY101 (tovorafenib).
Researchers from Memorial Sloan Kettering Cancer Center have discovered subclonal co-mutations and immunophenotypic profiles that can distinguish individual cells indicative of future AML relapse from others present after treatment using Mission Bio Inc.’s Tapestri Single-cell Multi-omics Measurable Residual Disease assay.
FDA has issued a safety alert informing patients and providers about reports of squamous cell carcinoma and various lymphomas located in the capsule or scar tissue around breast implants. After an initial extensive review, we currently believe that the risk of SCC and other lymphomas occurring in the tissue around breast implants is rare.
