FDA has accepted and granted priority review to the supplemental New Drug Application for Xalkori for the treatment of pediatric patients with relapsed or refractory systemic anaplastic large cell lymphoma that is anaplastic lymphoma kinase-positive.
The Committee for Medicinal Products for Human Use of the European Medicines Agency has adopted a positive opinion for GSK's Zejula (niraparib) as a first-line maintenance treatment in women with advanced ovarian cancer who responded to platinum-based chemotherapy, regardless of biomarker status.
FDA has granted Rhenium NanoLiposomes Fast Track Designation for the treatment of patients with recurrent glioblastoma.
Elicio Therapeutics and Moffitt Cancer Center are collaborating to characterize combination therapies pairing Elicio's CD19 Amphiphile and a universal FITC Amphiphile with CD19 CAR T cells.
Physicians at the University of California, San Diego School of Medicine and Cofactor Genomics are working to improve the ability to predict tumor response to immunotherapy in recurrent and metastatic squamous cell carcinoma of the head and neck.
Gavreto (pralsetinib) has received an accelerated approval from FDA for adult patients with metastatic RET fusion-positive non-small cell lung cancer, as detected by an FDA-approved test.
The Oncomine Dx Target Test as a companion diagnostic has received FDA approval to identify RET fusion-positive, metastatic non-small cell lung cancer patients who are candidates for Gavreto (pralsetinib), a targeted therapy developed by Blueprint Medicines.
FDA has alerted health care professionals, oncology clinical investigators, and patients that a clinical trial studying the use of atezolizumab (Tecentriq) and paclitaxel in patients with previously untreated inoperable locally advanced or metastatic triple negative breast cancer showed the drug combination did not work to treat the disease.
DetermaRx has received a pricing decision from Centers for Medicare and Medicaid Services.
MD Anderson Cancer Center and Xencor Inc. are working together on investigational treatments for patients with a variety of cancer types. The parties will collaborate to design and execute additional clinical studies with Xencor's portfolio of XmAb drug candidates, including novel bispecific antibodies and engineered cytokines. Xencor is committing to funding and supporting these studies over an initial five-year term.
