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.
FDA has approved Onureg (azacitidine 300 mg tablets, CC-486) for the continued treatment of adult patients with acute myeloid leukemia who achieved first complete remission, or CR with incomplete blood count recovery, following intensive induction chemotherapy and who are not able to complete intensive curative therapy.
FDA has approved Kyprolis (carfilzomib) and Darzalex (daratumumab) in combination with dexamethasone for adult patients with relapsed or refractory multiple myeloma who have received one to three lines of therapy.
Blenrep (belantamab mafodotin-blmf) has received FDA approval as a monotherapy treatment for adult patients with relapsed or refractory multiple myeloma who have received at least four prior therapies including an anti-CD38 monoclonal antibody, a proteasome inhibitor and an immunomodulatory agent.
Guardant360 CDx assay is the first liquid biopsy companion diagnostic test that uses next-generation sequencing technology to receive FDA approval. The assay uses NGS technology to identify patients with specific types of mutations of the epidermal growth factor receptor gene in a deadly form of metastatic non-small cell lung cancer.
The ClonoSEQ assay received expanded FDA clearance to detect and monitor minimal residual disease in blood or bone marrow from patients with chronic lymphocytic leukemia.
