FDA approved midostaurin, trade name Rydapt, for the treatment of adult patients with newly diagnosed acute myeloid leukemia who are FLT3 mutation-positive, as detected by an FDA-approved test, in combination with standard cytarabine and daunorubicin induction and cytarabine consolidation.
FDA expanded the approved use of Stivarga (regorafinib) to include treatment of patients with hepatocellular carcinoma who have been previously treated with the drug sorafenib. This is the first FDA-approved treatment for a liver cancer in almost a decade.
FDA granted an accelerated approval to brigatinib, trade name Alunbrig, for the treatment of patients with metastatic anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC) who have progressed on or are intolerant to crizotinib.
FDA has posted warning letters addressed to 14 U.S.-based companies illegally selling more than 65 products that fraudulently claim to prevent, diagnose, treat or cure cancer.
DelMar Pharmaceuticals Inc. said it has entered into a three-year collaboration with Duke University to evaluate VAL-083, the company's platform compound, as a front-line treatment for newly diagnosed patients with glioblastoma multiforme.
FDA granted accelerated approval to Genentech's Tecentriq (atezolizumab) for the initial treatment of patients with locally advanced or metastatic urothelial carcinoma who are not eligible for cisplatin chemotherapy.
FDA granted Breakthrough Therapy designation to Novartis's CTL019, an investigational chimeric antigen receptor T cell (CAR-T) therapy, for the treatment of adult patients with relapsed and refractory (r/r) diffuse large B-cell lymphoma who have failed two or more prior therapies.
Health Canada approved via priority review Janssen's Darzalex (daratumumab), in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of patients with multiple myeloma who have received at least one prior therapy.
FDA has removed the Risk Evaluation and Mitigation Strategy requirements for erythropoiesis-stimulating agents in patients with anemia due to associated myelo-suppressive chemotherapy.
The Human Vaccines Project, Vanderbilt University Medical Center and Illumina Inc. are collaborating on a project focused on deciphering the human immunome, the genetic underpinnings of the immune system.
