Novartis said FDA has accepted the company's Biologics License Application filing and granted priority review for CTL019 (tisagenlecleucel-T), an investigational chimeric antigen receptor T cell therapy, in relapsed and refractory pediatric and young adult patients with B-cell acute lymphoblastic leukemia.
BMS and Foundation Medicine announced a collaboration that leverages Foundation Medicine's comprehensive genomic profiling and molecular information solutions to identify predictive biomarkers such as Tumor Mutational Burden and Microsatellite Instability in patients enrolled across clinical trials investigating Bristol-Myers Squibb's cancer immunotherapies.
AbbVie and M2Gen said AbbVie has joined the Oncology Research Information Exchange Network Avatar Research Program.
FDA granted an accelerated approval to Bavencio (avelumab) for the treatment of patients 12 years and older with metastatic Merkel cell carcinoma.
FDA granted an accelerated approval to Bavencio (avelumab) for the treatment of patients 12 years and older with metastatic Merkel cell carcinoma.
FDA approved Kisqali (ribociclib, formerly known as LEE011) in combination with an aromatase inhibitor as initial endocrine-based therapy for treatment of postmenopausal women with hormone receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) advanced or metastatic breast cancer.
FDA granted an accelerated approval to Keytruda (pembrolizumab) for the treatment of adult and pediatric patients with refractory classical Hodgkin lymphoma (cHL), or those who have relapsed after three or more prior lines of therapy.
FDA extended the action date for the supplemental Biologics License Application for Keytruda (pembrolizumab) for previously treated patients with advanced microsatellite instability-high cancer.
Mylan N.V. announced that the company has agreed to the terms of a global settlement with Genentech, Inc. and F. Hoffmann-La Roche Ltd. in relation to patents for Herceptin (trastuzumab), which provides Mylan with global licenses for its trastuzumab product.
Oncoceutics Inc. announced research collaborations with various groups within the NIH to study DRD2 as a novel therapeutic target in oncology.
