The OncLive® News page includes the latest in clinical oncology news, including breaking regulatory decisions, clinical trial findings, pivotal and practice-changing data published in academic peer-reviewed journals, and more across solid and hematologic malignancies. Regulatory news includes new drug approvals by the FDA and European Union, priority review and breakthrough therapy designations, and orphan drug and fast track statuses.
FDA Grants Pembrolizumab/Axitinib Combo Priority Review for Frontline RCC
February 15th 2019The FDA has granted a priority review designation to a supplemental biologics license application for the combination of pembrolizumab and axitinib as a frontline treatment for patients with advanced renal cell carcinoma.
Brahmer Calls for Better Incorporation of Precision Medicine in Lung Cancer
February 14th 2019Julie R. Brahmer, MD, discusses advances made with immunotherapy in the lung cancer space, highlights challenges that still need to be addressed, and sheds light on ongoing research designed to determine treatment approaches beyond PD-1/PD-L1 and CTLA-4 inhibition
Consistent Findings Validate Viability of TKI Discontinuation in CML
February 14th 2019First- and second-generation TKIs confer a significant survival benefit for patients with chronic-phase chronic myeloid leukemia (CP-CML)—so much so, that treatment discontinuation has become a viable option for select patients.
FDA Approves Split-Dosing Regimen of Daratumumab for Multiple Myeloma
February 13th 2019The FDA has approved a split-dosing regimen of daratumumab for patients with multiple myeloma, providing physicians the option to split the first infusion of the CD38-directed monoclonal antibody over 2 consecutive days or complete in a single session.
Chao Discusses Impact of RAINBOW, TAGS, and KEYNOTE Trials in Gastric/GEJ Cancer
February 12th 2019The RAINBOW and TAGS trials have demonstrated strong evidence to support the use of ramucirumab and TAS-102 in patients with advanced gastric or gastroesophageal cancer who have progressed on first-line therapy.
FDA Grants Pembrolizumab Priority Review for Frontline HNSCC
February 11th 2019The FDA has granted a priority review designation to a supplemental biologics license application for pembrolizumab (Keytruda) alone or in combination with platinum and 5-fluorouracil chemotherapy as a first-line treatment for patients with recurrent or metastatic head and neck squamous cell carcinoma.
CDK4/6 Inhibitors Changing Course of Care in HR+/HER2- Breast Cancer
February 9th 2019Earlier diagnosis and more effective therapeutic options are enabling physicians to deliver better rates of disease control and improved quality of life to patients with hormone receptor–positive, HER2-negative metastatic breast cancer.
FDA Schedules ODAC Meeting for Selinexor in Penta-Refractory Myeloma
February 8th 2019The FDA has scheduled an Oncologic Drugs Advisory Committee hearing for February 26, 2019, to discuss a new drug application for selinexor in combination with dexamethasone for the treatment of patients with penta-refractory multiple myeloma.
FDA Extends Review Period for Ruxolitinib in GVHD
February 8th 2019The FDA has added 3 months to the review period for a supplemental new drug application for ruxolitinib for the treatment of patients with acute graft-versus-host disease who have had an inadequate response to corticosteroids, making the new action date May 24, 2019.
Study Confirms Long-Term Risk of Secondary Cancers in Pediatric Hodgkin Lymphoma Survivors
February 7th 2019The relative risk of developing a solid subsequent malignant neoplasm remained elevated in survivors of childhood Hodgkin lymphoma, according to extended follow-up of more than 25 years from the Late Effects Study Group cohort.
FDA Approves Caplacizumab-yhdp in Acquired Thrombotic Thrombocytopenic Purpura
February 7th 2019The FDA has approved the nanobody caplacizumab-yhdp in combination with plasma exchange and immunosuppression for the treatment of adult patients with acquired thrombotic thrombocytopenic purpura, making it the first FDA-approved therapy indicated for this patient population.