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 Sacituzumab Govitecan Priority Review for Triple-Negative Breast Cancer
July 18th 2018The FDA has granted a priority review designation to a biologics license application for sacituzumab govitecan for the treatment of patients with metastatic triple-negative breast cancer following at least 2 prior therapies for metastatic disease.
FDA Expands Ribociclib Breast Cancer Approval Under New Pilot Programs
July 18th 2018The FDA has approved upfront ribociclib for use in combination with an aromatase inhibitor for the treatment of pre/perimenopausal or postmenopausal women with HR-positive/HER2-negative advanced or metastatic breast cancer. The agency also approved the CDK 4/6 inhibitor for use in combination with fulvestrant for the treatment of postmenopausal women with HR-positive/HER2-negative advanced or metastatic breast cancer, in the frontline setting or after disease progression on endocrine therapy.
CTC AR-V7 Assay Shows Promise as Treatment Guide in mCRPC
July 17th 2018An assay for nuclear-localized androgen receptor splice variant 7 protein in circulating tumor cells identified patients with metastatic castration-resistant prostate cancer who had better outcomes from treatment with taxanes, and those who did better with androgen receptor-signaling inhibitors.
Oncology Groups Respond to CMS' Proposals for Payment Cuts
July 14th 2018The Centers for Medicare & Medicaid Services has proposed a slate of changes that would reduce payment for some forms of patient evaluation and management and reduce the payment margin over wholesale acquisition cost for Medicare Part B drugs.
Expert Discusses Molecular Analysis and Treatment Options in Pediatric Ependymoma
July 12th 2018Santhosh A. Upadhyaya, MD, discusses how chemotherapy prior to radiation can improve cure rates, the importance of long-term follow-up in this patient population, and emerging research and treatment for pediatric ependymoma.
FDA Approval Sought for Frontline Venetoclax Combo in AML
July 12th 2018A supplemental New Drug Application has been submitted to the FDA for venetoclax (Venclexta) for use in combination with a hypomethylating agent or low-dose cytarabine for the first-line treatment of patients with acute myeloid leukemia.