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 Approves Olaparib for Frontline Maintenance in Ovarian Cancer
December 20th 2018The FDA has approved olaparib as a maintenance treatment for patients with deleterious or suspected deleterious germline or somatic BRCA-mutated advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in complete or partial response to frontline platinum-based chemotherapy.
Cemiplimab Combo Falls Short Versus Anti–PD-1 Monotherapy in HNSCC
December 19th 2018The PD-1 inhibitor cemiplimab in combination with radiotherapy, cyclophosphamide, and GM-CSF did not demonstrate efficacy superior to other PD-1 inhibitor monotherapies in patients with recurrent or metastatic head and neck squamous cell carcinoma.
Biosimilar Filgrastim Would Lower Medicare Out-of-Pocket Expenses
December 19th 2018Out-of-pocket expenditures are substantially less among Medicare beneficiaries with breast cancer undergoing chemotherapy who receive prophylaxis for febrile neutropenia with a filgrastim biosimilar as opposed to the reference product.
Neratinib Improves PFS in HER2+ Metastatic Breast Cancer
December 19th 2018Neratinib led to a statistically significant improvement in centrally confirmed progression-free survival compared with lapatinib and capecitabine in patients with HER2-positive metastatic breast cancer who have failed 2 or more prior lines of HER2-directed therapy.
Cemiplimab Antitumor Activity in CSCC Sustained With Longer Follow-up
December 17th 2018The monoclonal anti-PD-1 antibody cemiplimab continued to demonstrate considerable antitumor activity and durable responses in patients with unresectable locally advanced or metastatic cutaneous squamous cell carcinoma.
EU Panel Backs Dasatinib for Pediatric Ph+ ALL
December 17th 2018The European Medicines Agency's Committee for Medicinal Products for Human Use has granted a positive opinion to dasatinib in combination with chemotherapy for the treatment of pediatric patients with newly diagnosed Philadelphia chromosome-positive acute lymphoblastic leukemia.
EU Panel Backs Brentuximab Vedotin for Frontline CD30+ Hodgkin Lymphoma
December 15th 2018The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended approval of brentuximab vedotin for use in combination with chemotherapy as a frontline treatment for adult patients with CD30+ stage IV Hodgkin lymphoma.
Trastuzumab Biosimilar CT-P6 Shows Comparable Efficacy at 2-Year Follow-up
December 14th 2018CT-P6, a proposed biosimilar to trastuzumab, exhibited long-term disease-free survival and overall survival similar to the reference product in the treatment of patients with HER2-positive early breast cancer.