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 Approval Sought for Daratumumab Plus Carfilzomib/Dexamethasone in Relapsed/Refractory Myeloma
February 11th 2020A supplemental Biologics License Application has been submitted to the FDA for daratumumab for use in combination with carfilzomib and dexamethasone for the treatment of patients with relapsed/refractory multiple myeloma.
FDA Grants Priority Review to Capmatinib in METex14+ NSCLC
February 11th 2020The FDA has granted a priority review designation to a new drug application for capmatinib for use as treatment for newly diagnosed and previously treated patients with locally advanced or metastatic MET exon14 skipping—mutated non–small cell lung cancer.
FDA Approves Pemetrexed Injection for Nonsquamous NSCLC and Malignant Pleural Mesothelioma
February 10th 2020The FDA has granted a final approval to pemetrexed for injection, an alternative to standard pemetrexed, for the treatment of patients with locally advanced or metastatic nonsquamous non–small cell lung cancer and for those with malignant pleural mesothelioma.
Dr. Singh on Dose Dense ACTHP in HER2+ Breast Cancer
February 7th 2020Jasmeet C. Singh, MD, discusses results from a retrospective analysis looking at the effectiveness of dose dense doxorubicin and cyclophosphamide followed by paclitaxel, trastuzumab, and pertuzumab in patients with HER2-positive breast cancer.
ACCC Quality Improvement Workshops Address the Need for Improved Chronic Lymphocytic Leukemia Care
February 5th 2020The Association of Community Cancer Centers is pleased to announce that its Multidisciplinary Chronic Lymphocytic Leukemia Care education project is conducting a series of quality improvement workshops to promote the optimal care and management of patients diagnosed with chronic lymphocytic leukemia.
ASCO Names Refinement of Surgical Treatment of Cancer as Advance of the Year
February 5th 2020Following significant progress made in the development of novel systemic therapies for patients with cancer, the role of surgery in oncology continues to evolve. To this end, ASCO has selected the refinement of surgical treatment of cancer as its Advance of the Year.
Rituximab Biosimilar Nears EU Approval for Oncologic and Other Indications
February 4th 2020The European Medicines Agency’s Committee for Medicinal Products for Human Use has adopted a positive opinion for a Marketing Authorization Application for the rituximab biosimilar PF-05280586 for the treatment of patients with non-Hodgkin lymphoma, chronic lymphocytic leukemia, rheumatoid arthritis, granulomatosis with polyangiitis and microscopic polyangiitis, and pemphigus vulgaris.