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.
Luspatercept Data Published in NEJM Highlight Benefit for Beta Thalassemia-Associated Anemia
March 28th 2020Results from the pivotal phase III BELIEVE trial, which supported the FDA approval of luspatercept-aamt for the treatment of anemia in adult patients with beta thalassemia who require regular red blood cell transfusions, have been published in the New England Journal of Medicine.
Cancer Experts Come Together in the Fight Against Coronavirus
March 27th 2020As the number of confirmed cases of COVID-19 continues to grow, oncologists from all over the world are working together to stay informed on the latest developments, participate in pivotal research efforts, develop potentially life-saving medications, and share personal experiences faced in practice to ultimately improve patient care.
Avapritinib Approval Sought in Taiwan for PDGFRA Exon 18+ GIST
March 27th 2020A new drug application has been submitted to the Taiwan Food and Drug Administration for avapritinib for the treatment of adult patients with unresectable or metastatic gastrointestinal stromal tumor harboring PDGFRA exon 18 mutations, including PDGFRA D842V mutations, according to CStone Pharmaceuticals, a partner of Blueprint Medicines.
Isatuximab Nears European Approval for Relapsed/Refractory Myeloma
March 27th 2020The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended isatuximab in combination with pomalidomide and dexamethasone for the treatment of adult patients with relapsed/refractory multiple myeloma who have received ≥2 prior therapies.
Rini Shares Challenges in Keeping Up With COVID-19 in Oncology
March 27th 2020Brian I. Rini, MD, highlights the Uromigos podcast efforts to educate other oncologists on how COVID-19 will shift their practice, as well as adapting to changing procedures in clinic to continue delivering optimal care for patients with cancer during the pandemic.
VB-111 Hits Milestone in Phase III Platinum-Resistant Ovarian Cancer Trial
March 27th 2020An independent panel determined that the investigational agent VB-111 met the interim prespecified efficacy criterion in the phase III OVAL study in patients with platinum-resistant ovarian cancer, and that the trial should continue without modification.
Long-Term Follow-Up Validates Noninferiority Between Radiation Regimens in Prostate Cancer
March 25th 2020Moderate hypofractionated intensity-modulated radiation therapy did not show biochemical and/or clinical disease failure rate superiority compared with conventionally fractioned IMRT for men with intermediate- and high-risk prostate adenocarcinoma.
FDA Grants IPI-549 Fast Track Designation in Urothelial Carcinoma
March 25th 2020The FDA has granted a Fast Track Designation to IPI-549 for use in combination with nivolumab for the treatment of patients with advanced urothelial cancer, according to Infinity Pharmaceuticals, Inc., the manufacturer of the PI3K-gamma inhibitor.