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.
Trastuzumab Deruxtecan Improves Survival in Heavily Pretreated HER2+ Gastric/GEJ Cancer
January 28th 2020Trastuzumab deruxtecan (Enhertu) improved overall survival versus chemotherapy in patients with heavily pretreated unresectable or metastatic HER2-positive gastric or gastroesophageal junction cancer.
FDA Approval Sought for Frontline Atezolizumab Plus Bevacizumab in HCC
January 27th 2020A supplemental biologics license application has been submitted to the FDA for the combination of atezolizumab and bevacizumab for the treatment of patients with unresectable hepatocellular carcinoma who have not received prior systemic therapy.
Adjuvant Atezolizumab Misses DFS Endpoint in Muscle-Invasive Bladder Cancer
January 24th 2020Adjuvant treatment with atezolizumab did not significantly improve disease-free survival compared with observation in patients with muscle-invasive bladder cancer, missing the primary endpoint of the phase III IMvigor010 trial.
Adjuvant T-DM1 Approved in China for HER2+ Early Breast Cancer
January 24th 2020China’s State Administration of Drug Administration has approved ado-trastuzumab emtansine for the adjuvant treatment of patients with HER2-positive early breast cancer who have residual disease following a neoadjuvant trastuzumab-based regimen.
Frontline Daratumumab Regimen Approved in EU for Transplant-Eligible Myeloma
January 22nd 2020The European Commission has granted marketing authorization for daratumumab in combination with bortezomib, thalidomide, and dexamethasone for the treatment of patients with newly diagnosed multiple myeloma who are eligible for autologous stem cell transplant.
Polatuzumab Vedotin Approved in Europe for Relapsed/Refractory DLBCL
January 22nd 2020The European Commission has granted a conditional marketing authorization to polatuzumab vedotin in combination with bendamustine and rituximab for the treatment of adult patients with relapsed/refractory diffuse large B-cell lymphoma who are ineligible for hematopoietic stem cell transplant.
FDA Grants Priority Review to Belantamab Mafodotin for Relapsed/Refractory Myeloma
January 21st 2020The FDA has granted a priority review designation to a biologics license application for belantamab mafodotin as a treatment for patients with relapsed/refractory multiple myeloma who received prior therapy with an immunomodulatory drug, a proteasome inhibitor, and an anti-CD38 antibody.
Tislelizumab Frontline Combos Improve PFS in Squamous NSCLC
January 21st 2020The anti–PD-1 agent tislelizumab (BGB-A317) in combination with chemotherapy improved progression-free survival compared with chemotherapy alone as a first-line treatment for patients with advanced squamous non–small cell lung cancer.