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 Selinexor in DLBCL
December 24th 2019An application has been submitted to the FDA for selinexor for the treatment of patients with relapsed/refractory diffuse large B-Cell lymphoma who have received at least 2 prior multiagent therapies and who are ineligible for stem cell transplantation, including CAR T-cell therapy.
Maintenance Rituximab After R-CHOP Shows Continued Benefit in Older Patients With MCL
December 23rd 2019Induction therapy with R-CHOP followed by maintenance rituximab continued to show improvements in survival and responses compared with R-CHOP and interferon-alpha maintenance in older patients with mantle cell lymphoma.
FDA Approval Sought for Tucatinib in HER2+ Breast Cancer
December 23rd 2019A new drug application has been submitted to the FDA for tucatinib for use in combination with trastuzumab and capecitabine for the treatment of patients with unresectable locally advanced or metastatic HER2-positive breast cancer.
FDA Approves Trastuzumab Deruxtecan for HER2+ Breast Cancer
December 21st 2019The FDA has granted an accelerated approval to fam-trastuzumab deruxtecan-nxki (Enhertu) for the treatment of adult patients with unresectable or metastatic HER2-positive breast cancer who have received ≥2 prior anti–HER2-based regimens in the metastatic setting.
Frontline Pembrolizumab Regimens Receive Japanese Approval in Head and Neck Cancer
December 20th 2019Japan's Pharmaceuticals and Medical Devices Agency has granted approval to frontline pembrolizumab as monotherapy and in combination with chemotherapy for the treatment of patients with recurrent or distant metastatic head and neck cancer.
Adjuvant T-DM1 Approved in Europe for HER2+ Early Breast Cancer
December 19th 2019The European Commission has approved ado-trastuzumab emtansine for the adjuvant treatment of adult patients with HER2-positive early breast cancer who have residual invasive disease (breast and/or lymph nodes) following neoadjuvant taxane-based chemotherapy and HER2-targeted therapy.
FDA Approval Sought for Tazemetostat in Follicular Lymphoma
December 19th 2019A new drug application has been submitted to the FDA for tazemetostat as a treatment for patients with relapsed/refractory follicular lymphoma, with or without EZH2 activating mutations, who have received ≥2 prior lines of systemic therapy.
FDA Approves Enfortumab Vedotin for Urothelial Cancer
December 19th 2019The FDA has approved enfortumab vedotin-ejfv for the treatment of adult patients with locally advanced or metastatic urothelial cancer who have received prior treatment with a PD-1/PD-L1 inhibitor and platinum-containing chemotherapy.
FDA Approval Sought for Liso-Cel in Large B-Cell Lymphoma
December 19th 2019Bristol-Myers Squibb has submitted a biologics license application to the FDA seeking approval of the anti-CD19 CAR T-cell therapy lisocabtagene maraleucel for the treatment of adult patients with relapsed/refractory large B-cell lymphoma after at least 2 prior therapies.
FDA Grants Priority Review to Encorafenib/Cetuximab Combo for BRAF+ mCRC
December 19th 2019The FDA has granted a priority review designation to a supplemental new drug application for the combination of encorafenib and cetuximab as a treatment for patients with advanced BRAF V600E­–mutant metastatic colorectal cancer following up to 2 prior lines of therapy.