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.
Brentuximab Vedotin Demonstrates Durable Long-Term PFS Benefit in Hodgkin Lymphoma
December 18th 2019The addition of brentuximab vedotin to standard 3-drug chemotherapy for patients with newly diagnosed, advanced-stage classical Hodgkin lymphoma continued to outperform a 4-drug chemotherapy standard.
FDA Grants Tucatinib Breakthrough Designation for HER2+ Breast Cancer
December 18th 2019The FDA has granted tucatinib a breakthrough therapy designation for use in combination with trastuzumab and capecitabine for the treatment of patients with unresectable locally advanced or metastatic HER2-positive breast cancer, including patients with brain metastases, who had prior trastuzumab, pertuzumab, and ado-trastuzumab emtansine.
FDA Panel Supports Pembrolizumab for High-Risk NMIBC
December 18th 2019The FDA’s Oncologic Drugs Advisory Committee voted in support of approving pembrolizumab for the treatment of patients with Bacillus Calmette-Guerin–unresponsive, high-risk, non-muscle invasive bladder cancer with carcinoma in-situ with or without papillary tumors who are ineligible for or chose to not undergo cystectomy.
FDA Approval Sought for Belantamab Mafodotin in Relapsed/Refractory Myeloma
December 17th 2019A biologics license application has been filed with the FDA for belantamab mafodotin for the treatment of patients with relapsed or refractory multiple myeloma whose prior therapy included an immunomodulatory drug, a proteasome inhibitor, and an anti-CD38 antibody.
FDA Panel Backs Maintenance Olaparib for Metastatic Pancreatic Cancer
December 17th 2019The FDA’s Oncologic Drugs Advisory Committee voted 7 to 5 in favor of olaparib tablets for an indication as a maintenance treatment of adult patients with deleterious or suspected deleterious BRCA-mutant metastatic pancreatic adenocarcinoma whose disease has not progressed on frontline platinum-based chemotherapy.
FDA Approval Sought for Ripretinib for Advanced GIST
December 16th 2019A new drug application has been submitted to the FDA for ripretinib for use as a treatment for patients with advanced gastrointestinal stromal tumors who have previously received treatment with imatinib, sunitinib, and regorafenib.
Published Entrectinib Data Demonstrate Encouraging Responses in ROS1+ NSCLC
December 16th 2019Treatment with entrectinib led to an overall response rate of 77% and a median duration of response of 24.6 months in patients with ROS1 fusion–positive non–small cell lung cancer, according to updated findings of a pooled analysis published in Lancet Oncology.
Idecabtagene Vicleucel Meets ORR Endpoint in Relapsed/Refractory Multiple Myeloma
December 7th 2019Treatment with the BCMA-targeted CAR T-cell therapy idecabtagene vicleucel was associated with a 73.4% overall response rate in patients with relapsed/refractory multiple myeloma, meeting the primary endpoint of the pivotal phase II KarMMA trial.
Nadofaragene Firadenovec Meets Complete Response Endpoint in High-Grade NMIBC
December 7th 2019The investigational gene therapy nadofaragene firadenovec demonstrated a 3-month complete response rate of 53% in patients with high-grade, Bacillus Calmette-Guérin–unresponsive, non-muscle invasive bladder cancer with carcinoma in-situ with or without concomitant high-grade Ta or T1 papillary disease, meeting the primary endpoint of a phase III trial.