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.
Phase 1/2 Studies Set the Stage for Targeted Combos in B-Cell Lymphomas
April 27th 2021Although chemotherapy is not likely to lose its place in the frontline treatment of patients with B-cell lymphomas, encouraging data from early-phase studies evaluating the use of targeted agents in combination with and without chemotherapy are capturing the interest of investigators in the field.
EU Panel Recommends Adjuvant Osimertinib in Early-Stage EGFR+ NSCLC
April 26th 2021The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended osimertinib for the adjuvant treatment of adult patients with stage IB, II, or IIIA EGFR-mutated non–small cell lung cancer following complete tumor resection with curative intent.
Apalutamide Maintains OS Benefit in Castration-Sensitive Prostate Cancer
April 26th 2021Apalutamide plus androgen deprivation therapy maintained an overall survival advantage over placebo for a broad population of patients with metastatic castration-sensitive prostate cancer after nearly 4 years of median follow-up.
ODAC Hearings on 6 Immunotherapy Indications Set to Begin
April 26th 2021The FDA’s Oncologic Drugs Advisory Committee is poised to move forward this week with a public review of 6 indications for immune checkpoint inhibitors granted under the agency’s accelerated approval process that later failed to reach thresholds for statistical significance for key end points in confirmatory clinical trials.
Earlier Administration of Antiandrogens May Further Delay Disease Progression in Nonmetastatic CRPC
April 26th 2021Natasha Garg, DO, discusses the impact of antiandrogens in the treatment of patients with nonmetastatic CRPC, shared advice for choosing among the available options, and projected what the future paradigm might look like.
PD-1 Regimens Lead Charge Against Gastrointestinal Cancers
April 25th 2021With immunotherapy options expanding for patients with a range of gastrointestinal cancers to include combination strategies with chemotherapy, their use in the treatment course should come sooner rather than later for those with high PD-L1 expression.
FDA Approves Loncastuximab Tesirine for Relapsed/Refractory Large B-Cell Lymphoma
April 23rd 2021The FDA has granted an accelerated approval to loncastuximab tesirine (Zynlonta) for the treatment of adult patients with relapsed/refractory large B-cell lymphoma following 2 or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, DLBCL arising from low-grade lymphoma, and high-grade B-cell lymphoma.
EU Panel Recommends Nivolumab/Ipilimumab in Frontline Unresectable Malignant Pleural Mesothelioma
April 23rd 2021The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended the combination of nivolumab and ipilimumab as a frontline treatment for adult patients with unresectable malignant pleural mesothelioma.
Oral Azacitidine Recommended for EU Approval in AML
April 23rd 2021The European Medicines Agency’s Committee for Medicinal Products for Human Use has granted a positive opinion for the approval of oral azacitidine as a maintenance treatment for adult patients with acute myeloid leukemia who had a complete remission or CR with incomplete blood count recovery after induction therapy with or without consolidation treatment, and who are ineligible for or choose to not undergo hematopoietic stem cell transplant
Venetoclax-Based Regimens Get European Nod for Newly Diagnosed, Chemo-Ineligible AML
April 23rd 2021The European Medicines Agency Committee for Medicinal Products for Human Use has recommended to approve venetoclax for use in combination with hypomethylating agents for the treatment of adult patients with newly diagnosed acute myeloid leukemia who are ineligible for intensive chemotherapy.
Dostarlimab Approved in Europe for Advanced dMMR Endometrial Cancer
April 23rd 2021The European Commission has granted conditional marketing authorization to dostarlimab for the treatment of patients with microsatellite instability–high/mismatch repair deficient recurrent or advanced endometrial cancer who have progressed on or following prior therapy with a platinum-containing regimen.
FDA Approves VENTANA MMR RxDx as Companion Diagnostic for Dostarlimab in Endometrial Cancer
April 23rd 2021The FDA has approved the VENTANA MMR RxDx panel as a companion diagnostic assay to determine eligibility for dostarlimab-gxly as a treatment for patients with advanced or recurrent endometrial cancer whose tumors are mismatch repair deficient.
A Desire to Be a Healer Drives Breast Cancer Expert Forward
April 23rd 2021Sara A. Hurvitz, MD, can remember the exact moment she decided to become an oncologist. It was her first day at the University of Southern California School of Medicine, which she had entered in 1995 without a firm idea of what discipline she wanted to pursue.
Toripalimab/Chemo Combo Improves Survival in Frontline Esophageal Squamous Cell Carcinoma
April 22nd 2021The frontline combination of toripalimab and cisplatin/paclitaxel reached its prespecified primary end points of progression-free and overall survival in patients with advanced esophageal squamous cell carcinoma in the phase 3 JUPITER-06 trial.
FDA Approves Dostarlimab for Advanced dMMR Endometrial Cancer
April 22nd 2021The FDA has granted an accelerated approval to dostarlimab-gxly (Jemperli) for the treatment of patients with recurrent or advanced endometrial cancer that has progressed on or following prior treatment with a platinum-containing chemotherapy and whose cancers are mismatch repair deficient, as determined by an FDA-approved test.
Study Uses Precision Medicine to Speed Drug Testing for Pancreatic Cancer
April 22nd 2021Moores Cancer Center at UC San Diego Health is among the few clinical trial sites in the U.S. for the Pancreatic Cancer Action Network’s newly created Precision Promise, the first large-scale precision medicine trial designed to transform outcomes for patients with pancreatic cancer.