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 Green Lights First Companion Diagnostic for Dostarlimab in dMMR Solid Tumors
August 18th 2021The FDA has approved the VENTANA MMR RxDx panel as the first companion diagnostic test to assist in identifying patients with solid tumors that are DNA mismatch repair deficient who may be eligible to receive the anti–PD-1 therapy dostarlimab-gxly, which was recently granted an accelerated approval by the agency.
Real-World Data Suggest Unmet Need for Effective Post-BTK Inhibitor Options in MCL
August 18th 2021For patients with mantle cell lymphoma who have progressed after treatment with a BTK inhibitor such as ibrutinib, there is an unmet need for the development of safe and effective targeted therapies to improve otherwise dismal outcomes.
FDA Grants Fast Track Designation to STRO-002 for Advanced Ovarian Cancer
August 18th 2021The FDA has granted a fast track designation to STRO-002 as a potential therapeutic option for patients with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer who have previously received 1 to 3 lines of systemic therapy.
FDA Approves Dostarlimab-gxly for dMMR Recurrent or Advanced Solid Tumors
August 17th 2021The FDA has granted an accelerated approval to dostarlimab-gxly for the treatment of adult patients with mismatch repair-deficient recurrent or advanced solid tumors, as determined by an FDA-approved test, who have progressed on or following previous treatment and who have no satisfactory alternative options.
Elranatamab May Represent Next Breakthrough in Relapsed/Refractory Myeloma
August 17th 2021Alexander M. Lesokhin, MD, discusses the promise of elranatamab in the treatment of patients with relapsed/refractory multiple myeloma, the objective of MagnetisMM-3, and other emerging approaches that are generating excitement in the paradigm.
EMA Validates Applications for Nivolumab/Ipilimumab, Nivolumab/Chemo in Frontline ESCC
August 17th 2021The European Medicines Agency has validated its Type II Variation Marketing Authorization Applications for nivolumab plus ipilimumab and nivolumab plus fluoropyrimidine- and platinum-containing chemotherapy as frontline options for adult patients with unresectable advanced, recurrent, or metastatic esophageal squamous cell carcinoma.
Average Cumulative Relative Adjuvant Chemo Dose Linked With Survival in CRC
August 17th 2021Average cumulative relative dose was found to be associated with survival over average relative dose intensity in patients with colorectal cancer, highlighting that obese patients receive lower cumulative doses of adjuvant chemotherapy and therefore may be attributed to their poorer survival outcomes.
Sintilimab/Chemo Improves OS in Frontline Advanced or Metastatic Gastric or GEJ Adenocarcinoma
August 16th 2021Sintilimab plus oxaliplatin/capecitabine significantly improved overall survival over chemotherapy alone when used as a first-line treatment in patients with unresectable, locally advanced, recurrent or metastatic gastric or gastroesophageal junction adenocarcinoma.
FDA Issues a Complete Response Letter for Vicineum for High-Risk, BCG-Unresponsive NMIBC
August 16th 2021The FDA has issued a complete response letter to Sesen Bio regarding its biologics license application for Vicineum for the treatment of patients with Bacillus Calmette-Guérin–unresponsive non–muscle invasive bladder cancer.
Tagawa Takes Stock of Future of Sacituzumab Govitecan in Urothelial Carcinoma
August 16th 2021Sacituzumab govitecan-hziy, a Trop-2directed antibody-drug conjugate with an SN-38 payload, has carved out a role in the treatment landscape for patients with locally advanced or metastatic urothelial cancer following accelerated approval by the FDA.
Misinformation on Cancer Prevention Stems from COVID-19 Communication Efforts
August 15th 2021One year ago, few objective observers would have suggested that the percentage of individuals who are currently fully vaccinated is less than 30%, despite the well-documented real-world success data for the vaccines in preventing serious illness, hospitalizations, and death from COVID-19 infection.
CAR T-Cell Therapy Use Requires Schooling of Adverse Event Recognition and Management
August 13th 2021Due to the potency of CAR T-cell therapies and the associated adverse events that can to arise in patients receiving this type of treatment, oncology nurses need to be educated on how to best identify and manage these AEs.
Non–CAR T-Based Strategies Shake Up the Management of Non-Hodgkin Lymphoma
August 13th 2021Stephen M. Ansell, MD, PhD, discusses recent progress made with non–CAR T-based approaches in the non-Hodgkin lymphoma treatment paradigm, opportunities for sequencing available options, and ongoing efforts that are picking up momentum.
FDA Approves Belzutifan for Cancers Linked With Von Hippel-Lindau Disease
August 13th 2021The FDA has approved belzutifan for the treatment of adult patients with von Hippel-Lindau disease who require therapy for associated renal cell carcinoma, central nervous system hemangioblastomas, or pancreatic neuroendocrine tumors that do not require immediate surgery.
Zandelisib Plus Rituximab Under Study in Indolent Non-Hodgkin Lymphoma
August 13th 2021Zandelisib plus rituximab is being evaluated as a potentially chemotherapy-free treatment strategy vs standard chemoimmunotherapy in patients with indolent non-Hodgkin lymphoma in first relapse in the ongoing, phase 3 COASTAL trial.