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.
Study Links Decline in PSA Screening to Increased Incidence of Advanced Prostate Cancer
May 25th 2020Decreases in local-stage and increases in distant- and regional-stage prostate cancer incidence may be the result of a recommendation by the US Preventive Services Task Force against PSA–based screenings.
NICE Recommends Atezolizumab Combo in Frontline TNBC
May 23rd 2020The UK's National Institute for Health and Care Excellence has recommended the combination of atezolizumab and nab-paclitaxel as a treatment for patients with unresectable, locally advanced, or metastatic triple-negative breast cancer whose tumors express PD-L1 at a level of 1% or more and have not had prior chemotherapy for metastatic disease.
Entinostat/Exemestane Combo Misses OS Endpoint in HR+ Breast Cancer
May 23rd 2020The combination of entinostat and exemestane did not show a statistically significant improvement in overall survival compared with exemestane alone in patients with advanced hormone receptor—positive, HER2-negative breast cancer who have progressed on a nonsteroidal aromatase inhibitor, missing the primary endpoint of the phase 3 E2112 trial.
Tisagenlecleucel Enhances Health-Related QoL in Relapsed/Refractory DLBCL
May 22nd 2020Tisagenlecleucel led to clinically meaningful and durable improvements in health-related quality of life in patients with relapsed/refractory diffuse large B-cell lymphoma who achieved a complete or partial response to the CD19-directed CAR T-cell therapy in the phase 2 JULIET trial.
Tafasitamab/Lenalidomide Combo Application Fast-Tracked in Europe
May 22nd 2020The European Medicines Agency has validated a Marketing Authorization for the combination of tafasitamab and lenalidomide, followed by single-agent lenalidomide, for the treatment of adult patients with relapsed/refractory diffuse large B-cell lymphoma, including DLBCL arising from low-grade lymphoma, who are ineligible for autologous stem cell transplant.
Despite Financial Incentives, Greater Understanding Is Needed to Back Biosimilar Use
May 22nd 2020Sandra Cuellar, PharmD, BCOP, discusses the benefits of using biosimilars in oncology, the approval process for these agents, and the reasons why biosimilars have been met with reluctance in the medical community.
Concurrent Cladribine/Rituximab Enhances MRD-Free Complete Responses in Hairy Cell Leukemia
May 22nd 2020Concurrent frontline therapy with cladribine and rituximab led to a significant improvement in minimal residual disease–free complete responses versus cladribine followed by delayed rituximab in patients with hairy cell leukemia.
FDA Approves Multiple Companion Diagnostics for Olaparib in HRR+ mCRPC
May 20th 2020The FDA has approved two companion diagnostics to identify patients with metastatic castration-resistant prostate cancer with homologous recombination repair mutations, making them eligible for treatment with olaparib.
FDA Approves Olaparib for HRR-Mutant mCRPC
May 20th 2020The FDA has approved olaparib for the treatment of adult patients with deleterious or suspected deleterious germline or somatic homologous recombination repair gene–mutated metastatic castration-resistant prostate cancer who have progressed following prior treatment with enzalutamide or abiraterone acetate.
Chaft Crafts Considerations for Restarting Immunotherapy in Lung Cancer
May 19th 2020Jamie E. Chaft, MD, provides insight into IRAEs and immunotherapy restart, considerations for immunotherapy in the pre- and post-operative period, outlines biomarker research in lung cancer, and projects her hopes for the future use of this approach in this space.
FDA Approves PD-L1 IHC 28-8 pharmDx as Companion Diagnostic for Nivolumab Plus Ipilimumab in NSCLC
May 18th 2020The FDA has approved PD-L1 IHC 28-8 pharmDx for use as a companion diagnostic to identify patients with metastatic non–small cell lung cancer with PD-L1 tumor expression ≥1%, making them eligible for frontline treatment with nivolumab plus ipilimumab.