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.
Lutetium Lu 177 Vipivotide Tetraxetan Provides HRQOL Benefit, Reduces Skeletal Events in mCRPC
July 9th 2023The addition of lutetium Lu 177 vipivotide tetraxetan to standard-of-care treatment delayed time to worsening of health-related quality of life and skeletal events compared with standard of care alone for patients with metastatic castration-resistant prostate cancer.
CDK4/6 Inhibitor Selection and Sequencing Continue to Evolve in HR+ Breast Cancer
July 8th 2023Sarah Sammons, MD, discusses the evolving role of CDK4/6 inhibitors in hormone receptor–positive breast cancer, the future of antibody-drug conjugates in triple-negative breast cancer, and the importance of educating patients about their available treatment options so they can share in the decision-making process.
Equecabtagene Autoleucel Approved in China for Relapsed/Refractory Multiple Myeloma
July 7th 2023China’s National Medical Products Administration has approved the new drug application for equecabtagene autoleucel for the treatment of adult patients with relapsed or refractory multiple myeloma who previously received 3 or more lines of therapy, including a proteasome inhibitor and an immunomodulatory drug.
Long-Term OS Data Confirm Pembrolizumab/Lenvatinib as a Primary Frontline Option in Advanced RCC
July 7th 2023Thomas Hutson, DO, PharmD, expands on previously reported findings from the CLEAR study, details updated data from the final OS analysis, and emphasizes how these results support the use of this regimen as a mainstay treatment option in the frontline setting for patients with advanced RCC.
Fixed-Duration CAPTIVATE Regimen Is Effective in CLL Regardless of High-Risk Genomic Features
July 7th 2023Treatment with fixed-duration ibrutinib plus venetoclax for patients with chronic lymphocytic leukemia in the first-line setting elicited durable responses and sustained progression-free survival outcomes regardless of high-risk genomic features.
BLU-945 Plus Osimertinib Has Favorable Tolerability, Warrants Further Development in EGFR+ NSCLC
July 7th 2023BLU-945 alone or in combination with osimertinib demonstrated early signals of clinical activity and was well tolerated in heavily pretreated patients with EGFR-mutant non–small cell lung cancer.
Zenocutuzumab Wins FDA Breakthrough Therapy Designation for Advanced NRG1+ NSCLC
July 7th 2023The FDA has granted breakthrough therapy designation to zenocutuzumab for use as a potential therapeutic option in patients with advanced unresectable or metastatic, NRG1 fusion–positive non–small cell lung cancer following progression with prior systemic therapy.
FDA Lifts Partial Clinical Hold on TakeAim Leukemia Trial of Emavusertib in AML/MDS
July 6th 2023The FDA has lifted a partial clinical hold on the phase 1/2 TakeAim Leukemia trial evaluating emavusertib monotherapy and in combination with azacitidine and venetoclax in patients with relapsed/refractory acute myeloid leukemia or high-risk myelodysplastic syndrome.
Glofitamab Monotherapy Produces Sustained Responses in Richter Syndrome
July 6th 2023Administration of glofitamab after pretreatment with obinutuzumab provided encouraging antitumor activity with high and durable complete response rates and a manageable safety profile in heavily pretreated patients with Richter syndrome.
FDA Grants Priority Review to Zolbetuximab for CLDN18.2+ Advanced Gastric/GEJ Adenocarcinoma
July 6th 2023The FDA has granted a priority review to the biologics license application seeking the approval of zolbetuximab for the first-line treatment of patients with unresectable, locally advanced or metastatic, HER2-negative, gastric or gastroesophageal junction adenocarcinoma whose tumors are Claudin18.2 positive.
Addressing Health in Areas Characterized by Persistent Poverty
July 6th 2023The Center for Health Outcomes and Population Equity at Huntsman Cancer Institute and the University of Utah, in partnership with the Montana State University Center for American Indian and Rural Health Equity, received a grant for Cancer Control in Persistent Poverty Areas from the National Cancer Institute.
Earlier Use of Ide-Cel May Increase Benefit for Patients With High-Risk R/R Myeloma
July 6th 2023Krina K. Patel, MD, MSc, expands on the importance of evaluating outcomes for treatment with ide-cel in patients with relapsed/refractory multiple myeloma with different high-risk characteristics and key findings from the high-risk subgroup analysis of the KarMMa-3 trial.
Botensilimab Plus Balstilimab Provides OS Benefit in Heavily Pretreated MSS mCRC
July 5th 2023The combination of botensilimab and balstilimab elicited durable responses and provided overall survival benefits in patients with microsatellite stable metastatic colorectal cancer that is resistant to chemotherapy and/or immunotherapy.
TAS-102/Bevacizumab Prolongs OS, PFS in Patients With mCRC and Maintained ECOG PS of 0 or 1
July 5th 2023Julien Taieb, MD, discusses the importance of combining fluoropyrimidines with bevacizumab, key findings from the SUNLIGHT trial and the post-hoc analysis, and how these results may shake up the colorectal cancer treatment paradigm.
FDA Approves Ready-to-Dilute Cyclophosphamide Injection for Various Cancers
July 5th 2023The FDA has approved a new drug application for 200-mg/mL vials of cyclophosphamide injection for use in combination therapy in the treatment of patients with various types of cancers, including malignant lymphoma, multiple myeloma, and various types of leukemia.
Datopotamab Deruxtecan Significantly Improves PFS in Advanced NSCLC
July 5th 2023Datopotamab deruxtecan provided a statistically significant improvement in progression-free survival compared with standard-of-care docetaxel in patients with locally advanced or metastatic non–small cell lung cancer who received at least 1 prior line of therapy.
Disitamab Vedotin Plus Toripalimab Elicits Responses, Safety in Metastatic Urothelial Carcinoma
July 4th 2023The combination of disitamab vedotin with toripalimab generated responses and displayed a manageable safety profile in patients with locally advanced or metastatic urothelial carcinoma, irrespective of HER2 expression.