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 Approves Rylaze for Acute Lymphoblastic Leukemia and Lymphoblastic Lymphoma
June 30th 2021The FDA has approved asparaginase erwinia chrysanthemi (recombinant)-rywn (Rylaze) as part of a chemotherapy regimen to treat pediatric and adult patients with acute lymphoblastic leukemia and lymphoblastic lymphoma who are allergic to the E. coli-derived asparaginase products.
CPX-351 Delivers Durable Improvement in OS in Older Patients With AML in Longer Follow-up
June 30th 2021The fixed combination of daunorubicin and cytarabine continued to demonstrate improved overall survival vs 7+3 chemotherapy in older patients with newly diagnosed high-risk or secondary acute myeloid leukemia.
Targeted Therapy Paradigm Grows in NSCLC, While Overcoming Resistance Represents Next Hurdle
June 29th 2021The field of targeted therapy for patients with non–small cell lung cancer has grown exponentially in recent years, with inhibitors for RET, MET exon 14 skipping, and KRAS G12C mutations transforming the paradigm.
Using NGS to Inform More Than Diagnosis in Myeloid Malignancies
June 29th 2021Next-generation sequencing plays a critical role in the diagnosis of patients with myeloid malignancies, but it also plays a necessary role in the identification of passenger mutations and subclonal events that go beyond founding drivers.
Nivolumab/Ipilimumab Approved in Europe for dMMR or MSI-H Metastatic Colorectal Cancer
June 29th 2021The European Commission has approved the combination of nivolumab plus ipilimumab for use in adult patients with mismatch repair deficient or microsatellite instability–high metastatic colorectal cancer following previous fluoropyrimidine-based combination chemotherapy.
Pembrolizumab/Chemo Approved in Europe for Select Esophageal Cancer or HER2– GEJ Adenocarcinoma
June 29th 2021The European Commission has approved pembrolizumab plus platinum- and fluoropyrimidine-based chemotherapy for the frontline treatment of patients with locally advanced unresectable or metastatic carcinoma of the esophagus or HER2-negative gastroesophageal junction adenocarcinoma whose tumors have PD-L1 expression.
Coleman Centers the Discussion on Practice-Affirming ASCO Trials in Gynecologic Oncology
June 29th 2021Practice-validating trials in cervical cancer, endometrial cancer, and ovarian cancer were the focus of the 2021 ASCO Annual Meeting in gynecologic oncology, each carrying relevant implications on extended therapy, surveillance, and biomarker testing.
Phase 1 CYNK-001 Trial Expands to Include Relapsed/Refractory AML Population
June 29th 2021A phase 1 study evaluating the off-the-shelf cell therapy CYNK-001 has expanded to include patients with relapsed/refractory acute myeloid leukemia after a case of conversion to minimal residual disease negativity at its highest dose level.
Balixafortide Plus Eribulin Fails to Improve ORR in Advanced HER2-Negative Breast Cancer
June 28th 2021The combination of balixafortide and eribulin did not significantly improve objective response rate over eribulin alone in the treatment of patients with HER2-negative, locally recurrent or metastatic breast cancer, missing the co-primary end point of the phase 3 FORTRESS study.
Galinpepimut-S Plus Nivolumab Shows Promising Preliminary Benefit in Mesothelioma
June 28th 2021The combination of the targeted cancer vaccine galinpepimut-S plus nivolumab resulted in a median overall survival of 35.4 weeks in patients with macroscopic deposits of malignant pleural mesothelioma who had received treatment for at least 1 month.
Second-Line Axi-Cel Significantly Improves EFS Over Standard of Care in Relapsed/Refractory LBCL
June 28th 2021Axicabtagene ciloleucel significantly improved event-free survival by 60% over chemotherapy plus stem cell transplant in the second-line treatment of patients with relapsed or refractory large B-cell lymphoma, meeting the primary end point of the phase 3 ZUMA-7 trial.
Frontline Cabozantinib Plus Atezolizumab Significantly Improves PFS in Advanced HCC
June 28th 2021The combination of cabozantinib and atezolizumab was found to significantly improve progression-free survival compared with sorafenib when used in the first-line treatment of patients with advanced hepatocellular carcinoma, meeting a primary end point of the phase 3 COSMIC-312 trial.
Lopes Shines a Light on the Explosion of Targeted Therapies in Lung Cancer Treatment Arsenal
June 26th 2021Gilberto Lopes, MD, discusses the latest developments made in the treatment of patients with non–small cell lung cancer whose tumors harbor genetic alterations and the clinical implications of recent regulatory approvals.