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.
Retrospective Study Confirms Real-World Efficacy of Brexucabtagene Autoleucel in R/R B-ALL
June 2nd 2023Brexucabtagene autoleucel elicited high rates of complete remission with minimal residual disease negativity in real-world patients with relapsed or refractory B-cell acute lymphoblastic leukemia who received the CAR T-cell product as post-approval, standard-of-care treatment, according to data from a retrospective study.
Imetelstat Prolongs Transfusion Independence, Increases Hemoglobin in R/R MDS
June 2nd 2023Treatment with the first-in-class direct and competitive telomerase inhibitor imetelstat resulted in statistically significant and clinically meaningful efficacy in patients with heavily transfusion dependent, non-del(5q) lower-risk myelodysplastic syndrome that is relapsed or refractory to erythropoiesis stimulating agents, according to findings from the phase 3 IMerge trial.
Simple Hysterectomy Is Noninferior to Radical Hysterectomy in Low-risk, Early-stage Cervical Cancer
June 2nd 2023Simple hysterectomy was found to be noninferior to radical hysterectomy and pelvic node dissection in patients with low-risk, early-stage cervical cancer, according to results of the Canadian Cancer Trials Group CX.5/SHAPE trial.
EMA Committee Recommends Piflufolastat 18F PSMA PET Imaging Agent for Prostate Cancer
June 1st 2023The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended the approval of piflufolastat 18F, a prostate-specific membrane antigen–targeted positron emission tomography imaging agent, for use in prostate cancer detection.
HER3+ CTC Count May Affect Responses to Patritumab Deruxtecan in Pretreated Advanced Breast Cancer
June 1st 2023Higher baseline HER3-positive circulating tumor cell count at baseline and reduction following treatment initiation was associated with a higher likelihood of deriving an early response with patritumab deruxtecan in patients with hormone receptor–positive or HER2-low advanced breast cancer.
Olverembatinib Recommended for Breakthrough Therapy Designation in China for SDH-Deficient GIST
June 1st 2023The China National Medical Products Adminstration’s Center for Drug Evaluation has recommended that olverembatinib receive breakthrough therapy designation for the treatment of patients with gastrointestinal stromal tumor that is succinate dehydrogenase deficient.
Subcutaneous Pertuzumab/Trastuzumab Combo Continues to Prove Safe, Effective in HER2+ Breast Cancer
June 1st 2023Subcutaneous delivery of fixed-dose adjuvant pertuzumab plus trastuzumab proved to have favorable tolerability, with a safety profile consistent with that seen with intravenous delivery of the regimen in patients with HER2-positive breast cancer.
FDA Approves Olaparib/Abiraterone Combo for BRCA+ Metastatic Castration-Resistant Prostate Cancer
May 31st 2023The FDA has approved olaparib (Lynparza) plus abiraterone acetate (Zytiga) and prednisone or prednisolone for the treatment of patients with deleterious or suspected deleterious BRCA-mutated metastatic castration-resistant prostate cancer, as determined by an FDA-approved companion diagnostic test.
Panitumumab Plus Trifluridine-Tipiracil Improves Outcomes in RAS Wild-type mCRC
May 31st 2023The combination of panitumumab and standard-of-care trifluridine-tipiracil rechallenge delivered a progression-free survival benefit vs trifluridine-tipiracil alone in the third-line setting in patients with refractory RAS wild-type metastatic colorectal cancer, meeting the primary end point of the phase 2 VELO trial.
Atezolizumab Plus Trastuzumab/Vinorelbine Elicits Responses in HER2+ Advanced Breast Cancer
May 31st 2023Atezolizumab in combination with trastuzumab and vinorelbine generated responses and a tolerable safety profile in patients with HER2-positive, estrogen receptor–negative or ER-positive/PAM50 non-luminal advanced breast cancer, according to data from a prespecified interim analysis of the phase 2 ATREZZO trial.
Epcoritamab Approval Introduces Novel Later-line Treatment Option in R/R DLBCL
May 31st 2023Tycel Phillips, MD, discusses the significance of the FDA approval for epcoritamab in diffuse large B-cell lymphoma, key data from the EPCORE NHL-1 trial that support this approval, and how the approval of epcoritamab signals the expanding role of bispecific antibodies in this patient population.
Novel CDK9 Inhibitor Looks to Expand Options in MYC-Amplified Solid Tumors and Non-Hodgkin Lymphoma
May 31st 2023Investigators are aiming to add another agent to the treatment armamentarium for patients with relapsed or refractory solid tumors, as well as those with non-Hodgkin lymphoma, with the development of KB-0742, a CDK9 inhibitor.
PARP Inhibitors Represent Effective Upfront Ovarian Cancer Treatment Options
May 31st 2023Whitfield B. Growdon, MD, shares the potential implications of first-line PARP maintenance in newly diagnosed ovarian cancer, the importance of treating patients with effective therapies as early as possible, and where combination regimens could fit into the treatment paradigm going forward.
FDA Grants Priority Review to Lifileucel in Advanced Melanoma
May 30th 2023The FDA has granted priority review to the biologics license application for the tumor infiltrating lymphocyte therapy lifileucel for the treatment of patients with advanced melanoma who progressed on or after prior anti–PD-1/PD-L1 therapy and targeted therapy.
FDA Approves First Radiohybrid PSMA-targeted PET Imaging Agent for Prostate Cancer
May 30th 2023The FDA has approved flotufolastat F 18 injection (Posluma) for positron emission tomography of prostate-specific membrane antigen–positive lesions in men with prostate cancer with suspected metastasis who are eligible for initial definitive therapy or with suspected recurrence based on elevated serum prostate-specific antigen level.
Shifts In Ovarian Cancer Treatment Options Necessitate Continued Research
May 29th 2023Whitfield B. Growdon, MD, discusses the role PARP inhibitors have played in ovarian cancer since their introduction to the field, the updated clinical trial data that contributed to the indication withdrawals for these agents, and where future research in this area may be headed.