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.
EMA Accepts Marketing Application for Odronextamab in R/R DLBCL or Follicular Lymphoma
August 17th 2023The European Medicines Agency has accepted a marketing authorization application seeking the approval of odronextamab for the treatment of adult patients with relapsed/refractory follicular lymphoma or relapsed/refractory diffuse large B-cell lymphoma who have progressed after at least 2 prior systemic therapies.
On-Pathway Regimens Are Associated With Significant Cost Savings for Treatment of Solid Tumors
August 17th 2023Findings from a cross-institutional study suggest that on-pathway regimens led to significant cost savings for patients with cancer, despite the rate of hospitalizations and immune-related adverse events being similar between on-pathway and off-pathway regimens.
Randall Discusses the Importance of Identifying and Managing Chondroblastoma in Clinical Practice
August 16th 2023R. Lor Randall, MD, FACS, explains the difference between noncancerous chondroblastoma and other bone neoplasms, details the typical diagnosis and treatment of this rare condition, and emphasizes the importance of pediatric and medical oncologists being able to identify it in clinic.
Repotrectinib Sustains ORR, Safety in Locally Advanced or Metastatic ROS1+ NSCLC
August 16th 2023Treatment with repotrectinib continued to produce high and durable responses with a manageable safety profile in patients with ROS1-positive locally advanced or metastatic non–small cell lung cancer who were naïve to a TKI or previously treated with 1 TKI and no chemotherapy.
Tucatinib/Letrozole/Palbociclib Combination Demonstrates Meaningful Efficacy in HR+/HER2+ mBC
August 16th 2023Treatment with the all-oral triplet of tucatinib, letrozole, and palbociclib yielded clinically meaningful efficacy results and had an acceptable safety profile in patients with hormone receptor–positive, HER2-positive metastatic breast cancer.
Tucatinib Plus T-DM1 Improves PFS in Previously Treated HER2+ Metastatic Breast Cancer
August 16th 2023The combination of tucatinib and ado-trastuzumab emtansine elicited an improvement in progression-free survival compared with placebo plus T-DM1 in patients with HER2-positive metastatic breast cancer who received previous treatment with a taxane and trastuzumab in any setting.
Copper 64 PSMA I&T Meets Coprimary End Points of SOLAR Trial in Metastatic Prostate Cancer
August 15th 2023Use of Copper 64 PSMA I&T for PET/CT imaging met the threshold for significance regarding region-level correct localization rate and patient-level correct detection rate in patients with histologically confirmed metastatic prostate cancer, meeting the coprimary end points of the phase 2 SOLAR trial.
FDA Lifts Clinical Hold on BCMA-Directed Modified CAR T-Cell Therapy in Multiple Myeloma
August 15th 2023The FDA has lifted the partial clinical hold placed on the clinical program evaluating the investigational new drug, CART-ddBCMA, in the treatment of patients with relapsed/refractory multiple myeloma.
FDA Approves Companion Diagnostic for Niraparib Plus Abiraterone Acetate in BRCA+ mCRPC
August 14th 2023The FDA has approved FoundationOne CDx to be utilized as a companion diagnostic for the dual-action tablet of niraparib plus abiraterone acetate, which was approved for use in combination with prednisone in adult patients with deleterious or suspected deleterious BRCA-mutated metastatic castration-resistant prostate cancer.
Molecular Subtyping and Surgical Sequencing Broaden Immunotherapy Applications in RCC
August 14th 2023Tian Zhang, MD, discusses unanswered questions regarding molecular drivers of kidney cancer that the OPTIC RCC trial aims to answer, next steps with this research, and the potential benefits of receiving systemic therapy prior to undergoing cytoreductive nephrectomy for patients with metastatic renal cell carcinoma.
FDA Approves Elranatamab for Relapsed or Refractory Multiple Myeloma
August 14th 2023The FDA has granted accelerated approval to elranatamab-bcmm (Elrexfio) for the treatment of adult patients with relapsed or refractory multiple myeloma who have previously received at least 4 lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody.
BAT8006 Elicits Disease Control, Safety in Advanced Ovarian Cancer and Other Solid Tumors
August 14th 2023Treatment with the folate receptor–α antibody-drug conjugate BAT8006 led to responses with a manageable safety profile in patients with advanced solid tumors, including ovarian cancer, breast cancer, and cervical cancer.