All Oncology News

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.

UK’s MHRA Extends Conditional Marketing Authorization for Trastuzumab Deruxtecan to Select HER2+ Metastatic Breast Cancer

August 18th 2022

The United Kingdom Medicines and Healthcare Products Regulatory Agency has extended the conditional marketing authorization of fam-trastuzumab deruxtecan-nxki for single-agent use in adult patients in Great Britain who have HER2-positive unresectable or metastatic breast cancer and have received 1 or more prior HER2-based regimens.

European Commission Approves Melphalan Flufenamide for Relapsed/Refractory Multiple Myeloma

August 18th 2022

The European Commission has approved melphalan flufenamide for use in combination with dexamethasone for the treatment of adult patients with multiple myeloma who have received at least 3 prior therapies.

Elotuzumab Plus Pomalidomide and Dexamethasone Displays Sustained OS Benefit in Relapsed/Refractory Multiple Myeloma

August 18th 2022

Elotuzumab plus pomalidomide and dexamethasone demonstrated a significant improvement in overall survival compared with pomalidomide and dexamethasone alone in patients with relapsed/refractory multiple myeloma who previously received treatment with lenalidomide and a proteasome inhibitor.

CCNE1 Amplifications Tied to Racial Disparities in Serous Endometrial Cancer Outcomes

August 18th 2022

Julian Schink, MD, discusses a study evaluating racial differences in the mutational landscape of serous endometrial cancer, underscores the need for appropriate genomic testing and treatment for Black women with the disease, and explains the importance of racial representation across clinical trials.

FDA Lifts Partial Clinical Hold on TakeAim Lymphoma Trial Evaluating Emavusertib in B-cell Malignancies

August 18th 2022

The FDA has lifted a partial clinical hold on the open-label, dose-escalating phase 1/2 TakeAim Lymphoma trial investigating the safety and efficacy of emavusertib in patients with relapsed or refractory B-cell malignancies.

Dana-Farber Brigham Cancer Center Opens New Facility in Foxborough

August 18th 2022

Dana-Farber Brigham Cancer Center opened a new facility in Foxborough, MA, which provides world-class cancer care to patients in southern Massachusetts and Rhode Island.

Tumor Agnostic Role of TMB Biomarker Faces Challenges

August 18th 2022

Although tumor mutational burden is established as a clinically informative feature of tumors, its optimal use in therapeutic decision-making faces many challenges, and we are only beginning to fully understand its strengths and limitations.

Lenalidomide Plus Rituximab Represents Acceptable Chemo-Free Alternative for Untreated Advanced Follicular Lymphoma

August 18th 2022

The combination of lenalidomide and rituximab demonstrated durable safety and efficacy that was comparable to that achieved with rituximab plus chemotherapy in previously untreated patients with follicular lymphoma, according to 6-year data from the phase 3 RELEVANCE trial.

Immunotherapy Combinations Launch Into Earlier Lines and Signal Success in Metastatic Solid Tumors

August 17th 2022

Successful, established immunotherapies that have been approved for use in the metastatic setting are rapidly moving forward into the adjuvant and neoadjuvant settings, and novel agents are emerging in later lines.

FDA Approves Beti-cel for β-thalassemia Requiring Transfusions

August 17th 2022

The FDA has approved betibeglogene autotemcel (Zynteglo) for the treatment of adult and pediatric patients with beta-thalassemia who require regular red blood cell transfusions.

Trastuzumab Deruxtecan Shakes Up Treatment Possibilities for HER2-Low Metastatic Breast Cancer

August 17th 2022

Katherine Tkaczuk, MD, discusses practice-changing data across breast cancer subtypes that were discussed at the 2022 ASCO Annual Meeting, including data from DESTINY-Breast04 and the phase 3 PALOMA-2 trial, plus the utilization of CDK4/6 inhibitors and PARP inhibitors for select patients with breast cancer.

Anbalcabtagene Autoleucel Shows Promise in Relapsed/Refractory LBCL

August 17th 2022

Won Seog Kim, MD, PhD, discusses the potential clinical role of Anbalcabtagene autoleucel in relapsed/refractory diffuse large B-cell lymphoma and the continued evolution of CAR T-cell therapy.

Unraveling of Genetic Mechanism Behind Tumor Formation May Improve Targeted Treatment for Cancer Patients

August 17th 2022

Avapritinib Meets Primary and Secondary End Points in PIONEER Trial in Non-Advanced Systemic Mastocytosis

August 17th 2022

Treatment with avapritinib led to clinically meaningful and statistically significant improvements in patient-reported symptoms and objective measures of mast cell burden in patients with non-advanced systemic mastocytosis.

FDA Accepts NDA for Momelotinib for Treatment of Myelofibrosis

August 17th 2022

The FDA has accepted a new drug application for momelotinib for the treatment of patients with myelofibrosis.

Long-term Data for CDK4/6 Inhibitors Solidify Role in Firstline HR+/HER2- Breast Cancer

August 17th 2022

CDK4/6 inhibitors have carved out a substantial role in the treatment of patients with hormone receptor–positive, HER2-negative breast cancer.

Maintenance Rituximab Prolongs Time to Next Treatment, OS in MCL

August 17th 2022

Maintenance rituximab following first-line bendamustine plus rituximab or a combination of rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone prolonged first-line treatment benefits and improved survival outcomes vs either induction regimen alone.

Liquid Biopsy Assay Expands Offerings to Include MRD, Disease Recurrence Detection in Early-Stage Breast and Lung Cancer

August 16th 2022

The Guardant Reveal assay has been expanded for the detection of minimal residual disease and disease recurrence in patients with early-stage breast cancer and lung cancer.

FDA Green Lights NGS-Based Companion Diagnostic for Trastuzumab Deruxtecan in HER2-Mutated NSCLC

August 16th 2022

The FDA has approved the Oncomine Dx Target Test as a companion diagnostic to identify patients with NSCLC harboring an activating HER2 mutation who may derive clinical benefit from treatment with fam-trastuzumab deruxtecan-nxki.

Ruxolitinib/Pomalidomide Combo Shows Feasibility in Myelofibrosis With Anemia

August 16th 2022

A combination regimen comprised of ruxolitinib and pomalidomide was found to be safe and feasible in a cohort of intermediate-2 and high-risk patients with primary or secondary myelofibrosis and anemia, according to data from the phase 1b/2 MPNSG-0212 trial.