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.

Brentuximab Vedotin Plus AVD Gets Positive CHMP Opinion for CD30+ Stage III Hodgkin Lymphoma

September 18th 2023

The European Medicine Agency’s Committee for Medicinal Products for Human Use has recommended the approval of brentuximab vedotin in combination with doxorubicin, vinblastine, and dacarbazine in adult patients with previously untreated, CD30-positive, stage III Hodgkin lymphoma.

CHMP Recommends Against Renewal of Marketing Authorization for Belantamab Mafodotin in R/R Myeloma

September 18th 2023

The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended against renewal of the conditional marketing authorization for belantamab mafodotin-blmf for the treatment of patients with relapsed/refractory multiple myeloma who have received at least 4 prior treatments.

Trastuzumab Biosimilar Receives CHMP Recommendation for HER2+ Breast and Gastric Cancer

September 18th 2023

The European Medicines Agency’s Committee for Medicinal Products for Human Use has issued a positive opinion recommending marketing authorization of EirGenix’s biosimilar for trastuzumab for the treatment of patients with HER2-positive breast and metastatic gastric cancers.

Fox Chase Cancer Center Welcomes Dr. Sara Small

September 18th 2023

Fox Chase Cancer Center is pleased to announce the hiring of Sara Small, MD, PhD, as an assistant professor in the Department of Bone Marrow Transplant and Cellular Therapies.

IDEA Collaboration Affects Choice of Chemotherapy Regimen, Treatment Duration in Stage III Colon Cancer

September 18th 2023

Although findings from the International Duration Evaluation of Adjuvant Therapy collaboration in 2018 failed to demonstrate the noninferiority of 3 months of adjuvant chemotherapy vs 6 months for patients with stage III colon cancer, clinically relevant data in subgroup analyses have influenced practice prescribing patterns, according to a retrospective analysis.

Novel PROTAC May Usher in New Class of Drugs for ESR1+, ER+/HER2– Breast Cancer

September 18th 2023

The development of novel next-generation hormonal agents is poised to change the landscape for patients with estrogen receptor-positive, HER2-negative breast cancer, offering additional oral solutions to lessen the burden of the invasive delivery of the standard of care and provide agents that are active against acquired variants.

TKI Selection in CML Demands Nuanced Approaches

September 17th 2023

Choosing the most effective TKIs for individual patients with chronic myeloid leukemia requires decision making based on efficacy data, agent safety profiles, and patient characteristics, according to Michael Deininger, MD.

Cabozantinib Is Safe and Tolerable in Sorafenib-Intolerant HCC

September 16th 2023

The phase 2 ACTION trial, which evaluated the safety of second-line cabozantinib in patients with hepatocellular carcinoma who were intolerant to first-line sorafenib or who received agents other than sorafenib in the first line, did not meet its safety futility criteria, allowing the trial to continue.

CHMP Releases Positive Opinion for Quizartinib in Newly Diagnosed FLT3-ITD+ AML

September 15th 2023

The Committee for Medicinal Products for Human Use has recommended the approval of quizartinib in the European Union for use in combination with standard cytarabine and anthracycline induction and cytarabine consolidation chemotherapy, followed by maintenance quizartinib, for adult patients with newly diagnosed, FLT3-ITD–positive acute myeloid leukemia.

FDA Approves Momelotinib for Myelofibrosis With Anemia

September 15th 2023

The FDA has approved momelotinib (Ojjaara) for the treatment of adult patients with intermediate or high-risk myelofibrosis, including primary myelofibrosis or secondary myelofibrosis, and anemia.

Dana-Farber Cancer Institute and Beth Israel Deaconess Medical Center Forge New Collaboration to Advance Future of Adult Cancer Care; Announce Plans to Build Region’s Only Free-Standing Cancer Hospital

September 15th 2023

Dana-Farber Cancer Institute and Beth Israel Deaconess Medical Center announced plans for a comprehensive new collaboration designed to advance the future of cancer care and build the region’s only independent, free-standing inpatient hospital for adult cancer patients.

Trastuzumab Deruxtecan Receives CHMP Recommendation for Approval in HER2-Mutant NSCLC

September 15th 2023

The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended fam-trastuzumab deruxtecan-nxki for use as a single agent in adult patients with HER2-mutated, advanced non–small cell lung cancer who require systemic treatment after platinum-based chemotherapy with or without immunotherapy.

DNA/RNA Sequencing Aids Subsequent Treatment Selection in HCC/H-CCK Post Atezolizumab/Bevacizumab

September 15th 2023

Tissue- and blood-based molecular analysis could help match patients with advanced hepatocellular carcinoma or hepatocholangiocarcinoma following disease progression on frontline atezolizumab and bevacizumab to targeted therapy or another TKI based on identified genomic alterations.

Adjuvant Pembrolizumab Receives Positive CHMP Opinion for High-Risk NSCLC After Resection and Chemo

September 15th 2023

The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended the approval of pembrolizumab as adjuvant treatment for adult patients with non–small cell lung cancer who are at high risk of recurrence following complete resection and platinum-based chemotherapy.

FDA Extends Priority Review of BLA for Lifileucel in Advanced Melanoma

September 15th 2023

The FDA has extended the priority review period for the biologics license application seeking the approval of the tumor infiltrating lymphocyte therapy lifileucel for the treatment of patients with advanced melanoma who progressed on or after anti–PD-1/PD-L1 therapy and targeted therapy.

Continued Research Underscores the Need to Explore New Approaches Across the Breast Cancer Armamentarium

September 15th 2023

Stephanie L. Graff, MD, expands on treatment options available for patients with premenopausal breast cancer who are trying to conceive, highlighting the POSITIVE trial in women with endocrine-responsive breast cancer.

Use of IO-Based Therapy Associated With Real-World OS Benefit in HCC

September 15th 2023

The use of an immuno-oncology regimen as systemic therapy was found to be an independent prognostic factor and was associated with improved long-term survival for patients with hepatocellular carcinoma, regardless of IO’s sequencing in the first and later lines of treatment.

Extended Melphalan Flufenamide Indication Approaches EU Approval for R/R Multiple Myeloma

September 14th 2023

The European Medicines Agency’s Committee for Medicinal Products for Human Use has adopted a positive opinion regarding a Type II variation application to extend the therapeutic indication of melphalan flufenamide for use in adult patients with multiple myeloma who have received at least 2 prior lines of treatment and whose disease is refractory to lenalidomide and the last line of therapy.

Central Florida Cancer Care Center/Radiation Oncology Consultants Joins FCS

September 14th 2023

Florida Cancer Specialists & Research Institute, LLC is pleased to announce that Central Florida Cancer Care Center/Radiation Oncology Consultants, PA has joined the statewide practice.

FDA Approves New and Updated Indications for Temozolomide in Anaplastic Astrocytoma

September 14th 2023

The FDA has approved temozolomide (Temodar) for the adjuvant treatment of adult patients with newly diagnosed anaplastic astrocytoma. Under Project Renewal, the regulatory agency has also revised indications for the treatment of patients with refractory anaplastic astrocytoma.