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 2023The 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 2023The 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 2023The 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.
Novel PROTAC May Usher in New Class of Drugs for ESR1+, ER+/HER2– Breast Cancer
September 18th 2023The 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.
Cabozantinib Is Safe and Tolerable in Sorafenib-Intolerant HCC
September 16th 2023The 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 2023The 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.
Trastuzumab Deruxtecan Receives CHMP Recommendation for Approval in HER2-Mutant NSCLC
September 15th 2023The 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 2023Tissue- 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 2023The 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 2023The 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.
Use of IO-Based Therapy Associated With Real-World OS Benefit in HCC
September 15th 2023The 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 2023The 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.
FDA Approves New and Updated Indications for Temozolomide in Anaplastic Astrocytoma
September 14th 2023The 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.
Golidocitinib NDA Under NMPA Review for Relapsed/Refractory PTCL
September 14th 2023The Center for Drug Evaluation of China’s National Medical Products Administration has accepted the new drug application seeking the approval of golidocitinib for the treatment of patients with relapsed/refractory peripheral T-cell lymphoma.
Ongoing Trials Could Shift BTK Inhibitors to Earlier Settings in MCL
September 14th 2023Brad S. Kahl, MD, discusses the evolving role of BTK inhibitors in the treatment of patients with mantle cell lymphoma, expands on key ongoing trials investigating these agents in earlier settings and in different combinations, and expands on what the addition of pirtobrutinib to the treatment arsenal has meant for this population.
Subcutaneous Amivantamab Is Associated With Increased Tolerability in Solid Tumors
September 14th 2023Anna Minchom, MB BCh, MRCP, MD, discusses the need to develop an amivantamab administration method that decreases the likelihood of infusion-related reactions in patients with solid tumors, revealed the RP2D of subcutaneous amivantamab that was determined in the PALOMA trial, and emphasized potential future directions with this agent.
Novel Treatment Regimens Populate the HR+/HER2– and HER2+ Breast Cancer Armamentariums
September 14th 2023Yara Abdou, MD, discusses key updates in breast cancer research, including paradigm shifts on the horizon for trastuzumab deruxtecan, key data regarding capivasertib in the hormone receptor–positive, HER2-negative setting, and the importance of weighing the efficacy benefits of these agents with the risks for serious associated toxicities.
FDA Grants Fast Track Status to Tulmimetostat for Endometrial Cancer
September 13th 2023The FDA has granted fast track designation to tulmimetostat for use as a potential therapeutic option in patients with advanced, recurrent, or metastatic endometrial cancer harboring ARID1A mutations and whose disease had progressed on at least 1 prior line of therapy.