All Oncology News

The European Medicines Agency has granted Priority Medicines designation to iopofosine I-131 for use in patients with Waldenström macroglobulinemia in patients who previously received at least 2 treatment regimens.

The FDA has granted fast track designation to KT-333 for the treatment of patients with relapsed/refractory cutaneous T-cell lymphoma and relapsed/refractory peripheral T-cell lymphoma.

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.

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.

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 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.

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.

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.

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.

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.

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.

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 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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

J. Randolph Hecht, MD, discusses the challenges researchers have faced in the development of cellular therapy for patients with solid tumors, and details how A2B530 could potentially overcome some of these obstacles.

The National Institute for Health and Care Excellence has published its Final Draft Guidance recommending the use of ruxolitinib as treatment for eligible patients in England and Wales with polycythemia vera that is resistant or intolerant to hydroxycarbamide/hydroxyurea.

The 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.

Brad 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.

Anna 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.

Yara 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.

The 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.

The integration of novel mRNA biomarkers into the ColoAlert® screening test resulted in high sensitivity and specificity for colorectal cancer.