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.
FDA Grants Fast Track Designation to IDE161 for Select Pretreated BRCA1/2-Mutated HR+ Breast Cancer
September 27th 2023The FDA has granted fast track designation to IDE161 for use in adult patients with advanced or metastatic hormone receptor–positive, HER2-negative breast cancer harboring BRCA1/2 mutations who have progressed after at least 1 hormonal therapy, a CDK4/6 inhibitor, and a PARP inhibitor.
Gilead Discontinues Phase 3 ENHANCE-2 Trial of Magrolimab Plus Azacitidine in TP53-Mutant AML
September 27th 2023The phase 3 ENHANCE-2 trial examining the frontline combination of magrolimab and azacitidine vs physician’s choice of venetoclax with azacitidine or intensive chemotherapy in patients with acute myeloid leukemia and TP53 mutations has been discontinued, according to an announcement from Gilead Sciences.
Phase 1 Trial Seeks to Determine the Role for Upfront Uproleselan in AML
September 27th 2023Naval G. Daver, MD, discusses the rationale for investigating uproleselan combinations in patients with acute myeloid leukemia, the current role of quizartinib in patients with FLT3-ITD–mutated disease, and potential future directions with both these agents in the AML field.
Research Demonstrates the Importance of Effective Frontline Regimens for High-Risk Multiple Myeloma
September 27th 2023Saad Z. Usmani, MD, MBA, FACP, discusses key points from his presentation at the 2023 SOHO Annual Meeting on frontline treatment of patients with high-risk myeloma, including the characteristics of patients with disease at high risk of recurrence, current treatment approaches, and ongoing research aiming to address unmet needs for this subset of patients.
Isa-KRd Elicits MRD-Negative Remissions in Newly Diagnosed, High-Risk Myeloma
September 27th 2023Treatment with the combination of isatuximab, carfilzomib, lenalidomide, and dexamethasone generated high rates of minimal residual disease negativity in patients with newly diagnosed, high-risk multiple myeloma, irrespective of transplant status.
Novel Sequencing Strategies May Expand Localized and Metastatic Breast Cancer Treatment Landscapes
September 27th 2023Jairam Krishnamurthy, MD, FACP, highlights the benefits of neoadjuvant therapy in early-stage HER2-positive breast cancer, treatment considerations for patients with HER2-negative disease who have progressed on an initial CDK4/6 inhibitor, and ongoing research that may address unmet needs in the field.
FDA Approves Bosutinib for Pediatric Ph+ CP-CML
September 27th 2023The FDA has approved bosutinib (Bosulif) for the treatment of pediatric patients 1 year of age and older with Philadelphia chromosome–positive, chronic-phase chronic myelogenous leukemia that is newly diagnosed or resistant or intolerant to prior therapy.
KIT Inhibitors Lead to Shift in Treatment of Systemic Mastocytosis
September 26th 2023The hematologic neoplasm systemic mastocytosis is marked by the clonal proliferation of mast cells in the skin, bone marrow, gastrointestinal tract, spleen, and/or liver, caused by an activating KIT mutation in the KIT gene.
Deeper Understanding of immune System Could Advance Treatment Options in Lymphoma
September 26th 2023Stephen M. Ansell, MD, PhD, discusses the successes and challenges of utilizing immune therapy across the landscape of hematologic malignancies, the importance of increasing the understanding of how the immune system functions in patients with lymphoma, and ongoing research of immune therapy for this patient population.
FDA Grants Fast Track Designation to IDE161 for BRCA+, Platinum-Resistant Advanced Ovarian Cancer
September 26th 2023The FDA has granted fast track designation to IDE161 for the treatment of adult patients with advanced or metastatic ovarian cancer harboring germline or somatic BRCA1/2 mutations who are platinum resistant and have received prior treatment with antiangiogenic and PARP inhibitor therapies.
Multidisciplinary Approaches Shape Treatment Pathways in EGFR-Mutated NSCLC
September 26th 2023Emerging data in the neoadjuvant setting and the expansion of testing in standard practice have presented questions surrounding screening for and developing strategies from variant information in EGFR-mutated resectable non–small cell lung cancer.
FDA Issues CRL to BLA for On-Body Injector Presentation of Pegfilgrastim-cbqv
September 25th 2023The FDA has issued a complete response letter to the biologics license application seeking the approval of the on-body injector presentation of pegfilgrastim-cbqv, which is a biosimilar of pegfilgrastim.
Luspatercept Broadens Lower-Risk MDS Treatment Landscape
September 25th 2023Guillermo Garcia-Manero, M, discusses key efficacy and safety findings from the COMMANDS trial; the significance of the FDA approval of luspatercept in patients with lower-risk MDS; and considerations for bringing this agent into clinical practice.
Novel Combinations Seek to Build Off Lenalidomide/Rituximab Backbone in Indolent Lymphoma
September 25th 2023Paolo Strati, MD, discusses novel combinations for the treatment of indolent B-cell lymphoma, emphasizes the primary goal of improving the efficacy of immunotherapy and providing patients with chemotherapy-free treatment options, and highlights ongoing trials are investigating various approaches to enhance the activity of lenalidomide/rituximab
Smoldering Multiple Myeloma Management Hinges on the Debate Between Treatment and Observation
September 25th 2023The smoldering multiple myeloma treatment paradigm harbors fractures in the consensus regarding the optimal management of this disease, with some experts favoring a watch-and-wait approach and others advocating for early treatment.
Deep Learning Reveals Valuable Clues About Kidney Cancer in Pathology Slides
September 25th 2023A team of Dana-Farber researchers has identified a potential new way to assess clinically valuable features of clear cell renal cell carcinoma, a form of kidney cancer, using image processing with deep learning.
Physicians Must Become Advocates to Play a Role in Community Oncology’s Future
September 25th 2023Although some community oncologists may think they can do little to abate the reimbursement reform forces that are affecting their practices, there are actions they can, and should, take to influence the success of their value-based care journey that may not be part of the fundamentals of their current practice.
Zotatifin Triplet May Improve Outcomes Post–CDK4/6 Inhibition in ER+ Breast Cancer
September 24th 2023Ezra Rosen, MD, PhD, highlights the early-phase investigation of zotatifin in estrogen receptor-positive metastatic breast cancer, explains the agent’s unique mechanism of action as well as its efficacy and safety in a heavily pretreated population, and underscores the need for improved sequencing of the myriad of treatment options in the post–CDK4/6 inhibitor space.
European Commission Approves Enrylaze for ALL and Lymphoblastic Lymphoma
September 22nd 2023The European Commission has granted marketing authorization for Enrylaze for use as a component of a multi-agent chemotherapeutic regimen for the treatment of patients with acute lymphoblastic leukemia and lymphoblastic lymphoma in adult and pediatric patients 1 month and older who developed hypersensitivity or silent inactivation to E. coli–derived asparaginase.
Pembrolizumab/Lenvatinib Regimens Miss Survival End Points in Metastatic NSCLC
September 22nd 2023The first-line combination of pembrolizumab, lenvatinib, pemetrexed, and platinum-containing chemotherapy did not meet the dual primary end points of overall survival and progression-free survival compared with pembrolizumab plus pemetrexed and platinum-containing chemotherapy in patients with metastatic, nonsquamous non–small cell lung cancer in whom EGFR-, ALK- or ROS1-directed therapies were not indicated.