The OncFive: Top Oncology Articles for the Week of 10/19

Welcome to OncLive®’s OncFive!

Every week, we bring you a quick roundup of the 5 top stories from the world of oncology—ranging from pivotal regulatory decisions to key pipeline updates to expert insights on breakthroughs that are moving the needle in cancer care. This resource is designed to keep you informed on the latest updates in the space, in just a matter of minutes.

Here’s what you may have missed this week:

FDA Approves Belantamab Mafodotin Plus Bortezomib and Dexamethasone for R/R Multiple Myeloma

The FDA approved belantamab mafodotin-blmf (Blenrep) in combination with bortezomib (Velcade) and dexamethasone (BVd) for the treatment of adult patients with relapsed or refractory multiple myeloma after at least 2 previous lines of therapy, including a proteasome inhibitor and an immunomodulatory drug. The decision was supported by findings from the phase 3 DREAMM-7 trial (NCT04246047), where BVd (n = 108) significantly improved overall survival (OS; HR, 0.49) and progression-free survival (HR, 0.31) compared with daratumumab (Darzalex) plus bortezomib and dexamethasone (DVd; n = 109). Safety data were consistent with what has previously been reported with the individual agents, although BVd was linked with notable ocular adverse effects. The FDA’s Oncologic Drugs Advisory Committee previously voted 5 to 3 against the regimen due to safety concerns, including ocular toxicity and serious adverse effects (AEs). Belantamab mafodotin is the first community-accessible BCMA-targeted therapy approved in this setting, expanding options for patients with relapsed or refractory disease.

FDA Approves Revumenib for Relapsed/Refractory NPM1-Mutant Acute Myeloid Leukemia

The FDA also cleared revumenib (Revuforj) for adults and children at least 1 year old with relapsed or refractory acute myeloid leukemia (AML) harboring a susceptible NPM1 mutation, who lack satisfactory alternative options. The decision is based on data from the phase 1/2 AUGMENT-101 trial (NCT04065399), where revumenib (n = 65) achieved a complete response (CR)/CR with partial hematological recovery (CRh) rate of 23.1% with a median duration of 4.5 months in this population. Responses occurred quickly, with a median time to CR/CRh of 2.8 months. Moreover, 17% of patients who were transfusion dependent at baseline (n = 46) achieved transfusion independence. The prescribing information includes warnings for differentiation syndrome, QTc prolongation, and Torsades de Pointes, and embryo-fetal toxicity. In November 2024, revumenib previously received approval for KMT2A-rearranged acute leukemia, and ongoing data continue to support its activity across genetically defined AML subsets.

FDA Grants Priority Review to Perioperative Enfortumab Vedotin Plus Pembrolizumab in Cisplatin-Ineligible MIBC

The regulatory agency has accepted and granted priority review to two supplemental biologics license applications (sBLAs) for enfortumab vedotin-ejfv (Padcev) plus pembrolizumab (Keytruda), or pembrolizumab and berahyaluronidase alfa-pmph (Keytruda Qlex), as perioperative therapy for cisplatin-ineligible muscle-invasive bladder cancer. The submissions are supported by findings from the phase 3 EV-303/KEYNOTE-905 trial (NCT03924895), where perioperative enfortumab vedotin plus pembrolizumab significantly improved event-free survival vs radical cystectomy plus pelvic lymph node dissection alone (HR, 0.40). The combination also demonstrated OS signals and a high pathologic complete response rate of 57.1% vs 8.6% with surgery alone. If approved, this would mark the first perioperative immunotherapy plus antibody-drug conjugate regimen available for this high-risk, cisplatin-ineligible population. Enfortumab vedotin plus pembrolizumab is already FDA approved in advanced urothelial cancer, reinforcing the combination’s expanding role across earlier disease settings.

FDA Accepts BLA Resubmission for RP1 Plus Nivolumab in Advanced Melanoma

The FDA has accepted the resubmitted biologics license application for vusolimogene oderparepvec (RP1) paired with nivolumab (Opdivo) for patients with advanced melanoma that has progressed on prior anti–PD-1 therapy, assigning a target action date of April 10, 2026. The resubmission addresses deficiencies cited in a complete response letter issued in July 2025, which stated that the phase 1/2 IGNYTE trial (NCT03767348) alone did not provide substantial evidence to support approval. Updated materials include additional analyses and responses aligned with FDA feedback following a Type A meeting. In IGNYTE, RP1 plus nivolumab elicited an objective response rate of 32.9% with a CR rate of 15.0% in evaluable patients (n = 140). The median duration of response was 33.7 months; 1- and 2-year OS rates were 73.5% and 63.3%, respectively. Safety remained manageable. Treatment-related AEs were reported in 90% of patients, but no treatment-related deaths occurred.

FDA Awards Breakthrough Therapy Designation to Bezuclastinib for Non-Advanced Systemic Mastocytosis

The FDA has granted breakthrough therapy designation to bezuclastinib (CGT9486) for use as a potential therapeutic option in patients with non-advanced systemic mastocytosis previously treated with avapritinib (Ayvakit), as well as for those with smoldering systemic mastocytosis—populations without approved standard-of-care therapies. The designation is supported by results from the phase 2 SUMMIT trial (NCT05186753), in which bezuclastinib significantly improved total symptom score and reduced serum tryptase levels compared with placebo. Most (87.4%) treated patients achieved reductions of at least 50% in serum tryptase, as well as improvements in KIT D816V allele burden, bone marrow mast cell aggregates, and clinically meaningful symptom reductions. Safety was manageable, with mostly low-grade AEs such as hair color changes and transient alanine aminotransferase/aspartate aminotransferase level elevations, leading to infrequent discontinuations (5.9%). A new drug application submission is planned by the end of 2025.