The OncFive: Top Oncology Articles for the Week of 5/18

May 24, 2025

FDA’s ODAC voted on therapeutic approaches in lymphoma, bladder, prostate, and myeloma, and more from OncLive this week.

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 ODAC Votes Against the Applicability of STARGLO Data for Glofitamab Plus Chemo for U.S. Patients With R/R DLBCL

The FDA’s Oncologic Drugs Advisory Committee (ODAC) voted 8 to 1 against the applicability of the phase 3 STARGLO trial (NCT04408638) data to the US population for the treatment of relapsed/refractory diffuse large B-cell lymphoma with glofitamab-gxbm (Columvi) plus gemcitabine and oxaliplatin, citing concerns over regional heterogeneity and low US patient enrollment. Despite the study showing a survival benefit in the overall population, subgroup analyses revealed inconsistent efficacy across regions, with Asian patients showing the most pronounced benefit. FDA reviewers highlighted significant demographic and treatment baseline differences between Asian and non-Asian participants, raising doubts about generalizability to US practice. Genentech argued the results are applicable to US patients and pointed to multivariable analyses supporting overall survival (OS) consistency, but regulators emphasized the need for more US-based data before considering approval.

FDA’s ODAC Votes Against Risk/Benefit Profile of UGN-102 in Recurrent, Low-Grade, Intermediate-Risk NMIBC

The FDA’s ODAC voted narrowly, 5 to 4, against the risk/benefit profile of UGN-102 (mitomycin for intravesical solution) for recurrent, low-grade, intermediate-risk non–muscle-invasive bladder cancer, citing concerns over limited long-term data and reliance on single-arm trial design. The new drug application for UGN-102 was primarily supported by the ENVISION trial (NCT05243550), which showed a 3-month complete response rate of 79.6% and encouraging durability but lacked a randomized comparator. Committee members were split, with some endorsing UGN-102 as a promising, surgery-sparing option for select patients, while others emphasized the need for randomized evidence to confirm clinical benefit in this indolent disease. Despite the setback, UroGen Pharma remains in discussions with the regulatory agency, which previously acknowledged single-arm trials may be acceptable in this setting but continues to express a preference for randomized data.

FDA Votes Against Risk/Benefit Profile of Talazoparib Plus Enzalutamide for Non-HRR–Mutant mCRPC

The FDA’s ODAC voted unanimously against expanding approval of talazoparib (Talzenna) plus enzalutamide (Xtandi) for all patients with metastatic castration-resistant prostate cancer (mCRPC), citing insufficient evidence of benefit in those without homologous recombination repair (HRR) mutations. While the combo showed radiographic progression-free survival and OS benefits in HRR-mutated patients, the trial lacked formal evaluation in HRR-negative/unknown subgroups, raising concerns over efficacy and added toxicity. The agency emphasized the need for rigorously defined biomarker-negative populations in future trials to avoid overgeneralization. Broader oncology trials, like MAGNITUDE (NCT03748641), also failed to show PARP inhibitor benefit in non–HRR-mutated mCRPC, reinforcing a biomarker-driven approach to precision therapy.

FDA’s ODAC Votes in Favor of Risk/Benefit Profile of Subcutaneous Daratumumab for High-Risk Smoldering Myeloma

The FDA’s ODAC voted 6 to 2 in favor of the risk/benefit profile of subcutaneous daratumumab (daratumumab and hyaluronidase-fihj [Darzalex Faspro]) as monotherapy for high-risk smoldering multiple myeloma, based on results from the phase 3 AQUILA trial (NCT03301220). AQUILA showed a significant progression-free survival (PFS) benefit, although the FDA raised concerns about variability in high-risk definitions and the clinical relevance of PFS as the primary end point. Safety concerns included higher rates of infections and adverse effects in the treatment arm, while patient-reported outcomes data were deemed inconclusive due to trial limitations. Despite these concerns, patient advocates and several committee members emphasized the need for an approved treatment option in this underserved population.

Artificial Intelligence Proves Its Worth in Cancer Treatment, Drug Development, and Other Real-World Applications

Artificial intelligence (AI) is increasingly transforming cancer care, with current applications improving treatment selection, easing administrative burdens, and enhancing drug development. Real-world uses include machine learning models that predict transplant outcomes, tools that extract structured data from electronic health records, and systems that accelerate clinical decision-making. Despite its promise, experts highlight ongoing concerns such as algorithmic bias and the need for diverse data to ensure equity and accuracy in patient care. Looking ahead, AI is poised to impact nearly every facet of oncology, with ongoing research focused on expanding its role in diagnosis, treatment planning, and research validation. Sign up to access this exclusive feature, packed full of expert insights.

Honorable mentions:

Ahead of the 2025 ASCO Annual Meeting, leading hematologic oncology experts shared the abstracts they’re most eager to see, highlighting potentially practice-changing data in polycythemia vera, diffuse large B-cell lymphoma, T-cell lymphoma, and CAR T-cell therapies.
Leading gynecologic oncology experts previewed key abstracts ahead of the meeting, spotlighting promising new data across ovarian and cervical cancers—ranging from novel combination therapies and first-line immunotherapy approaches to the use of circulating tumor DNA for monitoring relapse risk.
Leading gastrointestinal cancer experts shared their perspectives on over 10 key studies poised to impact clinical practice, spanning advances in immunotherapy, targeted treatments, and combination regimens across colorectal, gastric, pancreatic, and esophageal cancers.
Genitourinary oncology experts preview several key abstracts at the upcoming meeting that could advance treatment standards and refine biomarker-driven care across prostate, bladder, kidney, and testicular cancers.