The OncFive: Top Oncology Articles for the Week of 2/8

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 Pembrolizumab Plus Paclitaxel With/Without Bevacizumab for PD-L1+ Platinum-Resistant Ovarian Cancer

The FDA approved pembrolizumab (Keytruda) and pembrolizumab/berahyaluronidase alfa-pmph (Keytruda Qlex) plus paclitaxel, with or without bevacizumab (Avastin), for PD-L1–positive (combined positive score of 1 or higher) platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal carcinoma following 1 to 2 previous therapies. The decision was supported by findings from the phase 3 KEYNOTE-B96 trial (NCT05116189). In PD-L1–positive tumors, pembrolizumab significantly improved median progression-free survival (PFS) vs placebo, at a median of 8.3 months (95% CI, 7.0-9.4) and 7.2 months (95% CI, 6.2-8.1), respectively (HR, 0.72; 95% CI, 0.58-0.89; P = .0014); pembrolizumab also significantly improved overall survival (OS) over placebo, at a median of 18.2 months (95% CI, 15.3-21.0) and 14.0 months (95% CI, 12.5-16.1), respectively (HR, 0.76; 95% CI, 0.61-0.94; P = .0053). The regulatory agency also cleared the PD-L1 IHC 22C3 pharmDx assay as a companion diagnostic.

FDA Approves Optune Pax for Locally Advanced Pancreatic Cancer

The FDA approved Optune Pax for use with gemcitabine and nab-paclitaxel (Abraxane) in adult patients with locally advanced pancreatic cancer. The decision was based on data from the phase 3 PANOVA-3 trial (NCT03377491), which met its primary end point of improved OS. In the intention-to-treat population, the median OS was 16.2 months (95% CI, 15.0-18.0) with Optune Pax (n = 285) vs 14.2 months (95% CI 12.8-15.4) with chemotherapy alone (n = 286; HR, 0.82; 95% CI 0.68-0.99; P = 0.039), with greater benefit observed in protocol-adherent patients. The device improved time to pain progression and quality-of-life measures without increasing systemic toxicity.

FDA Accepts sNDA Filing of Aminolevulinic Acid Topical Gel for Superficial Basal Cell Carcinoma

The FDA accepted a supplemental new drug application seeking approval of aminolevulinic acid (Ameluz) topical gel plus the RhodoLED red light lamp series for superficial basal cell carcinoma (BCC), assigning a Prescription Drug User Fee Action date of September 28, 2026. If cleared, it would be the first photosensitizer indicated for superficial BCC in the United States. The application is supported by a phase 3 trial (NCT03573401) showcasing significantly higher composite clinical and histological clearance vs vehicle control, at 65.5% and 4.8%, respectively (P < .0001). Safety data proved to be consistent with known photodynamic therapy–related local reactions.

FDA Guidance Signals Shift Toward MRD-Driven Accelerated Approvals in Multiple Myeloma

In January 2026, the FDA issued draft guidance supporting the use of minimal residual disease (MRD) and complete response as end points for accelerated approval in multiple myeloma. The guidance follows a unanimous 12-to-0 Oncologic Drugs Advisory Committee vote endorsing MRD as a valid surrogate marker for survival outcomes. The regulatory agency emphasized that randomized trials remain preferred and that MRD should not replace traditional end points such as PFS or OS. Previous trials integrating MRD, including CEPHEUS (NCT03652064), have already supported regulatory approvals such as daratumumab and hyaluronidase-fihj (Darzalex Faspro) plus bortezomib (Velcade), lenalidomide (Revlimid), and dexamethasone. Sign up to read this exclusive feature, which includes insights from Rahul Banerjee, MD, FACP, of Fred Hutch Cancer Center and the University of Washington, and Marc J. Braunstein, MD, PhD, of NYU Grossman Long Island School of Medicine.

Prostate Cancer Experts Preview Trials to Watch at ASCO GU 2026

Experts anticipate key prostate cancer readouts at the 2026 Genitourinary Cancers Symposium (ASCO GU) that may refine treatment intensification strategies across disease states. Notable trials include PEACE-2 (NCT01952223), evaluating androgen deprivation therapy and radiotherapy with or without cabazitaxel in very–high-risk localized disease, and PSMAddition (NCT04720157), assessing lutetium Lu 177 vipivotide tetraxetan (Pluvicto) in metastatic hormone-sensitive prostate cancer (mHSPC). Patient-reported outcomes from CAPItello-281 (NCT04493853) will inform tolerability of capivasertib (Truqap) plus abiraterone acetate (Zytiga) in PTEN-deficient mHSPC. Final OS data from PEACE-3 (NCT02194842) are expected to clarify the role of enzalutamide (Xtandi) plus radium-223 (Xofigo) in metastatic castration-resistant prostate cancer with bone metastases.

Sign up to access this exclusive conference preview, in which experts like Axel Merseburger, MD, PhD, of University Hospital Schleswig-Holstein and Guru Sonpavde, MD, of AdventHealth Cancer Institute, share the topics they most anticipate.

Honorable Mention

In two exclusive previews, experts highlight key renal cell carcinoma studies and top urothelial cancer topics they are most excited to learn more about at ASCO GU.