The OncFive: Top Oncology Articles for the Week of 3/1

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 Teclistamab Plus Subcutaneous Daratumumab for Relapsed/Refractory Multiple Myeloma

The FDA approved teclistamab-cqyv (Tecvayli) plus daratumumab and hyaluronidase-fihj (Darzalex Faspro) for the treatment of adult patients with relapsed/refractory multiple myeloma who have previously received at least 1 line of therapy. The agency also converted the approval of teclistamab monotherapy for use in patients with relapsed or refractory multiple myeloma to traditional status. The decision was supported by findings from the phase 3 MajesTEC-3 trial (NCT05083169), which showed a significant improvement in progression-free survival (PFS) with teclistamab plus daratumumab (n = 291) vs investigator’s choice of daratumumab-based regimens (HR, 0.17; 95% CI, 0.12-0.23; P < .0001). The combination elicited an overall response rate of 89.0% and a complete response or better rate of 81.8%, as well as higher minimal residual disease negativity rates (58.4% vs 17.1%; OR, 6.78; P < .0001). Safety was in line with known profiles, with common adverse effects such as neutropenia, cytokine release syndrome, diarrhea, and cough.

FDA Approves Pylarify TruVu for PSMA-PET Imaging in Prostate Cancer

The FDA cleared Pylarify TruVu (piflufolastat F 18) for PET imaging of prostate-specific membrane antigen (PSMA)–positive lesions in men with prostate cancer with suspected metastasis or recurrence. The decision was based on data from the phase 2/3 OSPREY (NCT02981368) and the phase 3 CONDOR (NCT03739684) studies, which demonstrated high specificity and accurate lesion localization with PSMA-targeted PET imaging. In cohort A of OSPREY, the imaging agent showed strong specificity (97.9% vs 65.1%) and positive predictive value (86.7% vs 28.3%) for detecting pelvic lymph node metastases vs standard imaging. Findings from CONDOR indicated that a PSMA-targeted PET scan with piflufolastat F 18 in those with biochemical recurrent disease had a correct localization rate ranging from 85% to 87%, spanning all three readers (95% CI, 78%-80%), which met the primary end point of the study. The new formulation is designed to improve manufacturing efficiency and distribution, potentially expanding patient access to advanced PSMA PET diagnostics.

Lutetium Lu 177 Dotatate Radioequivalent Receives Tentative FDA Approval for SSTR+ GEP-NETs

The FDA also granted tentative approval to the abbreviated new drug application for PNT2003, a lutetium Lu 177 dotatate radioequivalent for the treatment of patients with somatostatin receptor (SSTR)–positive gastroenteropancreatic neuroendocrine tumors (NETs). The decision positions PNT2003 as the first radioequivalent to Lutathera, although full approval is contingent on the expiration of a 30-month regulatory stay expected in June 2026. Evidence from the OZM-067 trial (NCT02743741) showed a 12-month PFS rate of 81% (95% CI, 75%-86%) and an overall survival (OS) rate of 92% (95% CI, 87%-95%) in patients with SSTR-positive NETs. These data highlight the growing role of targeted radiopharmaceutical therapies in neuroendocrine tumor management.

FDA Grants Priority Review to Rusfertide in Polycythemia Vera

The FDA granted priority review to a new drug application for rusfertide (PTG-300) for the treatment of adult patients with polycythemia vera, with a target decision expected in the third quarter of 2026. The application is supported primarily by findings from the phase 3 VERIFY trial (NCT05210790), which showed significantly higher clinical response rates with rusfertide plus standard of care (n = 147) vs placebo plus standard therapy (n = 146; 76.9% vs 32.9%; P < .0001). Those who received rusfertide also required fewer phlebotomies and maintained hematocrit levels below 45% from baseline to week 32 more frequently. Additional supporting findings came from the phase 2 REVIVE trial (NCT04057040) and the ongoing phase 3 THRIVE extension study (NCT06033586).

sNDA Seeking Approval of Belzutifan Plus Pembrolizumab in ccRCC Earns Priority Review From FDA

The FDA granted priority review to supplemental applications seeking approval of belzutifan (Welireg) plus pembrolizumab (Keytruda) or pembrolizumab with berahyaluronidase alfa for adjuvant treatment of patients with high-risk clear cell renal cell carcinoma (ccRCC) after nephrectomy. The filings are supported by data from the phase 3 LITESPARK-022 trial (NCT05239728), which showed improved disease-free survival (DFS) with pembrolizumab plus belzutifan (n = 921) vs pembrolizumab alone (n = 920; HR, 0.72; 95% CI, 0.59-0.87; P = .0003). At interim analysis, the combination demonstrated higher 12- (91.9% vs 85.2%), 24- (80.7% vs 73.7%), and 30- (75.8% vs 68.6%) month DFS rates vs monotherapy. OS data remain immature, and the FDA has set a decision date of June 19, 2026, under the Prescription Drug User Fee Act.

Honorable Mentions:

• Early-onset colorectal cancer is rapidly emerging as a clinical crisis—nearly doubling since the 1990s and now the leading cause of cancer-related death in adults under 50 years—driven by largely sporadic disease in otherwise healthy individuals and underscoring an urgent need for deeper research into its biology, environmental drivers, and earlier detection strategies. Sign up to read the exclusive feature, which comprises insights from John L. Marshall, MD, of Georgetown University Lombardi Comprehensive Cancer Center, and Christopher Lieu, MD, of University of Colorado Anschutz Cancer Center.
• The 43rd Annual Miami Breast Cancer Conference spotlights how rapidly evolving data, from antibody-drug conjugates and axillary management strategies to the emerging role of circulating tumor DNA, can be translated into real-world clinical decisions for patients with breast cancer. In this exclusive interview with OncLive®, Hope S. Rugo, MD, FASCO, of City of Hope, highlights the top presentations from the meeting.
• This exclusive regulatory roundup spotlights all the oncologic options that were given the green light by the FDA in February 2026. Sign up to access this cheat sheet, which includes topline data that supported the decisions and expert insights detailing clinical practice implications.
• February 2026 brought a wave of key regulatory updates in breast cancer, highlighted by priority review for datopotamab deruxtecan-dlnk (Datroway) in metastatic triple-negative breast cancer, a potential new approval pathway for giredestrant plus everolimus (Afinitor) in ESR1-mutated tumors, and new fast track and breakthrough designations advancing targeted treatment strategies.
• At the 2026 Genitourinary Cancers Symposium, emerging data highlighted potential practice-changing advances across RCC, bladder cancer, and prostate cancer, including adjuvant belzutifan plus pembrolizumab improving DFS in ccRCC, enfortumab vedotin-ejfv (Padcev) plus pembrolizumab enhancing event-free outcomes in muscle-invasive bladder cancer, and enzalutamide (Xtandi) with radium-223 (Xofigo) extending OS in metastatic castration-resistant prostate cancer.