The OncFive: Top Oncology Articles for the Week of 1/4

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:

NDA Submitted to FDA for Rusfertide for Polycythemia Vera

A new drug application has been submitted to the FDA seeking approval of rusfertide for the treatment of adult patients with polycythemia vera based on findings from the phase 3 VERIFY trial (NCT05210790) and the phase 2 REVIVE study (NCT04057040). In part 1a of VERIFY, rusfertide met the primary end point and all key secondary end points in that it provided durable hematocrit control and reduced phlebotomy requirements vs placebo. At week 32, 76.9% of patients who were given rusfertide achieved a response vs 32.9% of those given placebo, and 62.6% maintained hematocrit levels below 45%. Updated 52-week data revealed sustained responses, including increased objective response rate (ORR) and durable control in patients who crossed over to rusfertide from the placebo arm.

Tafasitamab/Lenalidomide/R-CHOP Improves PFS vs R-CHOP Alone in First-Line DLBCL

The combination of tafasitamab-cxix (Monjuvi) plus lenalidomide (Revlimid) and R-CHOP (rituximab [Rituxan], cyclophosphamide, doxorubicin, vincristine, and prednisone) significantly improved investigator-assessed progression-free survival (PFS) vs R-CHOP alone in patients with newly diagnosed diffuse large B-cell lymphoma (DLBCL) in the phase 3 frontMIND trial (NCT04824092). The study met its primary end point of PFS (HR, 0.75; 95% CI, 0.59-0.96; P = .019) and its key secondary end point of event-free survival, with no new safety signals reported. Based on these data, Incyte, the developer of tafasitamab, shared plans to submit a supplemental biologics license application to the FDA in the first half of 2026. Tafasitamab previously received accelerated approval for use in combination with lenalidomide in those with relapsed/refractory DLBCL based on findings from the phase 2 L-MIND trial (NCT02399085).

FDA Grants Fast Track Designation for ETX-19477 in BRCA-Mutated, Platinum-Resistant HGSOC

The FDA has granted fast track designation to ETX-19477, a poly(ADP-ribose) glycohydrolase inhibitor, for patients with BRCA-mutated, platinum-resistant high-grade serous ovarian cancer. The designation was supported by preclinical findings and emerging clinical activity from the ongoing phase 1/2 ERADIC8 study (NCT06395519). ERADIC8 is examining ETX-19477 as a single agent using a dose-escalation and -expansion design in patients with BRCA-mutated solid tumors. The trial’s primary objectives include safety and tolerability, with preliminary efficacy assessed by RECIST 1.1 criteria.

Zoldonrasib Nets Breakthrough Therapy Designation in KRAS G12D–Mutated NSCLC

The FDA also granted breakthrough therapy designation to zoldonrasib (RMC-9805-001), a RAS(ON) G12D-selective inhibitor, for use in adult patients with KRAS G12D–mutated locally advanced or metastatic non–small cell lung cancer previously treated with anti–PD-1/PD-L1 therapy and platinum-based chemotherapy. The decision was supported by findings from the phase 1 RMC-9805-001 study (NCT06040541), in which patients who received zoldonrasib at 1200 mg daily experienced an ORR of 61% and a disease control rate of 89%. The median time to response was 1.4 months. Moreover, no grade 4 or 5 treatment-related adverse effects were observed. Zoldonrasib is being evaluated across several tumor types.

Q1 2026: 5 FDA Decisions to Watch in the Realm of Oncology

Several FDA regulatory decisions are anticipated in Q1 2026 across oncology, including potential action on tabelecleucel (Ebvallo) for Epstein-Barr virus–positive post-transplant lymphoproliferative disease based on findings from the phase 3 ALLELE trial (NCT03394365). Other anticipated decisions include pembrolizumab (Keytruda) plus chemotherapy with or without bevacizumab (Avastin) for platinum-resistant recurrent ovarian cancer, supported by data from the phase 3 KEYNOTE-B96/ENGOT-ov65 study (NCT05116189). The agency is also reviewing decitabine/cedazuridine (Inqovi) plus venetoclax (Venclexta) for newly diagnosed acute myeloid leukemia based on phase 2b ASCERTAIN-V (NCT04657081) findings, as well as imaging agents piflufolastat F 18 (CONDOR; NCT03739684) and gallium-68 edotreotide (LNTH-2501) for neuroendocrine tumors. These decisions could introduce new therapeutic and diagnostic options across hematologic malignancies and solid tumors.