The OncFive: Top Oncology Articles for the Week of 7/19

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 Accepts NDA for Daraxonrasib in Previously Treated Metastatic Pancreatic Cancer

The FDA accepted a new drug application seeking approval of daraxonrasib (RMC-6236), an oral RAS(ON) multiselective inhibitor, for patients with previously treated metastatic pancreatic ductal adenocarcinoma. The agent was selected for the FDA Commissioner’s National Priority Voucher pilot program, which is anticipated to shorten the review to 1 to 2 months.

The application is based on the phase 3 RASolute 302 trial (NCT06625320), which met its dual primary end points of overall survival (OS) and progression-free survival (PFS) in the RAS G12–mutant population; at the first interim analysis presented at the 2026 ASCO Annual Meeting, daraxonrasib produced a median OS of 13.2 months vs 6.6 months with investigator’s choice chemotherapy in that group.

FDA Approves Zidesamtinib in Pretreated ROS1+ NSCLC

The FDA approved zidesamtinib (Jideytro) for adult patients with locally advanced or metastatic ROS1-positive non–small cell lung cancer who received a prior ROS1 kinase inhibitor.

The approval is supported by the phase 1/2 ARROS-1 trial (NCT05118789), in which the confirmed overall response rate was 44% (95% CI, 34%-53%) in the overall population (n = 117), including a 0.9% complete response rate. The 6- and 12-month duration of response rates were 82% and 69%, respectively.

FDA Grants Priority Review to Talazoparib Plus Enzalutamide in HRR-Altered mCSPC

The FDA accepted for priority review a supplemental new drug application for talazoparib (Talzenna) plus enzalutamide (Xtandi) in men with homologous recombination repair (HRR) gene-altered metastatic castration-sensitive prostate cancer, with a PDUFA action date set for the fourth quarter of 2026.

The filing is supported by the phase 3 TALAPRO-3 trial (NCT04821622), in which the combination reduced the risk of radiographic progression or death by 52% vs placebo plus enzalutamide (HR, 0.48; 95% CI, 0.36-0.65; P < .0001).

Teclistamab Plus Talquetamab Yields Significant Survival Benefits in Earlier-Line R/R Myeloma

Topline results from the phase 3 MonumenTAL-6 trial (NCT06208150) showed that the bispecific antibody combination of teclistamab-cqyv (Tecvayli) and talquetamab-tgvs (Talvey) significantly improved PFS and OS vs investigator’s choice of standard-of-care therapy in patients with relapsed/refractory multiple myeloma who had received 1 to 4 prior lines.

Per Johnson & Johnson, the combination reduced the risk of disease progression or death by 89% (HR, 0.11; 95% CI, 0.08-0.16; P < .0001) and the risk of death by 62% (HR, 0.38); a second investigational arm of talquetamab plus pomalidomide also met its primary end point.

CHMP Recommends T-DXd Plus Pertuzumab for First-Line HER2-Positive Metastatic Breast Cancer

The Committee for Medicinal Products for Human Use of the European Medicines Agency recommended EU approval of fam-trastuzumab deruxtecan-nxki (T-DXd; Enhertu) plus pertuzumab (Perjeta) for the first-line treatment of unresectable or metastatic HER2-positive breast cancer. The recommendation is based on the phase 3 DESTINY-Breast09 trial (NCT04784715), in which the regimen reduced the risk of disease progression or death by 44% vs a taxane, trastuzumab, and pertuzumab (HR, 0.56; 95% CI, 0.44-0.71; P < .00001).