The OncFive: Top Oncology Articles for the Week of 1/12

Welcome to OncLive®’s OncFive!

Every week, we will compile the top 5 stories in oncology, ranging from pivotal regulatory decisions to news updates and expert interviews spanning tumor types. Here’s what you may have missed this week:

FDA Approves Sotorasib Plus Panitumumab for KRAS G12C–Mutated Colorectal Cancer

The regulatory agency cleared the combination of sotorasib (Lumakras) and panitumumab (Vectibix) for use in adult patients with KRAS G12C–mutated metastatic colorectal cancer who had prior fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy based on findings from the phase 3 CodeBreaK 300 trial (NCT05198934). Those who received 960 mg of sotorasib plus panitumumab (n = 53) experienced a 52% reduction in the risk of disease progression or death vs investigator’s choice of trifluridine/tipiracil (Lonsurf) or regorafenib (Stivarga; n = 54; HR, 0.48; 95% CI, 0.3-0.78; P = .005).

FDA OKs Acalabrutinib Plus Bendamustine/Rituximab for Previously Untreated MCL

Acalabrutinib (Calquence) combined with bendamustine and rituximab (Rituxan; BR) was approved by the FDA for use in adult patients with previously untreated mantle cell lymphoma who were not candidates for transplant based on findings from the phase 3 ECHO trial (NCT02972840). The median progression-free survival was 66.4 months (95% CI, 55.1-not estimable) with the triplet (n = 299) vs 49.6 months (95% CI, 36.0-64.1) with placebo/BR (n = 299), translating to a 27% reduction in the risk of disease progression or death (HR, 0.73; 95% CI, 0.57-0.94; P = .016).

Dato-DXd Receives FDA Priority Review in Pretreated EGFR-Mutated NSCLC

The regulatory agency granted priority review to the biologics license application (BLA) seeking the approval of datopotamab deruxtecan for use in adult patients with locally advanced or metastatic EGFR-mutated non–small cell lung cancer who previously received systemic therapies, including an EGFR-targeted therapy. The BLA is supported by data from the following studies: phase 2 TROPION-Lung05 (NCT04484142), phase 3 TROPION-Lung 01 (NCT04656652), and phase 1 TROPION-PanTumor01 (NCT03401385). Under the Prescription Drug User Fee Act (PDUFA), the target action date was July 12, 2025.

FDA Approval of Subcutaneous Nivolumab Represents Paradigm Shift in Solid Tumor Management

In an exclusive interview with OncLive, Roxana S. Dronca, MD, a hematologist/oncologist and chair of the Department of Hematology/Oncology at the Mayo Clinic Comprehensive Cancer Center, discussed the FDA approval of nivolumab and hyaluronidase-nvhy (Opdivo Qvantig) across approved solid tumor indications. She highlighted how the decision represents a significant shift in cancer management, spotlighted the data that supported the approval, and explained how the continued development of subcutaneous approaches could impact care.

PDUFA Date Set for 3-Month Variation of Leuprolide Mesylate in Advanced Prostate Cancer

The regulatory agency issued a day-75 letter stating that the goal date under the PDUFA regarding the marketing approval for the 3-month, 21-mg variation of leuprolide mesylate (Camcevi) for use in adult patients with advanced prostate cancer will be August 29, 2025. The application is based on data from a phase 3 trial (NCT03261999).

Honorable Mention: FDA Approves Datopotamab Deruxtecan for Unresectable or Metastatic HR+/HER2-Negative Breast Cancer

Datopotamab deruxtecan-dlnk (Datroway) was cleared by the FDA for the treatment of adult patients with unresectable or metastatic hormone receptor–positive, HER2-negative breast cancer who have previously received endocrine-based therapy and chemotherapy for unresectable or metastatic disease.