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The OncFive: Top Oncology Articles for the Week of 6/29

The FDA grants approval to sunvozertinib in NSCLC and linvoseltamab in myeloma and removes REMS requirements for approved CAR T-cell therapies.

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:

Top Articles of the Week: #1

Top Articles of the Week: #1

FDA Grants Accelerated Approval to Sunvozertinib for Metastatic NSCLC With EGFR Exon 20 Insertion Mutations

The FDA has granted accelerated approval to sunvozertinib (Zegfrovy) for the treatment of adults with locally advanced or metastatic non–small cell lung cancer (NSCLC) harboring EGFR exon 20 insertion mutations whose disease progressed following platinum-based chemotherapy. The decision was based on data from the phase 1b WU-KONG1 trial (NCT03974022), in which the 200-mg daily dose achieved a confirmed objective response rate (ORR) of 46% and a median duration of response (DOR) of 11.1 months. Most treatment-related adverse effects were grade 1 or 2 and clinically manageable, although some grade 3 or higher effects, such as diarrhea and elevated creatine phosphokinase levels, were reported. The prescribing information includes warnings for interstitial lung disease/pneumonitis, gastrointestinal and dermatologic toxicity, and ocular effects. Concurrently, the regulatory agency cleared the Oncomine Dx Express Test as a companion diagnostic for detecting eligible EGFR exon 20 insertion mutations.

Top Articles of the Week: #2

Top Articles of the Week: #2

FDA Approves Linvoseltamab for Relapsed/Refractory Multiple Myeloma

The FDA has granted accelerated approval to linvoseltamab-gcpt (Lynozyfic), a BCMA-directed CD3 T-cell engager, for adult patients with relapsed or refractory multiple myeloma after at least four prior lines of therapy. Approval was based on results from the phase 1/2 LINKER-MM1 trial (NCT03761108), which showed a 70% ORR, including a 45% complete response rate, with durable responses and a median time to first response of less than one month. At a median follow-up of 11.3 months, the estimated 12-month DOR rate was 72%. The therapy’s response-adapted dosing schedule may reduce treatment burden for patients. The prescribing label includes a Boxed Warning for cytokine release syndrome (CRS) and neurologic toxicity, and most adverse effects (AEs) were manageable, although serious events occurred in a subset of patients.

Top Articles of the Week: #3

Top Articles of the Week: #3

FDA Removes REMS Programs for All Currently Approved CD19- and BCMA-Directed CAR T-Cell Therapies in Hematologic Malignancies

The FDA has removed the Risk Evaluation and Mitigation Strategies requirements for all currently approved BCMA- and CD19-directed autologous CAR T-cell therapies used in hematologic malignancies. This decision applies to agents such as idecabtagene vicleucel (Abecma), lisocabtagene maraleucel (Breyanzi), ciltacabtagene autoleucel (Carvykti), tisagenlecleucel (Kymriah), brexucabtagene autoleucel (Tecartus), and axicabtagene ciloleucel (Yescarta), which will still carry boxed warnings for CRS and neurologic toxicity. The FDA cited growing provider experience and data showing that most AEs occur within the first 2 weeks post-infusion as reasons for the policy shift. In addition, post-treatment monitoring requirements were eased, including reduced proximity-to-center mandates and shortened driving restrictions. Manufacturers are still required to conduct 15-year post-marketing safety studies to monitor long-term risks such as secondary malignancies.

Top Articles of the Week: #4

Top Articles of the Week: #4

OncLive’s FDA Approval Report: The Regulatory Rundown for June 2025

In June 2025, the FDA approved several significant oncology therapies across solid tumors and hematologic malignancies. Highlights include darolutamide (Nubeqa) for metastatic castration-sensitive prostate cancer based on ARANOTE (NCT04736199) data, taletrectinib (Ibtrozi) for ROS1+ NSCLC offering strong systemic and intracranial activity, and a tablet formulation of zanubrutinib (Brukinsa) simplifying dosing for B-cell malignancies. Additional approvals included intravesical mitomycin (UGN-102; Zusduri) for non–muscle-invasive bladder cancer, perioperative pembrolizumab (Keytruda) for PD-L1–positive resectable head and neck squamous cell carcinoma, and a triplet of tafasitamab-cxix (Monjuvi), lenalidomide (Revlimid), and rituximab (Rituxan) for relapsed/refractory follicular lymphoma. The month also saw the accelerated approval of datopotamab deruxtecan (Dato-DXd; Datroway) in pretreated EGFR-mutant NSCLC, addressing a key unmet need. These approvals reflect growing precision in targeting, convenience in formulation, and shifts toward non-surgical and perioperative strategies across cancer types. Sign up to access the full resource.

Top Articles of the Week: #5

Top Articles of the Week: #5

First-Line Bemarituzumab Plus Chemo Hits OS End Point in FGFR2b+ Advanced Gastric Cancer

In the phase 3 FORTITUDE-101 trial (NCT05052801), the addition of bemarituzumab to mFOLFOX6 (modified oxaliplatin, leucovorin, and fluorouracil) significantly improved overall survival compared with placebo plus chemotherapy in patients with HER2-negative, FGFR2b-overexpressing, unresectable or metastatic gastric or gastroesophageal junction cancer. The trial met its primary end point, marking the first positive phase 3 results for an FGFR2b-targeted monoclonal antibody in this setting. AEs reported in over 25% of patients receiving bemarituzumab included ocular events (e.g., reduced visual acuity, punctate keratitis, dry eye) as well as anemia and neutropenia, consistent with prior data but more frequent and severe in the experimental arm. These findings underscore a potential new targeted option for a population with limited therapies and poor prognosis. Further data from FORTITUDE-101 and the ongoing FORTITUDE-102 trial (NCT05111626)—which is evaluating bemarituzumab plus chemotherapy and nivolumab (Opdivo)—are anticipated later in 2025.


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