The Targeted Pulse: Hot Off-The-Press Approvals and What to View from ASCO GU 2025

Vimseltinib Is Now Approved For Symptomatic Tenosynovial Giant Cell Tumor

Vimseltinib (DCC-3014) has received FDA approval for the treatment of symptomatic tenosynovial giant cell tumor. Vimseltinib is a colony-stimulating factor 1 receptor (CSF1R) inhibitor. This approval is based on the results of the 2-part, randomized, double-blind, placebo-controlled phase 3 MOTION study (NCT05059262). In this trial, patients were randomly assigned in a 2:1 ratio to receive either 30 mg of vimseltinib twice weekly (the recommended dose, with a minimum 72-hour interval between doses) or placebo for 25 weeks.

The agent demonstrated significant improvements compared with placebo, with most treatment-emergent adverse events classified as grade 1 or 2. For more details on the data supporting the approval, access the full article here.

177Lu-PSMA-617 With Enzalutamide Elicits 8-Month OS Benefit in mCRPC

The addition of [177Lu]Lu-PSMA-617 (LuPSMA; Pluvicto) to enzalutamide (Xtandi) improved both overall survival (OS) and quality of life (QOL) in patients with metastatic castration-resistant prostate cancer (mCRPC). The phase 2 ENZA-p trial (NCT04419402) evaluated this combination vs enzalutamide alone in patients with mCRPC who were at high risk for early treatment failure. These data were presented at the 2025 ASCO Genitourinary Cancers Symposium in San Francisco, California.

“The significant OS benefit observed and the QOL improvements really raises the question of whether PSMA radioligand therapy in prostate cancer should be administered more broadly in conjunction with androgen receptor pathway inhibitors. This paves the way for phase 3 trials leveraging these complementary therapies across the prostate cancer space,” Louise Emmett, MD, FRACP, director of theranostics and nuclear medicine at St Vincent’s Hospital in Sydney, Australia, said during a presentation of the data. For further information on the trial data, access the complete article here.

A Complete Guide of ASCO GU 2025 for The Community Oncologist

In this article, the staff of Targeted Oncology™ highlight key data presented at the 2025 ASCO Genitourinary Cancers Symposium that are most relevant to clinicians in community settings. The article covers new data on several genitourinary cancer types, including prostate, kidney, bladder, and testicular and penile cancers, providing a summary of the findings, along with links to full coverage and roundtable discussions. Explore these important updates in a comprehensive package designed with you in mind.

To access this information, we ask you to share more details about yourself so we can better tailor our offerings. Begin hereto get started and access this resource.

TDM-1: “First Therapy to Show Improved OS After Postsurgical Therapy” in HER+ BC

Ado-trastuzumab emtansine (T-DM1; Kadcyla) continues to show improved OS and invasive disease–free survival compared with trastuzumab (Herceptin) in HER2-positive early breast cancer, with 8.4 years of follow-up. These updated findings from the KATHERINE trial (NCT01772472) involved patients with residual invasive disease after neoadjuvant therapy and were presented at the 2024 San Antonio Breast Cancer Symposium in Texas.

“TDM-1 is the first therapy to show an improved survival after postsurgical therapy in patients with HER2-positive early breast cancer and residual invasive disease after neoadjuvant therapy,” study author Sibylle Loibl, MD, PhD, of the German Breast Group in Neu-Isenburg, the Centre for Haematology and Oncology Bethanien in Frankfurt, and Goethe University of Frankfurt, all in Germany, said in a presentation of the findings. For more info on trial data, access the full article here.

Brentuximab Vedotin/Lenalidomide/Rituximab Scores Approval in R/R LBCL

The combination of brentuximab vedotin (Adcetris), lenalidomide (Revlimid), and rituximab (Rituxan) has received FDA approval for the treatment of relapsed or refractory large B-cell lymphoma. The indication also includes diffuse large B-cell lymphoma (DLBCL) not otherwise specified, DLBCL arising from indolent lymphoma, or high-grade B-cell lymphoma in patients who have received at least 2 lines of systemic therapy and are ineligible for autologous hematopoietic stem cell transplantation or chimeric antigen receptor T-cell therapy.

This approval is based on data from the phase 3 ECHELON-3 study (NCT04404283). In this randomized, double-blind, placebo-controlled trial, 230 adult patients were assigned 1:1 to receive either brentuximab vedotin/lenalidomide/rituximab or placebo/lenalidomide/rituximab until disease progression or unacceptable toxicity. For more information on trial data and recommended dose, access the full article here.

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