The OncFive: Top Oncology Articles for the Week of 9/14

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:

Path Toward Accelerated Approval of RP1 in Advanced Melanoma Remains Unclear After FDA Type A Meeting

After the FDA issued a complete response letter (CRL) in July 2025 regarding a biologics license application seeking the approval of RP1 in combination with nivolumab (Opdivo) for the treatment of adults with advanced melanoma who have previously received a PD-1 inhibitor–containing regimen, the regulatory agency completed a Type A meeting with Replimune, the developer of the oncolytic virus therapy.

Replimune announced that following the meeting, the company is reviewing feedback from the FDA. At this time, a path toward accelerated approval of the RP1-based combination has not been determined. The CRL cited issues with the phase 1/2 IGNYTE trial (NCT03767348), which the FDA said did not meet the threshold to be considered an adequate and well-controlled clinical investigation to produce substantial evidence supporting approval.

New AACR Cancer Progress Report Spotlights Notable Gains, Ongoing Challenges in Research

On Wednesday, the American Association for Cancer Research (AACR) published its 15th edition of its Annual Cancer Progress Report, highlighting recent advances in cancer care and ongoing challenges with treatment and research.

Particularly, AACR reviewed the plethora of drugs to receive regulatory approval between July 2024 and June 2025. The organization also highlighted falling rates of cancer-related mortality from 1991 to 2023, underscoring the progress made with treatments and the growing number of cancer survivors living in the United States and around the world.

Additionally, the report focused on the importance of federal funding for medical research, including oncology-related work.

Targeted Therapies Drive Demand for Comprehensive Biomarker Testing in NSCLC

With targeted therapies continuing to enter and reshape the treatment paradigm in non–small cell lung cancer (NSCLC), experts sat down with OncLive to discuss the paramountcy of molecular testing as a part of routine care for this patient population.

Benjamin P. Levy, MD; Joel Neal, MD, PhD; and Christian Rolfo, MD, PhD detailed the current state of testing in practice, the modalities used for molecular testing in NSCLC, the growing role of liquid biopsies, and best practices for testing.

“[Now] couldn’t be a more important time to do biomarker testing in patients with lung cancer,” Levy said.

FDA Grants Breakthrough Therapy Designation to R-DXd in CDH6-Expressing Ovarian Cancer

The FDA granted breakthrough therapy designation to raludotatug deruxtecan (R-DXd), a potential first-in-class CDH6-directed antibody-drug conjugate (ADC), for the treatment of adult patients with platinum-resistant epithelial ovarian, primary peritoneal, or fallopian tube cancers expressing CDH6 who have received prior treatment with bevacizumab (Avastin).

The designation was supported by data from a phase 1 trial (NCT04707248) evaluating R-DXd in patients with advanced ovarian tumors, along with findings from the ongoing phase 2/3 REJOICE-Ovarian01 trial (NCT06161025) investigating the ADC in patients with platinum-resistant, high-grade ovarian, primary peritoneal, or fallopian tube cancer.

European Commission Greenlights Vimseltinib for Symptomatic, Unresectable TGCT

The European Commission approved vimseltinib (Romvimza) for the treatment of adult patients with symptomatic tenosynovial giant cell tumor (TGCT) associated with clinically relevant physical function deterioration and in whom surgical options have been exhausted or would induce unacceptable morbidity or disability.

The approval was supported by data from the phase 3 MOTION trial (NCT05059262) and a phase 1/2 trial (NCT03069469).

Honorable Mention: The 22nd International Myeloma Society Annual Meeting took place September 17 to 20, 2025, in Toronto, Canada, highlighting key advances in multiple myeloma research. Check this page to see OncLive's extensive coverage of the meeting.