In the News: Top FDA Meetings, Decisions, and Actions in Cancer Care

Updates on treatments like vusolimogene oderparepvec for advanced melanoma, and novel therapies have been provided by the FDA.

After a long Labor Day Weekend, the FDA has made a number of decisions regarding various oncology treatments and has set meetings with a few developers regarding the future of these treatments. Highlights include an update on vusolimogene oderparepvec plus nivolumab (Opdivo) for advanced melanoma, an investigational new drug application for advanced solid tumors, and an AI-driven drug discovery. Read on to learn more about these recent updates.

#1 FDA Announces Type A Meeting for Vusolimogene Oderparepvec

A Type A meeting has been scheduled to discuss the complete response letter (CRL) regarding the biologics license application given to vusolimogene oderparepvec plus nivolumab for advanced melanoma in July 2025.¹ The CRL was provided because the FDA noted results from the phase 1/2 IGNYTE trial (NCT03767348) were not adequate to provide evidence of effectiveness.²

In response, the drug’s developer has submitted a briefing book to highlight points from the CRL, prior agreements that are related to the patient population, criteria for PD-1 resistance, and literature to support the contribution of components. In addition, the book includes an additional analysis of data from the BLA and addresses comments made about the phase 3 trial design.

#2 Investigational New Drug Application for AVZO-103 in Solid Tumors

The FDA has given clearance to a new drug application of AVZO-103 (formerly VAC-103) for patients with solid tumors.³ AVZO-103 is a potential best-in-class Nectin4/TROP2 bispecific antibody drug conjugate. A first-in-human phase 1/2 trial will be initiated under this acceptance.

In the phase 1 portion of the trial, the safety and tolerability, plus preliminary clinical activity of AVZO-103 as a single agent and in combination therapy, will be assessed.

#3 End of Phase 2 Meeting Discussed OST-HER2 in Advanced Osteosarcoma

The FDA conducted an End of Phase 2 Meeting with the developers of OST-HER2 to discuss the drug’s use in recurrent, fully resected, pulmonary metastatic osteosarcoma.⁴ A rolling submission of a BLA for the company’s Metastatic Osteosarcoma Program is slated for September 2025.

Based on the meeting, there are no significant safety concerns with OST-HER2, minimal fallow-up and non-clinical matters were agreed upon, and clear guidance was given to support the BLA approval.

#4 FDA Distances From Animal Testing, Turns to AI

The FDA has stated there should be a reduction in animal testing in the near future following the emergence of artificial intelligence (AI) options.⁵ According to a feature from Reuters, AI-based drug discovery testing took an average of 18 months to move a molecule into clinical testing compared with the average of 42 months.

Within 3 to 5 years, the FDA plans to better utilize AI-driven technologies, apart from pre-clinical safety and toxicity testing. With this change, the agency is hoping this will lower drug prices.

References

1. Replimune announces Type A meeting scheduled with FDA. News release. Replimune. September 2, 2025. Accessed September 2, 2025. https://tinyurl.com/y95a24u6
2. Replimune receives complete response letter from FDA for RP1 biologics license application for the treatment of advanced melanoma. News release. Replimune. July 22, 2025. Accessed September 2, 2025. https://tinyurl.com/2335n7sk
3. Clearance of investigational new drug application for AVZO-103, a potential best-in-class Nectin4/TROP2 bispecific antibody-drug conjugate. News release. September 2, 2025. Accessed September 2, 2025. https://tinyurl.com/hshausjk
4. OS Therapies provides OST-HER2 recurrent, fully resected, pulmonary metastatic osteosarcoma program update following FDA End of Phase 2 Meeting. News release. OS Therapies. September 2, 2025. Accessed September 2, 2025. https://tinyurl.com/43ss7kad
5. Sneha SK, Singh P. AI-driven drug discovery picks up as FDA pushes to reduce animal testing. News release. Reuters. September 2, 2025. Accessed September 2, 2025. https://tinyurl.com/433fcv3d