FDA Oncology News: June 2025 Updates

The U.S. Food and Drug Administration (FDA) is a federal agency within the Department of Health and Human Services responsible for protecting public health by ensuring the safety, efficacy, and security of human and veterinary drugs, vaccines, biological products, and medical devices. Within the realm of oncology, the FDA’s Oncology Center of Excellence (OCE) leads cancer product evaluations and coordinates global regulatory strategies through initiatives like Project Orbis, enabling faster access to innovative therapies for patients worldwide.

Oncology Approvals in June 2025

The FDA made six significant oncology approvals in June 2025, impacting head and neck, bladder, lung, and prostate cancers. These decisions were based on robust clinical trial data and represent shifts toward personalized medicine, curative-intent immunotherapy, and novel local delivery systems.

Pembrolizumab (Keytruda) Approved as Neoadjuvant and Adjuvant Therapy in Head and Neck Cancer

On June 12, 2025, the FDA approved pembrolizumab (Keytruda) for both neoadjuvant (pre-surgery) and adjuvant (post-surgery) use, in combination with radiotherapy—with or without cisplatin—for adults with resectable, locally advanced head and neck squamous cell carcinoma (HNSCC) whose tumors express PD‑L1 with a Combined Positive Score (CPS) ≥ 1.

This marks the first approval of a checkpoint inhibitor for curative-intent use in this setting and is based on strong evidence demonstrating improved outcomes, including enhanced event-free survival, over the current standard of care.

Zusduri (Mitomycin Intravesical Solution) for Bladder Cancer

On June 12, 2025, the FDA approved Zusduri, an intravesical mitomycin solution, for adults with recurrent, low-grade, intermediate-risk non–muscle invasive bladder cancer (LG‑IR‑NMIBC) .

In a pivotal late-stage single-arm trial involving 223 patients, a 78% complete response rate was observed, significantly reducing tumor recurrence. This gel-based therapy adheres longer to the bladder lining, offering an effective, office-based alternative to repeated surgery.

Taletrectinib (Ibtrozi) for ROS1‑Positive NSCLC

On June 11, 2025, the FDA approved Taletrectinib (Ibtrozi), a kinase inhibitor, for adults with locally advanced or metastatic ROS1-positive non‑small cell lung cancer (NSCLC).

The approval followed a comprehensive FDA review of data—including a pooled analysis from Phase II trials—demonstrating robust efficacy in treatment-naïve and TKI-resistant patients, marking it as the 15th novel drug approval of 2025.

Darolutamide (Nubeqa) for Metastatic Castration-Sensitive Prostate Cancer

One June 3, 2025,  the FDA approved an expanded indication for Darolutamide (Nubeqa) for the treatment of metastatic castration-sensitive prostate cancer (mCSPC) in combination with androgen deprivation therapy (ADT), with or without docetaxel.

This approval is supported by the Phase III ARASENS trial (NCT02799602), which showed that the addition of darolutamide to ADT and docetaxel significantly improved overall survival, reducing the risk of death by 32.5% compared to ADT and docetaxel alone. The combination also delayed disease progression with a favorable safety profile.

Tafasitamab-cxix (Monjuvi) for Relapsed or Refractory Follicular Lymphoma

On June 18, 2025, the FDA approved tafasitamab-cxix (Monjuvi) in combination with lenalidomide and rituximab for the treatment of adults with relapsed or refractory follicular lymphoma (FL) who have received at least two prior systemic therapies.

This approval was based on clinical data demonstrating durable responses in a population with limited treatment options. Tafasitamab is a CD19-directed cytolytic antibody, and its combination with immunomodulatory agents offers a novel mechanism of action in indolent B-cell lymphoma.

Datopotamab Deruxtecan-dlnk (Datroway) for EGFR-Mutated Non-Small Cell Lung Cancer

On June 23, 2025, the FDA granted accelerated approval to datopotamab deruxtecan-dlnk (Datroway) for the treatment of adults with locally advanced or metastatic EGFR-mutated non-small cell lung cancer (NSCLC) who have previously received an EGFR-targeted therapy and platinum-based chemotherapy.

This approval is supported by results from a Phase I/II trial, which demonstrated an overall response rate of approximately 45%, with a median duration of response of 6.5 months. Datroway is an antibody-drug conjugate (ADC) targeting TROP2, offering a new therapeutic option for patients with limited alternatives after progression on standard treatments.

Key Takeaways from June 2025 Oncology FDA Approvals

• Earlier Use of Immunotherapy
  Pembrolizumab’s approval in HNSCC demonstrates FDA’s move toward curative-intent regimens using checkpoint inhibitors earlier in treatment courses.
• Precision Medicine on the Rise
  Taletrectinib reinforces the growing reliance on genomic biomarkers (e.g., ROS1) to guide NSCLC treatment decisions, especially in hard-to-treat subtypes with brain involvement.
• Local Drug Delivery Innovations
  Zusduri introduces a modern solution for bladder cancer that avoids surgery and maximizes intravesical drug retention.
• Expanded Systemic Options in Prostate Cancer
  Darolutamide’s approval for mCSPC broadens frontline therapy for metastatic disease with a tolerable safety profile.
• Regulatory Efficiency
  All approvals reflect FDA’s increasing emphasis on rapid, data-driven approvals, especially through mechanisms like the Oncology Center of Excellence, Breakthrough Therapy Designation, and priority reviews.

Written by Nare Hovhannisyan, MD