Astellas and Pfizer Bladder Cancer Therapy Recommended by UK’s NICE

The United Kingdom’s National Institute for Health and Care Excellence (NICE) has issued final guidance recommending the reimbursement of Astellas Pharma and Pfizer’s antibody-drug conjugate enfortumab vedotin (Padcev) with Merck (known as MSD outside of the United States and Canada)’s pembrolizumab (Keytruda) for first-line treatment of adult patients with unresectable or metastatic urothelial cancer who are eligible for chemotherapy containing platinum (1).

Trial results show promise

According to a press release from Astellas, the designation stands to substantially increase overall survival rates for patients with bladder cancer in England and Wales.

“The guidance from NICE is excellent news for patients,” Timir Patel, MD, medical director, Astellas UK, said in the release (1). “Advanced bladder cancer is in an area where there is a real unmet need. This combination therapy changes the standard of care for doctors and their patients.”

NICE’s decision was based on results of a Phase III trial (EV-302), for which researchers observed a median overall survival of 33.8 months with enfortumab vedotin plus pembrolizumab versus 15.9 with platinum-based chemotherapy, with respective median progression-free survival times of 12.5 and 6.3 months, representing a 55% reduction in the risk of cancer progression or death in the combination arm (1).

"Prior to the EV-302 clinical trial, the treatment of advanced bladder cancer treatment hadn’t significantly changed since the 1980s,” Thomas Powles, professor and director of Barts Cancer Institute Biomedical Research Centre, and primary investigator on the EV-302 trial, said in the Astellas press release (1). “This guidance will fundamentally reshape first-line treatment for eligible patients."

Treatments developing for bladder cancer

Bladder cancer represents 3% of all cancer deaths in the UK, according to Astellas, with 5600 deaths attributed to the disease annually (1). The company said that only 29% of patients with stage IV bladder cancer survive more than a year after diagnosis.

In April 2024, SK pharmteco entered an agreement with Ferring Pharmaceuticals to provide scale-up manufacturing capacity for the company’s gene therapy, Adstiladrin (nadofaragene firadenovec-vncg), to ensure long-term supply of the bladder cancer treatment (2).

The UK’s Medicines and Healthcare products Regulatory Agency granted marketing authorization in November 2024 to Johnson & Johnson’s erdafitinib (Balversa), as a monotherapy in treating adults with unresectable or metastatic urothelial carcinoma, specifically covering eligible patients harboring susceptible fibroblast growth factor receptor 3 genetic alterations (3).

NICE’s final guidance for enfortumab vedotin in combination with pembrolizumab followed approvals for the same indication in December 2023 by FDA and August 2024 by the European Commission (1).

Other Astellas activity

In February 2025, Astellas Pharma announced that FDA updated the labeling for avacincaptad pegol intravitreal solution (Izervay) by approving the drug to treat geographic atrophy (GA) secondary to age-related macular degeneration without a limitation on duration of dosing, which offers greater flexibility for managing GA by allowing longer-term treatment (4). This followed the company’s December 2024 resubmission of a supplemental new drug application for avacincaptad pegol intravitreal solution.

More recently, Brandon Carr, head of downstream process development, gene therapy research operations with Astellas, discussed the unique challenges of downstream processing of adeno-associated viral vectors in the July/August 2025 issue of BioPharm International® (5). Click here to read that article in full.

The partnership between Astellas and Pfizer additionally includes an androgen receptor inhibitor-based regimen, enzalutamide (Xtandi), which demonstrated overall survival benefit in non-metastatic hormone-sensitive prostate cancer with high-risk biochemical recurrence in a Phase III study in July 2025 (6).

Finally, Astellas Pharma is slated to be one of the participating organizations at the 15th annual Partnership Opportunities in Drug Delivery conference, happening Oct. 27–28, 2025 in Boston (7).

References

1. Astellas. NICE Guidance Ushers in New Era for Metastatic Bladder Cancer Therapy. Press Release. Aug. 21, 2025.
2. Haigney, S. SK pharmteco and Cryoport Collaborate on Cell and Gene Therapies. BioPharmInternational.com, Sept. 26, 2024.
3. Johnson & Johnson. MHRA Grants Marketing Authorization for Balversa (erdafitinib) as Monotherapy for the Treatment of Adults with Unresectable or Metastatic Urothelial Carcinoma Harbouring Susceptible FGFR3 Genetic Alterations Who Have Previously Received At Least One LinePress Release. Nov. 6, 2024.
4. Astellas Pharma. US FDA Approves Expanded Label for Astellas’ Izervay (avacincaptad pegol intravitreal solution) for Geographic Atrophy. Press Release. Feb. 13, 2025.
5. Challener, C. A. Time-to-Market Pressures Are Influencing Downstream Processing Innovations. BioPharm International 2025, 38 (6) 8–11.
6. Haigney, S. Pfizer Obtains Exclusive Rights to 3SBio’s Bispecific Antibody Targeting PD-1 and VEGF. BioPharmInternational.com, July 25, 2025.
7. Cole, C. PODD 2025 Unveils Agenda Highlighting Innovation in Drug Delivery Technologies. PharmTech.com, July 16, 2025.