Bladder Cancer: Latest Developments

Short summaries of recently published approvals, licensing and reimbursement regulations in Turkey, and notable studies in bladder cancer. For general information about the disease, see the Bladder Cancer page.

• • FDA Approval
  • Bladder Cancer
  • 14 October 2026

  In BCG-unresponsive non-muscle invasive bladder cancer, the approval of nogapendekin alfa inbakicept was expanded to include patients with papillary-only tumors

  The FDA expanded the indication of nogapendekin alfa inbakicept, given into the bladder (intravesically) together with BCG. It was approved in April 2024 for BCG-unresponsive non-muscle invasive bladder cancer with carcinoma in situ (CIS); the new decision also covers patients with high-grade papillary-only tumors without CIS. The expansion is not based on a new trial but on extrapolation of earlier data: in the QUILT-3.032 trial, the complete response rate was 62% in 77 patients with CIS, and among complete responders the response lasted at least 12 months in 58% and at least 24 months in 40%. The FDA concluded that both tumor types carry a similar risk in these patients. Common side effects include painful urination, blood in the urine, frequent urination and urinary tract infection. The label warns that delaying cystectomy can lead to spread of the disease. Treatment decisions should be made jointly by the urologist and the medical oncologist.

  Status in Turkey: No product containing nogapendekin alfa inbakicept appears in the TİTCK list of licensed medicinal products dated 09.10.2026.

  • Source:
  • FDA announcement (14 October 2026)
  • FDA announcement (22 April 2024, initial approval)
• • FDA Approval
  • Bladder Cancer
  • 10 July 2026

  Enfortumab vedotin and pembrolizumab approved in muscle-invasive bladder cancer, including in cisplatin-eligible patients

  The FDA expanded the use of pembrolizumab with enfortumab vedotin before surgery (neoadjuvant) and after cystectomy (adjuvant) to cover all patients with muscle-invasive bladder cancer who are candidates for cystectomy. This regimen had been approved in November 2025 for patients who cannot receive cisplatin. In the KEYNOTE-B15/EV-304 trial, 808 cisplatin-eligible patients were randomised to this combination or to preoperative gemcitabine-cisplatin chemotherapy. The hazard ratio for event-free survival was 0.53 and for overall survival 0.65; median event-free survival was 48.5 months in the chemotherapy arm and had not yet been reached in the combination arm. The safety profile was similar to earlier trials of this combination in urothelial cancer. The treatment decision should be made jointly by a urologist and a medical oncologist.

  Status in Turkey: Enfortumab vedotin is licensed in Turkey but is not on the SGK EK-4/A list; the licence and reimbursement status of this use in Turkey has not yet been clarified.

  • Source:
  • FDA announcement (10 July 2026)
• • FDA Approval
  • Bladder Cancer
  • 28 May 2026

  Durvalumab receives FDA approval together with BCG in high-risk non-muscle-invasive bladder cancer

  The FDA approved durvalumab together with BCG induction and maintenance therapy in adults with high-risk non-muscle-invasive bladder cancer who have not previously received BCG. High risk is defined by features such as a T1 tumour, a high-grade tumour, carcinoma in situ, or multiple, recurrent and large tumours. The POTOMAC trial enrolled 1018 patients after transurethral resection, who were randomised into three arms. Compared with BCG alone, durvalumab plus BCG gave a hazard ratio of 0.68 for disease-free survival; median values were not reached in either arm. Durvalumab is given every four weeks for up to 13 cycles. Warnings include immune-mediated adverse reactions.

  Status in Turkey: Durvalumab is licensed in Turkey for other indications; the licence and reimbursement status of this bladder cancer use in Turkey has not yet been clarified.

  • Source:
  • FDA announcement (28 May 2026)
• • FDA Approval
  • Bladder Cancer
  • 15 May 2026

  Atezolizumab receives FDA approval in bladder cancer for patients with tumour DNA detected in the blood after surgery

  The FDA approved atezolizumab as adjuvant treatment in adults with muscle-invasive bladder cancer in whom molecular residual disease was detected by circulating tumour DNA (ctDNA) in the blood after radical cystectomy; a blood test measuring ctDNA was also approved as a companion diagnostic. In the IMvigor011 trial, 250 patients with ctDNA positivity detected by serial blood tests within 12 months after surgery were randomised to atezolizumab or placebo. Median disease-free survival was 9.9 versus 4.8 months (hazard ratio 0.64) and median overall survival 32.8 versus 21.1 months (hazard ratio 0.59). Treatment is given every four weeks for up to one year. Warnings include immune-mediated adverse reactions.

  Status in Turkey: Atezolizumab is licensed in Turkey for other indications; the licence and reimbursement status of this ctDNA-based adjuvant use in Turkey has not yet been clarified.

  • Source:
  • FDA announcement (15 May 2026)

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The news on this page is for general information only; it is not a diagnosis or treatment recommendation. Whether a treatment is suitable for you is decided together with your physician after assessing the characteristics of your disease.