Kidney Cancer: Latest Developments

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

• • FDA Approval
  • Kidney Cancer
  • 24 September 2026

  The combination of belzutifan and lenvatinib received FDA approval for kidney cancer that progressed after immunotherapy

  The FDA approved the HIF-2α inhibitor belzutifan together with lenvatinib for use in advanced renal cell carcinoma with a clear cell component that has progressed after a PD-1 or PD-L1 inhibitor. In the LITESPARK-011 trial, 747 patients were randomised to this combination or to cabozantinib. Median progression-free survival was 14.6 versus 10.6 months (hazard ratio 0.74) and the objective response rate 53% versus 40%. In the final analysis of overall survival, however, no statistically significant difference could be shown (33.7 versus 28.6 months; hazard ratio 0.85). Belzutifan carries a boxed warning on harm to the fetus in pregnancy; anaemia and low oxygen levels (hypoxia) are among the adverse effects to be monitored.

  Status in Turkey: The TİTCK list of licensed products dated 02.10.2026 contains no product with belzutifan.

  • Source:
  • FDA announcement (24 September 2026)
• • FDA Approval
  • Kidney Cancer
  • 12 June 2026

  Belzutifan and pembrolizumab combination receives FDA approval after surgery in kidney cancer

  The FDA approved the combination of belzutifan and pembrolizumab as adjuvant (postoperative protective) treatment in renal cell carcinoma with a clear cell component in patients at intermediate-high or high risk of recurrence after nephrectomy, or whose metastases have been removed surgically. In the LITESPARK-022 trial, 1841 patients were randomised to belzutifan or placebo in addition to pembrolizumab. At the interim analysis, the hazard ratio for disease-free survival was 0.72 (186 events in the belzutifan arm and 246 in the placebo arm); median values were not reached in either arm. Overall survival data are not yet mature. Pembrolizumab is given for up to 12 months and belzutifan for up to 54 weeks. The warning on fetal harm in pregnancy and adverse effects such as anaemia and hypoxia should be monitored.

  Status in Turkey: The TİTCK list of licensed products dated 02.10.2026 contains no product with belzutifan.

  • Source:
  • FDA announcement (12 June 2026)
• • SGK Reimbursement
  • Kidney Cancer
  • 17 January 2026

  SGK removed the age limit of 65 for the combination of nivolumab and ipilimumab in advanced kidney cancer

  With the SUT amendment published in the Official Gazette of 17 January 2026 (no. 33140), the phrase “aged 65 or under” was removed from the reimbursement conditions of the nivolumab and ipilimumab combination in advanced-stage renal cell carcinoma. As a result, there is no longer an upper age limit for first-line use of this combination in previously untreated patients who are at intermediate or poor risk by the IMDC risk classification and have an adequate general condition (Karnofsky performance score of 70 or above). Ipilimumab is given for a maximum of four doses. The regulation entered into force 5 working days after publication. In older patients, the decision on immunotherapy is made by considering comorbidities, general condition and the risk of side effects together.

  Status in Turkey: Products containing nivolumab and ipilimumab are on the SGK EK-4/A list; use is based on a health board report that includes a medical oncology specialist.

  • Source:
  • Official Gazette, 17.01.2026, no. 33140 (SUT amendment)
  • Official Gazette, 10.07.2025, no. 32952 (relevant SUT text)

There are no developments to show for this selection. You can change the filters and try again.

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.