The first half of 2026 has brought several important FDA approvals in GU Cancers, spanning prostate cancer, renal cell carcinoma, and bladder cancer. These decisions reflect a continued move toward biomarker-driven treatment, perioperative/adjuvant strategies, and new combinations designed to reduce recurrence risk after local therapy.
For clinicians, researchers, and patients, these approvals introduce new options but also new questions around patient selection, molecular testing, sequencing, and safety monitoring. Below, we review four major FDA drug approvals in GU oncology during this period.
Atezolizumab for ctDNA MRD-Positive MIBC
On May 15, 2026, the FDA approved atezolizumab and atezolizumab and hyaluronidase-tqjs as adjuvant treatments for adults with muscle-invasive bladder cancer after cystectomy who have circulating tumor DNA molecular residual disease, as determined by an FDA-authorized test.
The approval was based on IMvigor011, a multicenter, randomized, double-blind, placebo-controlled trial enrolling 250 patients with MIBC who had undergone radical cystectomy with lymph node dissection and had MRD detected by serial ctDNA testing during the following 12 months, starting at least 6 weeks after cystectomy.
Patients were randomized to receive atezolizumab or placebo every four weeks for up to 12 cycles or one year, unless there was disease recurrence or unacceptable toxicity.
Atezolizumab improved median disease-free survival to 9.9 months compared with 4.8 months for placebo (HR 0.64; p = 0.0047). Median overall survival was also longer with atezolizumab, at 32.8 months versus 21.1 months with placebo (HR 0.59; p = 0.0131).
The prescribing information includes warnings for immune-mediated adverse reactions, infusion-related reactions, complications of allogeneic hematopoietic stem cell transplantation, and embryo-fetal toxicity. This approval marks an important step for ctDNA-guided adjuvant therapy in bladder cancer, using molecular residual disease to identify patients who may benefit from treatment after cystectomy.
Signatera CDx as Companion Diagnostic for ctDNA-Guided Adjuvant Atezolizumab in MIBC
Alongside the atezolizumab approval, the FDA approved Signatera CDx as a companion diagnostic to identify patients with muscle-invasive bladder cancer after cystectomy who have ctDNA molecular residual disease. The test is used to select patients eligible for adjuvant treatment with atezolizumab or atezolizumab and hyaluronidase-tqjs. Patients with negative Signatera CDx results should continue serial testing until a positive result or completion of the recommended 12-month testing window.
This approval highlights the growing role of ctDNA MRD testing in bladder cancer, moving adjuvant treatment decisions beyond clinicopathologic risk alone.
Durvalumab with BCG for BCG-Naïve High-Risk NMIBC
On May 28, 2026, the FDA approved durvalumab in combination with Bacillus Calmette-Guerin for adults with BCG-naïve, high-risk non-muscle invasive bladder cancer.
The approval was supported by the POTOMAC study, a randomized, open-label, multicenter trial that enrolled 1,018 patients with high-risk NMIBC after transurethral resection of bladder tumor. High-risk disease included T1 tumor, grade 3 or high-grade tumor, carcinoma in situ, or multiple, recurrent, and large tumors.
Patients received durvalumab every four weeks for 13 cycles plus BCG induction and maintenance, BCG induction and maintenance alone, or another investigational combination regimen. Durvalumab plus BCG significantly improved disease-free survival compared with BCG alone (HR 0.68; p = 0.0154). Median DFS was not reached in either arm.
The prescribing information includes warnings for immune-mediated adverse reactions, infusion-related reactions, complications of allogeneic hematopoietic stem cell transplantation, and embryo-fetal toxicity.
This approval introduces immune checkpoint inhibition alongside BCG in BCG-naïve, high-risk NMIBC, adding a new option for patients treated after tumor resection.
Capivasertib with Abiraterone and Prednisone for PTEN-Deficient Prostate Cancer
On June 12, 2026, the FDA approved capivasertib in combination with abiraterone and prednisone for adults with metastatic androgen pathway modulation-naïve or -sensitive prostate cancer, previously referred to as metastatic hormone-sensitive prostate cancer, that is PTEN-deficient by an FDA-authorized test. The FDA also approved the VENTANA PTEN (SP218) RxDx Assay as a companion diagnostic.
The approval was based on CAPItello-281, a randomized, double-blind, placebo-controlled, multicenter trial that enrolled 1,012 adults with newly diagnosed PTEN-deficient mAPMN/S prostate cancer.
Patients were randomized to receive capivasertib with abiraterone or placebo with abiraterone. Abiraterone was administered with prednisone or prednisolone.
Median radiographic progression-free survival was 33.2 months with capivasertib plus abiraterone versus 25.7 months with placebo plus abiraterone (HR 0.81; p = 0.034). Overall survival data were immature at the time of the analysis.
The prescribing information includes warnings for hyperglycemia, diarrhea, cutaneous adverse reactions, and embryo-fetal toxicity. This approval adds a biomarker-selected targeted treatment approach for patients with PTEN-deficient metastatic prostate cancer in the androgen pathway modulation-naïve or -sensitive setting.
Belzutifan with Pembrolizumab for Adjuvant Renal Cell Carcinoma
On June 12, 2026, the FDA approved belzutifan in combination with pembrolizumab, or pembrolizumab and berahyaluronidase alfa-pmph, for the adjuvant treatment of adults with renal cell carcinoma with a clear cell component who are at intermediate-high or high risk of recurrence after nephrectomy, or after nephrectomy and resection of metastatic lesions.
The approval was based on LITESPARK-022, a multicenter, double-blind, randomized trial enrolling 1,841 patients with prior nephrectomy for clear cell RCC who were at increased risk of recurrence or had resected metastases with no evidence of disease.
Patients received belzutifan plus pembrolizumab or placebo plus pembrolizumab as adjuvant therapy. Treatment continued until disease recurrence or unacceptable toxicity, or for up to 54 weeks of belzutifan and 12 months of pembrolizumab.
Belzutifan plus pembrolizumab significantly improved disease-free survival compared with placebo plus pembrolizumab (HR 0.72; p = 0.0003). Median DFS was not reached in either arm, and overall survival data were not mature.
Belzutifan includes a boxed warning for embryo-fetal toxicity and warnings for anemia and hypoxia. Pembrolizumab includes warnings for immune-mediated adverse reactions, infusion-related reactions, complications of allogeneic hematopoietic stem cell transplantation, and embryo-fetal toxicity.
This approval expands adjuvant treatment in clear cell RCC by adding belzutifan to pembrolizumab for patients at intermediate-high or high risk of recurrence after nephrectomy, or after nephrectomy and resection of metastatic lesions.
Full approval details are available on the official FDA website.