On September 24, 2026, the FDA approved belzutifan with lenvatinib for adults with advanced clear-cell renal cell carcinoma after a PD-1 or PD-L1 inhibitor; versus cabozantinib, median progression-free survival was 14.6 versus 10.6 months (HR 0.74), while the final overall survival comparison was not statistically significant (HR 0.85).
U.S. FDA
On July 31, 2026, the FDA approved lutetium Lu 177 vipivotide tetraxetan with an androgen-receptor pathway inhibitor for PSMA-positive metastatic androgen-pathway-naive or -sensitive prostate cancer, with patients selected using Locametz or another approved PSMA PET product; in PSMAddition (1,144 patients) radiographic progression-free survival HR was 0.72 and median radiographic progression-free survival was not reached in either arm.
U.S. FDA
On July 10, 2026, the FDA extended perioperative pembrolizumab, or pembrolizumab and berahyaluronidase alfa-pmph, with enfortumab vedotin to adults with muscle-invasive bladder cancer who are candidates for cystectomy, including those eligible for cisplatin; in KEYNOTE-B15/EV-304 (808 patients) event-free survival HR was 0.53 and overall survival HR was 0.65 versus neoadjuvant gemcitabine and cisplatin.
U.S. FDA
ClinicalTrials.gov lists the observational TiMBER study (NCT07726602), led by OHSU, as recruiting from a June 29, 2026 start date to test whether Labcorp Plasma Detect ctDNA corresponds with recurrence after curative-intent treatment for muscle-invasive urothelial carcinoma.
ClinicalTrials.gov
On June 12, 2026, the FDA approved belzutifan with pembrolizumab, or with pembrolizumab and berahyaluronidase alfa-pmph, as adjuvant treatment for adults with clear-cell renal cell carcinoma at intermediate-high or high risk of recurrence after nephrectomy, or after nephrectomy and resection of metastases; in LITESPARK-022 (1,841 patients) disease-free survival HR was 0.72 and median disease-free survival was not reached in either arm.
U.S. FDA
On June 12, 2026, the FDA approved capivasertib with abiraterone and prednisone for PTEN-deficient metastatic androgen-pathway-naive or -sensitive prostate cancer, and approved the VENTANA PTEN (SP218) RxDx Assay, which calls PTEN deficiency when at least 90% of viable malignant cells have no specific cytoplasmic staining; in CAPItello-281 (1,012 patients) median radiographic progression-free survival was 33.2 versus 25.7 months (HR 0.81), and overall survival was immature.
U.S. FDA
In the phase 3 ALTAIR trial published in Nature Medicine on June 8, 2026, 243 patients with resected colorectal cancer who became tumor-informed ctDNA-positive without radiographic disease were randomized to trifluridine/tipiracil or placebo; median disease-free survival was 9.30 versus 5.55 months (HR 0.79; P = 0.107), so the primary endpoint was not met.
Nature Medicine
ClinicalTrials.gov lists NCT07401316, a diagnostic study led by Indiana University with Natera, as recruiting from a June 3, 2026 start date to measure the positive predictive value of ctDNA in high-risk stage I, stage II, and stage III germ cell tumors.
ClinicalTrials.gov
On May 28, 2026, the FDA approved durvalumab with BCG for adults with BCG-naive high-risk non-muscle-invasive bladder cancer, based on POTOMAC (1,018 patients), where durvalumab plus BCG induction and maintenance improved investigator-assessed disease-free survival versus BCG alone (HR 0.68; median not reached in either arm).
U.S. FDA
The FDA companion-diagnostic list dated May 27, 2026 includes FoundationOne CDx (P170019/S060) and FoundationOne Liquid CDx (P190032/S029) to identify homologous-recombination-repair gene alterations for talazoparib plus enzalutamide in metastatic castration-resistant prostate cancer.
U.S. FDA
At the NCCN 2026 Annual Conference, enfortumab vedotin plus pembrolizumab was described as the sole preferred first-line regimen in the bladder cancer guideline for locally advanced or metastatic disease.
The ASCO Post
At the NCCN 2026 Annual Conference, faculty reported that ADT plus niraparib and abiraterone is listed for BRCA2-mutated metastatic androgen-pathway-sensitive prostate cancer, as useful in certain circumstances for high-volume disease and as a category 2B option for low-volume disease.
The ASCO Post
Faculty at the NCCN 2026 Annual Conference described perioperative durvalumab with gemcitabine and cisplatin as the preferred treatment for cisplatin-eligible muscle-invasive bladder cancer.
The ASCO Post
The 2026 NCCN kidney cancer discussion added a recommendation, for non-clear-cell renal cell carcinoma, to consider tumor genomic testing for clinical-trial eligibility.
The ASCO Post
The NCCN 2026 prostate cancer update presented at the NCCN Annual Conference adds a table of FDA-cleared PET imaging tracer studies, in a discussion that noted prior registration trials used conventional imaging rather than PSMA PET.
The ASCO Post
Faculty at the NCCN 2026 Annual Conference described a new prostate-guideline pathway for metastasis-directed therapy in metachronous oligometastatic androgen-pathway-sensitive disease, including metachronous low-volume M1 disease.
The ASCO Post
Faculty at the NCCN 2026 Annual Conference said subsequent therapy for renal cell carcinoma now includes lenvatinib as a category 2A option in defined settings, while axitinib plus pembrolizumab, cabozantinib plus nivolumab, and lenvatinib plus pembrolizumab moved from category 2A to 2B, and axitinib plus avelumab was removed.
The ASCO Post
At the NCCN 2026 Annual Conference, faculty reported that ipilimumab plus nivolumab moved from category 2A to a category 1 preferred first-line regimen for clear-cell renal cell carcinoma.
The ASCO Post