U.S. Food and Drug Administration approvals, labels, and draft guidance.
On May 15, 2026, the FDA approved atezolizumab and atezolizumab/hyaluronidase as adjuvant treatment for adults with muscle-invasive bladder cancer after cystectomy who have ctDNA molecular residual disease on an FDA-authorized test, and approved Signatera CDx to select those patients; in IMvigor011 median disease-free survival was 9.9 versus 4.8 months (HR 0.64) and median overall survival was 32.8 versus 21.1 months (HR 0.59).
U.S. FDA
On January 21, 2026, the FDA released draft guidance on using minimal residual disease and complete response in multiple myeloma to support accelerated approval, defining the MRD endpoint as bone-marrow negativity by flow cytometry or sequencing in patients who have achieved complete response or stringent complete response, and noting that the April 12, 2024 ODAC unanimously accepted MRD as an accelerated-approval endpoint.
Federal Register
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 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
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
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
On May 11, 2026, the FDA approved the Atellica IM free PSA II assay to measure free PSA with a total PSA assay in men 50 years and older whose total PSA is 4 to 10 ng/mL and whose digital rectal exam is not suspicious for cancer, as an aid in distinguishing prostate cancer from benign prostatic disease.
U.S. FDA
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 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
On November 21, 2025, the FDA approved pembrolizumab, or pembrolizumab and berahyaluronidase alfa-pmph, with enfortumab vedotin as neoadjuvant treatment and adjuvant treatment after cystectomy for adults with muscle-invasive bladder cancer who are ineligible for cisplatin; in KEYNOTE-905/EV-303 (344 patients) event-free survival HR was 0.40 and overall survival HR was 0.50 versus surgery alone.
U.S. FDA