FDA updates in urology: June 2026

Welcome to Urology Times’® monthly FDA update! June 2026 brought a wave of regulatory developments across the urology landscape, spanning infectious disease, genitourinary oncology, men's health, imaging, and prosthetic devices. The month's actions included FDA approvals of a new treatment option for complicated urinary tract infections (cUTIs), renal cell carcinoma, and PTEN-deficient metastatic prostate cancer, as well as expanded access to prostate cancer imaging through a generic PSMA-PET radiodiagnostic. Additional highlights included approval of a next-generation inflatable penile prosthesis, tentative approval of generic enzalutamide, and requested testosterone therapy labeling updates that could reshape prescribing considerations for men with age-related hypogonadism.

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FDA news in urology from June 2026

1. FDA approves Titan Prime Inflatable Penile Prosthesis

On June 3, 2026, the FDA approved Titan Prime, an inflatable penile prosthesis (IPP) for patients with erectile dysfunction.¹ Titan Prime builds off the company’s initial Titan IPP by providing improved flaccid flexibility for comfort and concealability.

2. FDA approves generic Ga-68 PSMA-11 radiodiagnostic for prostate cancer

On June 10, the FDA approved an abbreviated new drug application (ANDA) for gallium Ga 68 gozetotide injection (Ga-68 PSMA-11), a radioactive diagnostic agent for PET imaging of prostate-specific membrane antigen-positive lesions in patients with prostate cancer.² Ga-68 PSMA-11, which was initially approved in December 2020, is indicated for imaging of patients with suspected prostate cancer metastases who are candidates for definitive therapy and imaging of patients with suspected recurrent disease based on elevated serum prostate-specific antigen levels.

3. FDA approves adjuvant belzutifan with pembrolizumab for ccRCC

On June 12, the FDA approved belzutifan (Welireg) in combination with pembrolizumab (Keytruda) or pembrolizumab and berahyaluronidase alfa-pmph (Keytruda Qlex) as adjuvant treatment for adult patients with renal cell carcinoma with a clear cell component at intermediate-high or high risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions.³ The approval was supported by data from the phase 3 LITESPARK-022 study (NCT05239728), which met its primary end point by showing that the addition of belzutifan to adjuvant pembrolizumab significantly improved disease-free survival vs pembrolizumab alone (HR, 0.72; 95% CI, 0.59 to 0.87; P = .0003).

4. FDA approves capivasertib plus abiraterone and prednisone for PTEN-deficient mHSPC

On June 12, 2026, the FDA approved capivasertib (Truqap) in combination with abiraterone acetate (Zytiga) and prednisone for adult patients with PTEN-deficient metastatic androgen pathway modulation-naïve or sensitive prostate cancer (previously metastatic hormone-sensitive prostate cancer), as detected by an FDA-authorized test.⁴ The agency also concurrently approved the VENTANA PTEN (SP218) RxDx Assay as a companion diagnostic device to identify patients with PTEN-deficient prostate cancer who may be eligible for treatment with capivasertib.

The approval is supported by data from the phase 3 CAPItello-281 trial (NCT04493853), which met its primary end point by showing that the addition of capivasertib to abiraterone and prednisone significantly improved radiographic progression-free survival vs abiraterone and prednisone alone (HR, 0.81; 95% CI, 0.66 to 0.98; P = .034).

5. FDA approves tebipenem pivoxil for complicated urinary tract infections

On June 17, 2026, the FDA approved tebipenem pivoxil (Utebzi), for cUTI, including pyelonephritis, caused by several susceptible microorganisms in adult patients who have limited or no alternative oral treatment options.⁵ The approval is backed by results from the phase 3 PIVOT-PO trial (NCT06059846), which demonstrated that tebipenem pivoxil was noninferior to imipenem-cilastatin in regard to the overall response rate (composite of clinical cure plus microbiological eradication) at the test-of-cure visit in hospitalized adult patients with cUTI.

6. HHS requests testosterone therapy label updates, citing new safety data

On June 19, the US Department of Health and Human Services, through the FDA, requested labeling updates for testosterone replacement therapy products, proposing removal of the longstanding limitation of use for age-related hypogonadism and revisions to prostate cancer and benign prostatic hyperplasia (BPH) warnings based on newer evidence.⁶ The proposed changes would limit the prostate cancer contraindication to men with metastatic disease, maintain recommendations for prostate screening and monitoring, and revise BPH warnings to reflect evidence showing no worsening of lower urinary tract symptoms in men with mild to moderate BPH receiving testosterone therapy.

7. FDA grants tentative approval to generic enzalutamide tablets

On June 26, the FDA granted tentative approval to an ANDA for generic enzalutamide tablets in 40-mg, 80-mg, 120-mg, and 160-mg strengths.⁷ The tentative approval includes bioequivalence for the 40-mg and 80-mg tablet strengths to the reference listed drug, Xtandi (enzalutamide; Astellas), while the company's proposed 120-mg and 160-mg formulations represent additional tablet strengths not currently available for the branded product.

REFERENCES

1. Coloplast’s next generation inflatable penile prosthesis approved by the FDA – can help millions of men. News release. Coloplast A/S. June 3, 2026. Accessed July 1, 2026. https://iu.coloplast.us/wp-content/uploads/2026/06/USIU_MH_Titan-Prime-IPP_FDA-approval-press-release_English.pdf

2. RadioMedix announces receiving FDA approval of its generic Ga-68 PSMA-11 radiodiagnostic for prostate cancer. News release. RadioMedix, Inc. June 10, 2026. Accessed July 1, 2026. https://www.globenewswire.com/news-release/2026/06/10/3309646/0/en/radiomedix-announces-receiving-fda-approval-of-its-generic-ga-68-psma-11-radiodiagnostic-for-prostate-cancer.html

3. FDA approves belzutifan with pembrolizumab for adjuvant treatment of renal cell carcinoma. News release. US Food & Drug Administration. June 12, 2026. Accessed July 1, 2026. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-belzutifan-pembrolizumab-adjuvant-treatment-renal-cell-carcinoma

4. FDA approves capivasertib with abiraterone and prednisone for PTEN-deficient androgen pathway modulation-naïve or -sensitive prostate cancer. News release. US Food & Drug Administration. June 12, 2026. Accessed July 1, 2026. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-capivasertib-abiraterone-and-prednisone-pten-deficient-androgen-pathway-modulation

5. FDA approves first oral carbapenem therapy for complicated urinary tract infections. News release. US Food & Drug Administration. June 17, 2026. Accessed July 1, 2026. https://www.fda.gov/drugs/news-events-human-drugs/fda-approves-first-oral-carbapenem-therapy-complicated-urinary-tract-infections

6. HHS announces requested updates to testosterone therapy product labels. News release. US Department of Health and Human Services. June 18, 2026. Accessed July 1, 2026. https://www.hhs.gov/press-room/fda-requests-updates-testosterone-therapy-labeling.html

7. Lupin receives tentative approval from U.S. FDA for enzalutamide tablets. News release. Lupin Limited. June 26, 2026. Accessed July 1, 2026. https://www.prnewswire.com/news-releases/lupin-receives-tentative-approval-from-us-fda-for-enzalutamide-tablets-302811905.html