Genitourinary Cancer

FDA Updates Darolutamide Label for Prostate Cancer

January 11, 2021

The FDA has approved a supplemental new drug application to add overall survival (OS) and other secondary end point data from the phase 3 ARAMIS trial (NCT02200614) to the prescribing information for darolutamide (Nubeqa) for the treatment of patients with nonmetastatic prostate cancer (nmCRPC).

FDA Approves PSMA-Targeted Imaging Drug for Prostate Cancer

December 01, 2020

The FDA approved Gallium 68 PSMA-11 (Ga 68 PSMA-11), a drug for PET imaging of prostate-specific membrane antigen (PSMA) positive levels in men with suspected prostate cancer metastasis, who may be curable by surgery or radiation therapy.

FDA Approves Companion Diagnostic, FoundationOne Liquid CDx, for Olaparib in Prostate Cancer

November 09, 2020

The FDA has approved the FoundationOne Liquid CDx for use as a companion diagnostic with olaparib (Lynparza), which is indicated for select patients with deleterious or suspected deleterious germline or somatic homologous recombination repair (HRR) gene–mutated metastatic castration-resistant prostate cancer (mCRPC).

Nivolumab Plus Cabozantinib Gets Priority Review for Advanced RCC Treatment

October 20, 2020

The FDA has granted a priority review designation to a supplemental biologics license application and supplemental new drug application for nivolumab (Opdivo) plus cabozantinib (Cabometyx) for the treatment of patients with advanced renal cell carcinoma.

FDA Approval Sought for TLX591-CDx for Prostate Cancer Imaging

September 28, 2020

A new drug application has been submitted to the FDA for TLX591-CDx, a radiopharmaceutical product that targets prostate-specific membrane antigen, for the imaging of prostate cancer through the use of positron emission tomography.

Molecularly-Guided Therapy Improves Outcomes in Kidney Cancer

September 22, 2020

Findings from the noncomparative, phase 2, biomarker-driven BIONIKK trial demonstrated clinical evidence to support the use of molecularly-directed frontline therapy as means to enrich responses in patients with metastatic clear cell renal cell carcinoma (ccRCC).