Stay Up
to Date
Stay Up
to Date
Breaking News,
Updates, & More
Breaking News,
Updates, & More
Click Here to
Subscribe
Click Here to
Subscribe

Nubeqa New Oral Therapy FDA Approved for Nonmetastatic Prostate Cancer

Web Exclusives - FDA Updates

On July 30, 2019, the FDA approved darolutamide (Nubeqa; Bayer HealthCare), an oral androgen receptor inhibitor, for the treatment of patients with nonmetastatic castration-resistant prostate cancer (CRPC). This approval was based on a multicenter, double-blind, placebo-controlled clinical trial known as ARAMIS. The FDA granted this application priority review.

“Patients at this stage of prostate cancer typically don’t have symptoms of the disease. The overarching goals of treatment in this setting are to delay the spread of prostate cancer and limit the burdensome side effects of therapy,” Matthew Smith, MD, PhD, Director, Genitourinary Malignancies Program, Massachusetts General Hospital Cancer Center, said in a statement.

The study included 1509 patients with nonmetastatic CRPC who were randomized in a 2:1 ratio to darolu­tamide or to placebo. In addition, all patients received a gonadotropin-releasing hormone analog unless they previously had a bilateral orchiectomy.

The primary end point was metastasis-free survival. The median metastasis-free survival was 40.4 months (95% confidence interval [CI], 34.3 months-not reached) with darolutamide versus 18.4 months (95% CI, 15.5-22.3 months) with placebo (hazard ratio, 0.41; 95% CI, 0.34-0.50; P <.0001). The overall survival data were not yet mature at the FDA approval.

The most common (≥2%) adverse events with darolutamide were fatigue, extremity pain, and rash. Ischemic heart disease (4.3%) and heart failure (2.1%) were more common with darolutamide than with placebo.

Related Items
FDA Grants Priority Review to Keytruda for Patients with High-Risk, Non–Muscle-Invasive Bladder Cancer
Web Exclusives published on December 3, 2019 in Bladder Cancer, FDA Updates, Immunotherapy
Inrebic Receives FDA Approval for Adults with Myelofibrosis
Web Exclusives published on December 2, 2019 in FDA Updates
FDA Approved Erleada for Metastatic Castration-Sensitive Prostate Cancer
Web Exclusives published on December 2, 2019 in FDA Updates
Keytruda plus Lenvima Combo FDA Approved for Advanced Endometrial Carcinoma with No MSI-H or dMMR Tumors
Web Exclusives published on December 2, 2019 in FDA Updates
FDA Approves Adakveo to Reduce Vaso-Occlusive Crises in Patients with Sickle-Cell Disease
Web Exclusives published on November 25, 2019 in FDA Updates, In the News
November 25, 2019 – Oncology News & Updates
Web Exclusives published on November 25, 2019 in FDA Updates, In the News, Leukemia, Lung Cancer, Lymphoma
November 18, 2019 — Oncology News & Updates
Web Exclusives published on November 18, 2019 in Drug Updates, FDA Updates, Hepatocellular Carcinoma, In the News, Lymphoma
November 11, 2019 — Oncology News & Updates
Web Exclusives published on November 11, 2019 in FDA Updates, In the News
Turalio First FDA-Approved Systemic Therapy for Tenosynovial Giant-Cell Tumor
Web Exclusives published on October 29, 2019 in FDA Updates
Rozlytrek Third FDA-Approved Tumor-Agnostic Drug and Second Treatment for Patients with NTRK Fusion Tumors
Web Exclusives published on October 29, 2019 in FDA Updates
Last modified: October 29, 2019