FDA Approves Talzenna for Metastatic, Castration-Resistant Prostate Cancer
Medically reviewed by Drugs.com.
By Lori Solomon HealthDay Reporter
MONDAY, June 26, 2023 -- The U.S. Food and Drug Administration has approved Talzenna (talazoparib) with enzalutamide for homologous recombination repair (HRR) gene-mutated metastatic castration-resistant prostate cancer (mCRPC).
The approval was based on a trial in which 399 patients with HRR gene-mutated mCRPC were randomly assigned (1:1) to receive enzalutamide 160 mg daily plus either talazoparib 0.5 mg or placebo daily.
The results of the trial showed statistically significant improvement in radiographic progression-free survival (rPFS) for Talzenna with enzalutamide versus placebo. Median rPFS was not reached in the Talzenna group versus 13.8 months with placebo (hazard ratio, 0.45; 95 percent confidence interval, 0.33 to 0.61; P < 0.0001). For 155 patients with BRCA-mutated mCRPC, the hazard ratio for rPFS was 0.20 (95 percent confidence interval, 0.11 to 0.36), but for HRR gene-mutated mCRPC without BRCA mutations, the hazard ratio was 0.72 (95 percent confidence interval, 0.49 to 1.07).
Recommended dosing is 0.5 mg orally once daily for Talzenna in combination with enzalutamide (160 mg orally daily) until disease progression or unacceptable toxicity. Patients receiving this combination should also receive a gonadotropin-releasing hormone analog concurrently or should have had bilateral orchiectomy.
The most common adverse reactions (≥10 percent) included decreased hemoglobin, neutrophils, lymphocytes, platelets, calcium, sodium, phosphate, magnesium, and potassium, as well as nausea, decreased appetite, fractures, dizziness, increased bilirubin, and dysgeusia. A blood transfusion was needed among 39 percent of patients treated with Talzenna with enzalutamide, including 22 percent who required multiple transfusions.
Approval of Talzenna was granted to Pfizer.
Disclaimer: Statistical data in medical articles provide general trends and do not pertain to individuals. Individual factors can vary greatly. Always seek personalized medical advice for individual healthcare decisions.
© 2024 HealthDay. All rights reserved.
Posted June 2023
Read this next
Study Confirms Effectiveness of 'Watch-and-Wait' Approach to Prostate Cancer
THURSDAY, May 30, 2024 -- For a large percentage of men with prostate cancer, the tumor may be so slow-growing that doctors advise a "watch-and-wait" approach instead of active...
Report Highlights Big Gaps in Cancer Outcomes Based on Race
WEDNESDAY, May 15, 2024 -- U.S. cancer death rates are continuing to drop, falling by 33% between 1991 and 2020. However, not all Americans are reaping the benefits from advances...
Urine Test Might Help Men Skip Prostate Biopsies
THURSDAY, April 18, 2024 -- When prostate cancer strikes, one question is paramount: Is it aggressive and requiring immediate treatment, or slow-growing and worthy of monitoring...
More news resources
- FDA Medwatch Drug Alerts
- Daily MedNews
- News for Health Professionals
- New Drug Approvals
- New Drug Applications
- Drug Shortages
- Clinical Trial Results
- Generic Drug Approvals
Subscribe to our newsletter
Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.
