January 21, 2020
1 min read

FDA grants priority review to Lynparza for prostate cancer subtype

You've successfully added to your alerts. You will receive an email when new content is published.

Click Here to Manage Email Alerts

We were unable to process your request. Please try again later. If you continue to have this issue please contact customerservice@slackinc.com.

The FDA granted priority review to olaparib for the treatment of men with metastatic castration-resistant prostate cancer and homologous recombination repair gene mutations who progressed on treatment with a new hormonal agent, according to a press release from the agent’s manufacturers.

Olaparib (Lynparza; AstraZeneca, Merck) is a poly(ADP-ribose) polymerase (PARP) inhibitor.

The FDA based its decision, in part, on data from the randomized phase 3 PROfound study presented in September at European Society for Medical Oncology Congress.

The trial met its primary endpoint, based on significantly longer median radiographic PFS among men with BRCA1/BRCA2- or ATM-mutated metastatic castration-resistant prostate cancer assigned olaparib vs. physician’s choice of enzalutamide (Xtandi; Astellas, Pfizer) or abiraterone acetate (Zytiga, Janssen; 7.4 months vs. 3.6 months; HR = 0.34; 95% CI, 0.25-0.47).

Olaparib also was associated with longer radiographic PFS among the overall population of men with homologous recombination repair-mutated disease, including those with BRCA1/BRCA2, ATM, CDK12 or 11 other mutations (5.8 months vs. 3.5 months; HR = 0.49; 95% CI, 0.38-0.63).

The most common adverse events associated with olaparib vs. abiraterone or enzalutamide included anemia (47% vs.15%), nausea (41% vs. 19%), fatigue and asthenia (41% vs. 32%), decreased appetite (30% vs. 18%) and diarrhea (21% vs. 7%). Grade 3 or worse adverse events observed on the trial included anemia (22% vs. 5%), fatigue and asthenia (3% vs. 5%), vomiting (2% vs. 1%), dyspnea (2% vs. 0%), urinary tract infection (2% vs. 4%), nausea (1% vs. 0%), decreased appetite (1% each), diarrhea (1% vs. 0%) and back pain (1% vs. 2%).

More patients assigned olaparib vs. abiraterone or enzalutamide experienced an adverse event that led to dose interruptions (22% vs. 4%) or treatment discontinuation (16% vs. 9%).

The FDA is expected to make a decision on this application by the second quarter of 2020.