Zytiga approved for use before chemotherapy

The licence for Zytiga (abiraterone) has been extended to include patients with metastatic castration-resistant prostate cancer who are asymptomatic or mildly symptomatic for whom chemotherapy is not yet indicated.

Abiraterone inhibits the synthesis of androgens in testicular, adrenal and prostatic tumour tissues | SCIENCE PHOTO LIBRARY
Zytiga is used in the same licensed dosage regimen as in patients whose cancer has progressed following or during chemotherapy: 1g (four tablets) once daily at least one hour before or two hours after food, in combination with prednisolone.

The safety and efficacy of abiraterone in chemotherapy-naïve patients (n=1,088) was established in a randomised, placebo-controlled phase III study (COU-AA-302) using the co-primary endpoints of radiographic progression-free survival (PFS) and overall survival. Patients were either using an LHRH analogue or had previously undergone orchidectomy.

Progression-free survival doubled

The study was unblinded when 43% of the expected deaths had occurred following a preplanned interim analysis. The median radiographic PFS was doubled in patients receiving abiraterone compared with placebo: 16.5 months vs 8.3 months (HR 0.53, 95% CI 0.45–0.62, p<0.001). Abiraterone also improved overall survival but did not cross the efficacy boundary.

Serious mineralocorticoid-related adverse events and liver-function abnormalities were more common in the abiraterone arm.

View Zytiga drug record

Further information: Janssen-Cilag Ltd

Follow MIMS on Twitter


Want news like this straight to your inbox?
Sign up for our bulletins

Have you registered with us yet?

Register now to enjoy more articles and free email bulletins

Register
Already registered?
Sign in

More from MIMS

Products coming soon - live tracker

EXCLUSIVE TO SUBSCRIBERS Monitor forthcoming UK drug...

Drug shortages - live tracker

EXCLUSIVE TO SUBSCRIBERS Use our constantly updated...

Back of man's head suffering from alopecia

Alopecia drug to be available on the NHS

In an NHS first, NICE is recommending ritlecitinib...

Stressed male GP with hand on head