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
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

Register or Subscribe to MIMS

GPs can get MIMS print & online and GPonline for free when they register online – take 2 minutes, and make sure you get your free MIMS access! If you're not a GP, you can subscribe to MIMS for full access.

Register or subscribe

MIMS Dermatology

Read the latest issue online exclusively on MIMS Learning.

Read MIMS Dermatology

MIMS Adviser

Especially created for prescribing influencers.

Request free copy

Mobile apps

MIMS: access the full drug database and quick-reference tables on the go

MIMS Diagnosis and Management: concise information on signs and symptoms, investigations and diseases