CHMP recommends earlier use of abiraterone for prostate cancer
The European Medicine Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) has now recommending extending the marketing authorisation for abiraterone (Zytiga) to include earlier stage prostate cancer.
Abiraterone is an oral antiandrogen therapy that selectively inhibits the enzyme CYP17, which is expressed in testicular, adrenal and prostatic tumour tissue and is required for androgen biosynthesis. It is given as four 250mg tablets once daily together with low-dose (10mg daily) prednisone or prednisolone.
Abiraterone is currently indicated in combination with prednisone or prednisolone for the treatment of metastatic, castration-resistant prostate cancer in men who are asymptomatic or mildly symptomatic after failure of androgen-deprivation therapy and in whom chemotherapy is not yet clinically indicated, or in men whose disease has progressed after a docetaxel-based chemotherapy regimen. If approved by the European Commission, the new licence would extend its use to the treatment of men with newly diagnosed high-risk metastatic hormone-sensitive prostate cancer (mHSPC), in combination with androgen-deprivation therapy.
In reaching its decision, the CHMP considered the results of the phase 3 LATITUDE study, which showed that adding abiraterone plus prednisone/prednisolone to androgen-deprivation therapy significantly improved overall survival and radiographic progression-free survival in men with newly diagnosed high-risk mHSPC compared with androgen-deprivation therapy alone. Severe hypertension and hypokalaemia were more common in patients taking abiraterone, therefore caution needs to be exercised when using abiraterone in men at increased risk of cardiovascular disease.