Prostate cancer drug Zytiga gains US approval
pharmafile | May 5, 2011 | News story | Sales and Marketing | Centocor Ortho Biotech, Johnson & Johnson, Zytiga, prostate cancer
Zytiga a new treatment for the most hard to treat cases of prostate cancer has been approved in the US.
Marketed by J&J subsidiary Centocor Ortho Biotech, Zytiga (abiraterone acetate) has been shown to help men with advanced prostate cancer live longer compared to existing treatments.
The oral, once-daily treatment is for use in combination with prednisone for metastatic castration-resistant prostate cancer patients who have received prior chemotherapy containing docetaxel.
Analysts predict the drug will reach peak sales of between $800 and $1 billion, but will have to compete with another new entry to the prostate cancer market, Sanofi’s Jevtana.
Zytiga is an oral treatment, compared to the traditional chemotherapy formulation of Jevtana, which should give it the edge over Sanofi’s drug.
Zytiga works by suppressing androgens, the male hormones which can help fuel the tumour’s growth. The drug is an oral androgen biosynthesis inhibitor that works by inhibiting the CYP17 enzyme complex, which fuels androgen production in the testes, adrenal glands and the tumour tissue.
“This FDA approval represents a welcome new option in the treatment of metastatic prostate cancer,” said Howard Scher, chief of the Genitourinary Oncology Service, Sidney Kimmel Center for Urologic and Prostate Cancers at Memorial Sloan-Kettering, and one of the co-lead investigators for the phase III clinical study.
“As a clinician, I believe the efficacy and safety profile of abiraterone acetate, as well as its oral, once-daily formulation, will help address the important need for additional therapeutic choices for men living with this serious disease.”
“In a phase III study, treatment with Zytiga plus prednisone showed a significant increase in median survival compared with placebo plus prednisone,” said Professor Johann de Bono, The Institute of Cancer Research, The Royal Marsden NHS Foundation Trust, and also a co-lead investigator for the phase III clinical study. “It’s an exciting time for men with prostate cancer, and I believe that Zytiga will play an essential role in clinical practice.”
Results of the pivotal phase III trial showed that at pre-specified interim analysis, treatment with Zytiga in combination with prednisone resulted in a 35% reduction in the risk of death (14.8 months vs. 10.9 months [hazard ratio (HR) = 0.646; 95% CI: 0.543, 0.768; p<0.0001]) and a 3.9 month difference in median survival compared to placebo plus prednisone.
In an updated analysis, results were consistent with those from the interim analysis with a 4.6 month difference between the two arms in median survival (15.8 months vs. 11.2 months [HR = 0.74]).
At a predetermined number of events in the study, an interim analysis was conducted and it was determined that efficacy had been demonstrated. At that time, the study was unblinded at the recommendation of the Independent Data Monitoring Committee.
The most common adverse reactions (greater than or equal to 5 %) reported in the clinical study were: joint swelling or discomfort, hypokalemia, oedema, muscle discomfort, hot flush, diarrohea, urinary tract infection, cough, hypertension, arrhythmia, urinary frequency, nocturia, dyspepsia and upper respiratory tract infection.
Andrew McConaghie
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