Posted by Michael Wonder on 16 Feb 2018
Health Canada approves new indication for Zytiga (abiraterone acetate), broadening its use for treatment of newly diagnosed metastatic prostate cancer
15 February 2018 - Zytiga, used in combination with prednisone and androgen deprivation therapy, was shown to reduce the risk of death by 38%.
The Janssen Pharmaceutical Companies of Johnson & Johnson today announced Health Canada's approval of Zytiga (abiraterone acetate) in combination with prednisone and androgen deprivation therapy (ADT) for the treatment of patients with newly diagnosed, high-risk metastatic hormone-sensitive prostate cancer (mHSPC) who may have received up to three months of prior ADT.
This latest approval is based on Phase 3 data from the pivotal LATITUDE clinical trial, a multinational, multicenter, randomized, double-blind, placebo-controlled trial (N=1,199) that examined the use of Zytiga 1,000 mg once daily in combination with prednisone 5 mg once daily and ADT, compared to placebos plus ADT in patients with newly diagnosed mHSPC.3 The study showed Zytiga, in combination with prednisone and ADT reduced the risk of death by 38% compared to placebo plus ADT (median OS not reached vs. 34.7 months, respectively; HR=0.62; 95% confidence interval [CI], 0.51 to 0.76; P<0.001) in patients with mHSPC.
