Janssen Korea said Tuesday it got the Ministry of Food and Drug Safety’s approval to use Zytiga (ingredient: abiraterone acetate) as a drug to treat metastatic hormone-sensitive prostate cancer (mHSPC).
Prostate cancer is the second fastest growing cancer type in Korea, with the number of patients rising around 8 percent each year. Newly diagnosed mHSPC encompasses around 60 percent of prostate cancer patients in the Asian region.
It refers to when the tumor is still responding to hormone therapy that blocks the production of a male hormone called androgen.
Zytiga is a prostate cancer prescription medication used with prednisone to treat men with cancer that has metastasized. In Korea, Zytiga had been only used to treat metastatic castration-resistant prostate cancer (mCRPC) patients with asymptomatic or mild symptoms or mCRPC patients who had previously received docetaxel-containing chemotherapy.
The ministry approved the therapy in 2012.
The newly expanded indication allows physicians and patients to use Zytiga in combination with androgen blockers (ADT) for both mCRPC and mHSPC patients.
The ministry granted the approval based on the results of a multicenter, double-blind, randomized placebo-controlled LATITUDE trial that showed significant extensions in overall survival and radiological progression-free survival.
"Providing optimized treatment options for patients at different stages of development are important because prostate cancer has different prognoses and treatments depending on the stage,” Janssen Korea CEO Jenny Zheng said. “Janssen Korea will continue to work harder to provide better treatment benefits to more Korean patients with prostate cancer in the future.”