Astellas Pharma Korea said it obtained regulatory approval for Xtandi (ingredient: enzalutamide)’s expanded indication against non-metastatic castration-resistant prostate cancer as of Feb. 7.
With the additional indication, Xtandi became the first targeted therapy for castration-resistant prostate cancer, regardless of metastasis.
Xtandi had previously been used to treat patients treated with docetaxel or those with metastatic castration-resistant prostate cancer (mCRPC) with no symptom or mild symptoms.
The additional indication allows physicians to use the treatment for high-risk non-metastatic castration-resistant prostate cancer.
The approval was based on a phase-3, randomized, double-blind trial, called PROSPER, on 1,401 patients with non-metastatic castration-resistant prostate cancer.
The trials’ result showed that the median metastatic-free survival of patients treated with Xtandi and androgen deprivation therapy (ADT) stood at 36.6 months, compared to that of the placebo and ADT group at 14.7 months. The combined therapy of Xtandi and ADT lowered the risk of metastasis by 71 percent, compared to the monotherapy of ADT.
Kwak Cheol, head of the prostate cancer research committee at the Korean Urological Oncology Society, said Xtandi proved efficacy and safety in non-metastatic castration-resistant prostate cancer in the PROSPER trial.
“Having an indication for both metastatic and non-metastatic castration-resistant prostate cancer, Xtandi will offer treatment options for more patients,” he said.
Astellas Pharma Korea won the nod for Xtandi in June 2013 for the treatment of patients with metastatic castration-resistant prostate cancer who have been treated with docetaxel. The drugmaker won the insurance benefit for Xtandi in November 2014 under a risk-sharing agreement (RSA) and renewed the RSA in February to extend the deal until January 2023.
In May 2015, the company gained Xtandi’s indication for metastatic castration-resistant prostate cancer patients with no symptom or mild symptoms.
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