Astellas Pharma’s Xtandi (ingredient: enzalutamide), the latecomer drug that expanded indication for metastatic hormone-sensitive prostate cancer (mHSPC), scored the U.K.’s recommendation for reimbursement.

The recommendation for Xtandi came faster than rival drugs Janssen’s Zytiga (abiraterone acetate) and Erleada (apalutamide), which expanded the indication for mHSPC earlier.

The U.K. National Institute for Health and Care Excellence (NICE) recently recommended the reimbursement for Xtandi for patients with mHSPC along with standard androgen deprivation therapy (ADT).

Astellas Pharma’s Xtandi (ingredient: enzalutamide) scored the U.K.’s recommendation for reimbursement in metastatic hormone-sensitive prostate cancer.
Astellas Pharma’s Xtandi (ingredient: enzalutamide) scored the U.K.’s recommendation for reimbursement in metastatic hormone-sensitive prostate cancer.

The decision came in just one month after Xtandi obtained the indication for mHSPC in the U.K. in May.

It is not yet clear whether Xtandi has prolonged overall survival (OS) compared to the existing standard chemotherapy. Still, NICE has reportedly judged that the drug should be reimbursable given its cost-effectiveness.

NICE rejected the reimbursement for Janssen’s Zytiga last year and Erleada in late May, although the two drugs won the indication for mHSPC earlier than Xtandi.

Among various types of metastatic prostate cancer, mHSPC is the most common. The endorsement for Xtandi reimbursement will help about 8,500 men unsuitable for the standard chemotherapy to get a new treatment, NICE said.

Securing insurance benefits first in the mHSPC treatment market with the highest demand, Xtandi is likely to outrun Janssen’s rival products and dominate the British prostate cancer market, observers said.

Androgen receptor inhibitors (ARIs) such as Xtandi were developed for patients with castration-resistant prostate cancer whose prostate-specific antigen (PSA) levels continue to rise despite ADT, a hormone therapy.

Xtandi won approval first as monotherapy for the treatment of non-metastatic or metastatic castration-resistant patients. Recently, it added an indication for mHSPC with the largest demand.

The NICE’s decision on the reimbursement was based on late-stage clinical trials that compared ADT plux Xtandi with ADT alone in mHSPC patients.

The additional administration of Xtandi reduced the risk of disease progression and death by 61 percent, compared to ADT monotherapy.

Copyright © KBR Unauthorized reproduction, redistribution prohibited