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Astellas prostate cancer drug gets third approval from MHRA

Published on 12/05/21 at 11:20am
MHRA sign

The MHRA has approved Astellas Pharma’s XTANDI (enzalutamide) drug for the treatment of a third form of prostate cancer, making it the only oral therapy approved by the agency for three different types of the illness.

The treatment is now also approved for adult men with metastatic hormone-sensitive prostate cancer (mHSPC). This kind of cancer means the illness has spread past the prostate into the body. 

Men diagnosed with mHSPC currently tend to have a poor prognosis, with a median survival of approximately 3-4 years.

The MHRA approval is based on results from the Phase III ARCHES trial, which evaluated XTANDI in men with mHSPC.

The study showed XTANDI, plus androgen deprivation therapy (ADT), significantly reduced the risk of radiographic progression or death by 61% – versus placebo plus ADT – in men with mHSPC.

XTANDI is already approved in the UK for the treatment of high risk non-metastatic and metastatic castration-resistant prostate cancer. These are cancers that keep growing despite the amount of testosterone in the body being reduced to very low levels.

Dr Andrew Krivoshik PhD, Senior Vice President and Global Therapeutic Area Head, Oncology Development at Astellas, added: “Enzalutamide has been an established standard of care for men with advanced prostate cancer and has been prescribed to more than 610,000 patients worldwide since it was first approved in 2012.

“This new indication for enzalutamide provides men with mHSPC a much-needed, additional therapy option earlier in their treatment journey.”

Dr Andrew Armstrong, Professor of Medicine, Surgery, Pharmacology and Cancer Biology, and Lead Investigator of the ARCHES trial, said: “Metastatic hormone-sensitive prostate cancer patients have limited options and, unfortunately, there is a poor prognosis for many men. 

“The research supporting this approval provides clinical evidence showing how enzalutamide can help improve outcomes for men with mHSPC, which gives healthcare professionals in Europe the option to offer the treatment across the advanced prostate cancer disease continuum.”

Jack Goddard

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