Xtandi gets EU approval
pharmafile | June 26, 2013 | News story | Sales and Marketing | Astellas, FDA, Xtandi
Astellas Pharma’s Xtandi has been approved in the European Union for the treatment of adult men with advanced prostate cancer, a group with relatively few existing therapy options.
The capsule had been given the thumbs-up by the CHMP in April and can now be used in adult males with a metastatic castration-resistant form of the disease (mCRPC) which has progressed on or after docetaxel therapy.
Around 10-20% of patients present at an advanced stage, and up to 40% will eventually develop the advanced disease – and many form a resistance to androgen deprivation treatment (hence have the castration-resistant form).
Xtandi is widely tipped to be a blockbuster, thanks to impressive data showing it extended life of patients: analysts forecast that it could earn $1-2 billion in peak sales, and will provide competition to J&J’s Zytiga, which has been on the market since 2011.
Xtandi (enzalutamide) is a novel, once-daily, inhibitor of the androgen receptor (AR) signalling pathway and has been shown in the Phase III AFFIRM study to decrease cancer cell growth and induce cancer cell death (apoptosis).
Patients in the trial had a median survival time of 18.4 months – an increase of 4.8 months on those in the placebo arm – and its European authorisation is the trigger for Astellas to make a milestone payment of $15 million to development partner Medivation.
“A new treatment such as enzalutamide is one more option that will give selected patients a new chance if other options fail,” said Dr Erik Briers, executive director of the European Cancer Patient Coalition.
“Patients with advanced prostate cancer are very concerned about their quality of life, so they favour treatments with fewer side effects,” he went on. “Enzalutamide has been shown to be generally well tolerated.”
The FDA approved the drug in September last year for patients with mCRPC who have previously received docetaxel.
Adam Hill
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