CHMP releases positive opinion of XTANDI for European Label

Astellas Pharma Inc. and Medivation Inc. recently reported that the Committee for Medicinal Products for Human Use (CHMP), a branch of the European Medicines Agency (EMA), has released a positive opinion recommendation of XTANDI.


Astellas Pharma Inc. and Medivation Inc. recently reported that the Committee for Medicinal Products for Human Use (CHMP), a branch of the European Medicines Agency (EMA), has released a positive opinion recommendation of XTANDI.

The recommendation applies to the approval of the companies’ type II variation of XTANDI due to its head-to-head TERRAIN trial data. The enzalutamide versus bicalutamide capsules can use this approval to earn a European label.

"We are pleased that the CHMP has recommended inclusion of the TERRAIN data in the European label for XTANDI," Dr. Claire Thom, SVP and oncology therapeutic head for Astellas, said.

The TERRAIN study involved 375 patients from Europe and North America. All of the patients had metastatic prostate cancer, and their disease had continued to progress despite any treatments from luteinizing hormone-releasing hormone (LHRH) analogue therapy. Their disease also continued after surgical castration.

The trial demonstrated that there was a statistically significant progress-free survival (PFS) rate for patients who received the new treatments.

"We are very pleased with the CHMP's decision to update the XTANDI label to include these data," Dr. David Hung, founder, president and CEO of Medivation, said. "TERRAIN was the first and largest head-to-head trial comparing enzalutamide against bicalutamide in the treatment of patients with metastatic castration-resistant prostate cancer (CRPC)."

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