On Friday, Johnson & Johnson's Zytiga received an expanded approval from the European Commission. The drug was previously approved for patients with metastatic castration-resistant prostate cancer who have failed a chemotherapy regimen that contains Sanofi's Taxotere. The new approval expands the use of Zytiga into patients who have failed androgen deprivation therapy, but who aren't appropriate for chemotherapy yet.
The European Commission's decision is a rubber stamp on the European Medicines Agency's Committee for Medical Products for Human Use's decision in November to recommend the expanded marketing authorization.
The expanded approval is based on a clinical trial of more than 1,000 patients comparing Zytiga, plus prednisone/prednisolone, to placebo, plus prednisone/prednisolone. Patients in the Zytiga arm had a statistically-significant improvement in radiographic progression-free survival, a measure of how quickly a tumor begins to grow. Treatment with Zytiga also produced longer overall survival, although the trial was stopped early, so the difference didn't reach statistical significance.
The article J&J's Prostate Cancer Drug Zytiga Approved for Earlier Use in EU originally appeared on Fool.com.Brian Orelli has no position in any stocks mentioned. The Motley Fool recommends Johnson & Johnson. The Motley Fool owns shares of Johnson & Johnson. Try any of our Foolish newsletter services free for 30 days. We Fools may not all hold the same opinions, but we all believe that considering a diverse range of insights makes us better investors. The Motley Fool has a disclosure policy.
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