Astellas, Medivation's Xtandi shows significant benefit in pre-chemo prostate cancer patients
This article was originally published in Scrip
Astellas Pharma and Medivation’s prostate cancer drug Xtandi showed a significant benefit by extending lives and preventing the disease from worsening in patients who were not yet treated with chemotherapy, new data show.
The strong results support the companies' plans to win approval for expanded use of its drug, which competes with Johnson & Johnson’s Zytiga. In a study of more than 1,700 men with metastatic prostate cancer, Xtandi (enzalutamide) met both study goals of extending overall survival and halting progression of the disease. The study was stopped in October because of high efficacy.
Investigators said on January 28 that Xtandi reduced the risk of death by 29% compared with placebo and halted progression of the disease by 81%. Xtandi delayed the median time to chemotherapy by 17 months. The drug was relatively well tolerated, researchers said. The results are being presented this week at the American Society of Clinical Oncology’s Genitourinary Cancers Symposium in San Francisco.
“These are extremely strong data,” BioMedTracker analyst Robert Jeng told Scrip.
Dr Jeng said the results “should easily lead to regulatory approval” for patients who haven’t received chemotherapy. Xtandi already is approved for men who previously received chemo. Zytiga (abiraterone) was approved in the US and Europe last year to add the pre-chemo indication.
First approved in 2011, Zytiga generated $1.7 billion in sales last year. Xtandi reported about $283 million through nine months last year. Full-year sales are not yet available.
Astellas and Medivation will seek US and European approval to broaden Xtandi’s label early this year, the companies said.
If the drug is approved for the broader use, “it will be a meaningful advance in the field of prostate cancer therapy,” Medivation CEO David Hung said.
Medivation shares jumped 12% in after-hours trading following the announcement of the study results. The stock already had jumped by more than a third in the past six months.