The National Institutes of Health (NIH) has said that it would take "extraordinary" circumstances for the agency to address rising drug prices, even as skyrocketing costs draw criticism from patients, payers and the public. But two organizations think that it's about time for the NIH to act. And they're not mincing words with their request.
Less than a week after lawmakers asked the National Institutes of Health (NIH) and the U.S. Department of Health and Human Services (HHS) to take "extraordinary" action against rising drug prices, the agencies are getting a similar request from a nonprofit and cancer patient group. The latest target? Astellas' prostate cancer drug, Xtandi.
The U.S. arm of Tokyo-based Astellas Pharma and U.S.-listed Medivation said enzalutamide met its primary endpoint in a Phase II study to treat metastatic castration-resistant prostate cancer (mCRPC).
Astellas and Medivation's prostate cancer med Xtandi has been coming up strong behind Zytiga from Johnson & Johnson ever since hitting the market. And now, it's getting a boost in the U.K. that should help it gain more ground against its rival.
Astellas is partnering with both USA Rugby and the Australia Rugby Union for a new prostate cancer campaign. Though it's an unbranded push, the "Pass4Prostate" promotion fits right in with Astellas' stepped-up marketing of Xtandi, the prostate cancer med now approved for previously untreated patients.
After ringing up a key U.S. approval in September to threaten Johnson & Johnson's Zytiga, Astellas' Xtandi now has what it needs to ramp up its market-share battle in the EU, too.
Johnson & Johnson's next-gen prostate cancer pill, Zytiga, has been cruising since it hit the market back in April 2011, but now, it may be vulnerable to market share losses for the first time. The FDA has approved Medivation and Astellas' rival, Xtandi, for use in prostate cancer patients before chemo, giving the pill a head-to-head shot at J&J's blockbuster.
First it was good news, then it was bad news, and now it's good news again for Astellas' prostate cancer treatment Xtandi (enzalutamide) and its recommendation from the U.K.'s National Institute for Health and Care Excellence. At least it appears that way.
Astellas and Medivation today said they are asking the FDA for approval for Xtandi to be used on patients with metastatic castration-resistant prostate cancer who have not received chemotherapy.
Medivation and Astellas Pharma unveiled final results on primary and secondary efficacy endpoints from their Phase III PREVAIL trial of Xtandi (enzalutamide), showing that the drug delayed tumor growth and prolonged the lives of patients with metastatic prostate cancer who previously have not undergone chemotherapy.