Boston, MA 08/14/2014 (wallstreetpr) – A global biotechnology company, Amgen, Inc. (NASDAQ:AMGN)’s subsidiary Onyx Pharmaceuticals, Inc. disclosed that the favorable results of ASPIRE stage three clinical trial would be enough to support regulatory submissions throughout the world on Kyprolis in patients affected by relapsed and advanced refractory multiple myeloma.
ASPIRE
Kyprolis was given approval by the U.S. Food and Drug Administration or FDA on July 20 in 2012 for the treatment of advanced multiple myeloma in the U.S. after the company presented data supporting that patients responded to the drug. The injection was meant for those patients who must have received a minimum of two therapies such as Immunomodulatory agent or IMiD and bortezmib and that should have confirmed disease progression within two months of the last therapy completion. The FDA approval depended on response rate while clinical gains like survival improvement or symptoms were not verified for survival of clinical benefit.
Amgen, Inc. (NASDAQ:AMGN) believes that the recent positive ASPIRE stage three clinical study would be enough to take care of the regulatory submissions worldwide. The approval given by the FDA in the U.S. should also come in handy while approaching regulators in the rest of the world.
Multiple Myeloma
Amazon’s subsidiary disclosed that multiple myeloma was the second-most-common form of hematologic cancer due to an abnormality of plasma cells, normally in the bone marrow. There were about 70K people in the U.S. with multiple myeloma and about 24K new cases were diagnosed every year. Globally, an estimated 230K people were living with multiple myeloma. Of this, about 114K fresh cases were diagnosed every year.
FOCUS
Amgen, Inc. (NASDAQ:AMGN) had called FOCUS about its phase three clinical trial for the evaluation of single agent Kyprolis compared to low-dose steroids of an active control regimen plus optional cyclophosphamide in patients suffering from relapsed and advanced refractory multiple myeloma after undergoing a minimum of three therapies.
On Wednesday after the market closed, the company disclosed that its stage three clinical study FOCUS had failed to meet its primary endpoint of enhanced survival. The results were announced after conducting a study with the 315 patients. As a result, the stock slipped in the red in the extended hours of trading on Wednesday.
