11.2 months with placebo plus best standard of care (95% CI: 9.0-13.2). Xofigo significantly improved OS in the overall study population at the pre-specified interim analysis (HR=0.695, (95% CI 0.552-0.875), p=0.00185) median OS was 14.0 months with Xofigo plus best standard of care (95% CI: 12.1-15.8) vs. There were no scheduled radiographic assessments performed on study. SSE was defined as first use of external beam radiation therapy to relieve skeletal pain, new symptomatic pathologic bone fracture, occurrence of spinal cord compression or tumor-related orthopedic surgical intervention. A key secondary endpoint was time to first symptomatic skeletal event (SSE). The primary endpoint of the study was overall survival (OS). The study treatment consisted of up to six intravenous injections of Xofigo or placebo each separated by an interval of four weeks. Patients were stratified based on their baseline alkaline phosphatase (ALP) level, current bisphosphonate use and whether or not they had received docetaxel prior to study enrollment. The trial enrolled 921 patients in more than 100 centers in 19 countries. placebo plus best standard of care in patients with CRPC, symptomatic bone metastases and no known visceral metastatic disease. The European Marketing Authorization is based on data from ALSYMPCA, a phase III, randomized, double-blind, placebo-controlled international study of Xofigo plus best standard of care vs. Algeta is eligible for royalties and milestones based on Bayer's sales of Xofigo outside the US, and Algeta US, LLC is co-promoting Xofigo with Bayer in the US. Under the terms of this agreement, Bayer will develop, apply for health authority approvals worldwide and commercialize Xofigo globally. In September 2009, Algeta signed an agreement with Bayer for the development and commercialization of Xofigo. More importantly, Xofigo's approval in Europe highlights the need for new therapies for castration-resistant prostate cancer patients with symptomatic bone metastases." It marks the start of what we hope will become an important royalty stream based on Bayer's ex-US sales, in addition to the 50% share of the profits we expect to receive from the co-promotion of Xofigo in the US. The approval of Xofigo is based on data from the pivotal Phase III ALSYMPCA ( AL pharadin in SYM ptomatic P rostate CA ncer) trial.Īndrew Kay, Algeta's President & CEO, said: "Today's decision by the European Commission to approve Xofigo in the EU is another major milestone achieved for Algeta. Xofigo was approved by the US Food and Drug Administration in May 2013 for the treatment of patients with castration-resistant prostate cancer, symptomatic bone metastases and no known visceral metastatic disease and is now available in the United States at licensed facilities. This decision follows a positive recommendation from the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) in September of this year. The marketing authorization provides approval for the commercialization of Xofigo in all 28 countries of the EU, and in Norway, Iceland and Liechtenstein following national approval. Oslo, Norway, 15 November 2013 - Algeta ASA (OSE: ALGETA) announces today that Bayer has received marketing authorisation from the European Commission for Xofigo ® (radium Ra 223 dichloride) solution for injection for the treatment of adults with castration-resistant prostate cancer, symptomatic bone metastases and no known visceral metastases. Xofigo ® (radium Ra 223 dichloride) injection granted Marketing Authorization in the European Union
0 Comments
Leave a Reply. |
AuthorWrite something about yourself. No need to be fancy, just an overview. ArchivesCategories |