FDA approves update of prescription label information for ammo MM-targeted drug Kyprolis (carzofilmib)
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Last Update: 2020-06-11
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Source: Internet
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Author: User
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recently, Amgen announced that the U.SFood andDrug(
FDA
(
FDA) has approved the multiple myeloma (MM) targeted drug Kyprolis (carfilzomib) prescription label information update, including phase III clinical research ASPIRE active total survival (OS) datathe study was conducted in patients with recurrent or refractory MM, and the data showed that the Kyprolis-Toysamine-Dexamenotristristrison tridrugregimecan(Rd) two-drug regimen reduction in risk of death by 21% compared to the Two-Drug Treatment Program of Nalamine-Dexametisone (Rd) OS is extended by 7.9 months (median OS: 48.3 months vs 40.4 months, HR: 0.79, 95% CI: 0.67-0.95, bilateral test p.0.0091)about Kyprolis
Kyprolis is an inverse protease inhibitor of intravenous administrationIn the United States, Kyprolis's current indications are: (1) combined with dexamethasone or combined with dexamethasone and dexamethasone for recurrent or refractory MM patients who have previously received first- to third-line therapy;in January, the FDA also approved the Kyprolis label update to include OS data for ENDEAVOR, another key Phase III clinical studythis study was the first head-to-head study designed by Amin against Takeda MM-targeted drug Velcade (commodity name: Vantain, generic name: bortezomib, bortezozomi), conducted in patients with recurrent multiple myeloma (RMM) who had previously received at least one program but no more than 3 programmes, and compared the Kyprolis s dexametne (Kdd) and Velcade .Vdstudies show that Kd significantly longer OS and 21% significantly reduced the risk of death compared to Vd (median OS: 47.6 months vs 40.0 months; HR s 0.79; p?01)In addition, the OS benefit has nothing to do with whether the patient has received Velcade treatment in the pastKyprolis was approved in 2012 and has so far received treatment for more than 80,000 patients worldwideKyprolis' clinical development program continues to focus on providing solutions to doctors and patients for this frequent recurrence and difficult ymid-treatment cancer
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