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TOPS Newsline
FDA Approves Updates to Prescribing Information for VelcadeMillennium: The Takeda Oncology Company announced that the U.S. Food and Drug Administration (FDA) has approved updates to the Velcade prescribing information that include additional long-term (median follow-up 60.1 months) overall survival data from the VISTA trial. The landmark VISTA trial examined the use of Velcade with melphalan+prednisone (MP) vs MP in patients with previously untreated multiple myeloma. Velcade is the first and only FDA-approved agent to deliver an overall survival advantage in combination with MP in patients with previously untreated MM. The 5-year follow-up data demonstrated that patients treated with Velcade+MP continued to have a significantly longer overall survival (median 56.4 months vs 43.1 months, P<0.05) than those treated with MP alone, a recognized standard of care. These results translated into a 43.9% improvement in overall survival when patients received the Velcade-containing regimen. The prescribing information is also being updated to provide the information that the concomitant use of strong CYP3A4 inducers with Velcade is not recommended. Posted 11/21/2011 Information on Drug Shortages and How You Can HelpTOPS President Larry Schlabach recently spoke with Senator Bob Corker's office regarding the current drug shortage issue. Click here to read the email from President Schlabach regarding drug shortages, as well as a letter from Senator Corker on the issue. Posted 7/14/2011 New Folotyn HCPCS CodeThe Centers for Medicare and Medicaid Services (CMS) has issued J9307, a new national permanent Healthcare Common Procedure Coding System (HCPCS) J-code for Allos Therapeutics Inc.'s FOLOTYN® (pralatrexate injection). Healthcare professionals and patients may call the Allos Support for Assisting Patients (ASAP) program for questions about the new HCPCS code, or any other coverage, coding, or payment issues related to FOLOTYN at 1-877-ASAP102. Click here for more information. Posted 12/13/2010 |
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