NCOA Newsfeed
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FDA Approves Updates to Prescribing Information for Velcade
November 21, 2011. Millennium: 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.
NCOA Expresses Concern About Drug Shortages
On behalf of its members and cancer patients in North Carolina, the Board of Directors recently sent a letter of concern about state and national shortages of chemotherapeutics and related drugs for cancer treatment to North Carolina’s elected representatives in the US Congress. The letter also contained support for federal legislation, S. 296, Preserving Access to Life-Saving Medications, which addresses these shortages. The same letter of concern also was sent to representatives of four pharmaceutical companies and officials at the Food and Drug Administration (FDA).
To view the NCOA letter, please click here. NCOA members are encouraged to also write their elected representatives in Washington, DC in support of S. 296 and to share with them the problems these shortages are causing in planning the most effective treatment regimens for patients. In addition, members should report any shortages their practices are experiencing to the FDA at http://www.fda.gov/drugs/drugsafety/drugshortages/ucm050792.htm.
NCOA’s letter has already elicited a response from APP Pharmaceuticals. Please click here to see the letter from APP President and CEO, John Ducker.Fair Contracting Practices
