FDA warns Takeda about Velcade reminderletter, dated June 18.
“We acknowledge that the mailer uses the term ‘complete response' as a double-entendre, with the term also being used in the context of this piece to mean a ‘response' by meeting attendees consisting of a visit to the Velcade booth and a swiping of the card attached to the mailer…in exchange for Millennium making a donation to a cancer organization,” the letter read. “However, the existence of this second meaning for the term does not make its use appropriate in a reminder piece given that its primary meaning in the oncology setting makes representations or suggestions about the drug.”
The letter notes that other non-reminder promotional materials for Velcade use the phrase “complete response,” or CR, to mean “the disappearance of all detectable signs of cancer in response to treatment.”
The second issue in the letter, regarding overstated efficacy, describes pictures of a crowd of men and women in conjunction with the claim, “Achieve a Complete Response,” which suggests that “patients treated with Velcade therapy are likely to achieve a complete hematological or clinical response,” the letter said. According to several clinical studies sited in the letter, the rate of complete response was significantly below 100%.
Velcade, a product of Takeda's Millenium pharmaceuticals unit, is an injectable indicated as a first and second line treatment for patients with multiple myeloma, and a second line treatment for mantle cell lymphoma.
Reporting for BNET, Jim Edwards noted that PhRMA guidelines ban reminder ads on television, but allow them for professional use.