The NCCN guidelines for a cancerX recommended products of class A for Stages III-IV in line with the recommended label. However, they have just been updated to include same products for Stages II-IV, recognizing that "supporting data are limited for stage II". The rationale for this revision / inclusion is the following: "Cases of stage II disease at initial diagnosis are rare, especially among patients who have undergone complete surgical staging, so there are little data and low probability of future trials that will address the question of whether it is appropriate to use class A as maintenance after completing primary therapy for stage II disease." Our question to the PAAB is whether we can use these new recommendations as part of the promotional materials with a disclaimer that our indication is for "advanced stages of cancerX".
Jennifer Carroll last edited by
Generally, promotion of place in therapy claims from consensus guidelines should be within the limitations of the indication and terms of market authorization. As it sounds like this is an off-label recommendation, it would not be acceptable. The Marketing Benefits Claims document also includes this definition.