March 2011 PBAC Outcomes - Deferrals

Bortezomib, powder for injection, 1 mg (solvent required), Velcade®

Janssen – Cilag Pty Ltd

Major submission                     

Multiple myeloma

Authority Required
Initial and continuing treatment as monotherapy or in combination with a corticosteroid and melphalan or cyclophosphamide in a patient with symptomatic multiple myeloma and severe renal impairment (GFR ? 30, after adequate hydration) who
(1) is newly diagnosed and receiving bortezomib as front line therapy, or
(2) who commenced treatment on thalidomide with a resultant GFR drop to ? 30.

The PBAC deferred the submission to enable discussion with clinicians and the sponsor regarding eligibility criteria for first-line use in a patient with acute renal failure whose GFR is falling and where a renal physician would consider the patient at risk of requiring dialysis, so that those with the greatest clinical need will have access to PBS-subsidised bortezomib. 

Sponsor’s comments:

The sponsor has no comment.