NICE issues second draft guidance on PIXUVRI for treatment of aggressive B-cell NHL

Cell Therapeutics, Inc.Oct 15 2013

Cell Therapeutics, Inc. (CTI) (NASDAQ and MTA: CTIC) today announced that the National Institute for Health and Care Excellence (NICE), a non-departmental public body of the Department of Health in the United Kingdom (UK), issued second draft guidance on PIXUVRI^® (pixantrone) as a monotherapy for the treatment of adult patients with multiply relapsed or refractory aggressive B-cell non-Hodgkin lymphoma (aggressive B-cell NHL).  NICE's independent Appraisal Committee met on September 11, 2013, to consider the cost effectiveness of pixantrone taking into consideration CTI's initial patient access scheme that was approved by the Department of Health in July 2013.  The result is a second appraisal consultation document, or ACD, whereby the Committee concluded that this scheme does not overcome the uncertainties in the evidence for pixantrone's (PIXUVRI) clinical effectiveness and once again requests that consultees, including CTI, healthcare professionals and members of the public, comment on the draft guidance via the NICE website.  The ACD consultation will close on November 4, 2013, and any comments received will be considered by the NICE appraisal committee to enable them to develop the next stage of guidance.  It should be noted that this is not NICE's final guidance on pixantrone and that a third Appraisal Committee meeting is expected to be held on November 13, 2013, where subject to approval, CTI hopes the Committee will consider  an 'enhanced' patient access scheme to demonstrate the cost effectiveness of pixantrone for use by the NHS in the UK.

In May 2012, the European Commission (EC) granted conditional marketing authorization in the European Union (E.U.) for PIXUVRI as a monotherapy for adult patients with multiply relapsed or refractory aggressive B-cell NHL based on the results of the EXTEND, or PIX301, pivotal randomized Phase 3 clinical trial.  PIXUVRI was made available to patients in eight countries in the European Union in the fourth quarter of 2012, and some patients in other countries have already started to receive the treatment.  Prior to the approval of PIXUVRI in the E.U., there were no approved agents or standard of care in this stage of the disease.  The PIX301 trial was designed utilizing agents in the comparator arm that have anti-tumor activity in relapsed disease and are typically employed as palliative therapy for these patients.

"We look forward to collaborating with NICE during the final stage of the process as we seek to bring this new approved therapy to patients in the UK with aggressive non-Hodgkin lymphoma in the 3^rd line salvage setting," said James A. Bianco, M.D., President and CEO of CTI.