Imnovid pomalidomide regulatory update

The U.K.'s NICE issued a preliminary appraisal recommending against use of Imnovid pomalidomide from Celgene in combination with dexamethasone to treat relapsed and refractory multiple myeloma (MM). NICE said Celgene did not provide sufficient evidence showing Imnovid is more clinically effective than current therapies. NICE also said the incremental cost-effectiveness ratio (ICER) for Imnovid was more than L50,000 ($80,215) per quality-adjusted life year (QALY) gained compared with Velcade bortezomib plus dexamethasone. Imnovid is approved for the indication in the EU in adults who have received at least 2 prior therapies, including Velcade and Celgene's Revlimid lenalidomide, and whose disease progressed while on their last therapy. Comments are due Nov. 5, and a second appraisal committee meeting is planned for Nov. 19 (see BioCentury, Aug. 12, 2013).

Pomalidomide, a thalidomide analog, has accelerated approval in the U.S. under the name Pomalyst to treat patients with MM who have received at least 2 prior therapies, including Revlimid and Velcade, and who exhibit disease progression on or within 60 days of completion of the last therapy (see BioCentury, Feb. 11, 2013). The drug is also approved in Canada. ...