Oral Anti-Cancer Therapy Pomalidomide Now Approved by European Commission as Treatment

Oral Anti-Cancer Therapy Pomalidomide Now Approved by European Commission as Treatment for Patients with Relapsed/Refractory Multiple Myeloma – a Rare Form of Blood Cancer Celgene International Sàrl, a wholly-owned subsidiary of Celgene Corporation announced that the European Commission (EC) has granted approval for Pomalidomide Celgene (pomalidomide), in combination with dexamethasone, for the treatment of relapsed and refractory multiple myeloma (rrMM) in adult patients who have received at least two prior therapies including both lenalidomide and bortezomib and have demonstrated disease progression on the last therapy.1 Celgene intends to launch Pomalidomide Celgene in the EU under the trade name “IMNOVID®”,following submission of a regulatory notification to the European Medicines Agency (EMA) to change the trade name. Multiple myeloma is a blood cancer where plasma cells, important components of the immune system which are responsible for making antibodies that help fight infections, replicate uncontrollably and accumulate in the bone marrow.2 Almost all patients with multiple myeloma have a risk of eventual relapse, which means their disease may progress even if they have achieved initial response to treatment.2,3 “Most patients diagnosed with multiple myeloma will relapse at some point and I have seen many patients who have become refractory to a number of treatments. The urgency now is to develop novel agents that help those patients who have tried several therapies and exhausted current standards of care” said Dr Xavier Leleu, Hôpital Huriez, CHRU Lille, France. “The approval of pomalidomide, one of these novel agents, is great news and a major step forward for these patients across Europe who need a new effective treatment option to help manage their disease.” Adds Alan Colowick, President of Celgene Europe, the Middle East and Africa (EMEA): “We are committed to developing life-changing medicines for those living with rare diseases. With today’s approval, Celgene becomes one of the few companies to deliver treatments across all stages of multiple myeloma, right from the start at diagnosis, through to the support that pomalidomide can now offer late-stage multiple myeloma patients who have exhausted other treatment options.” The EC’s decision was based on the results from the MM-003 study, a phase III, multi-center, randomized (2:1), open-label study in 455 patients.1 The results demonstrated significantly improved median progression-free survival of 15.7 weeks (p<0.001) for patients with rrMM who were treated with pomalidomide plus low-dose dexamethasone, compared with 8.0 weeks (p<0.001) for those treated with high-dose dexamethasone only (data cutoff 07/09/12).1 Median overall survival was also significantly improved for the pomalidomide plus low-dose dexamethasone arm, compared with high-dose dexamethasone only, (median not reached vs. 34 weeks; p<0.001).1 The most commonly reported Grade 3 or 4 adverse reactions included neutropenia, thrombocytopenia and infections. The decision follows the positive opinion issued by the Committee for Medicinal Products for Human Use (CHMP) in May 2013.4 Pomalidomide will be launched in the European Union under the name “IMNOVID” according to local requirements. http://newsroom.celgene.com/press-release/oral-anti-cancer-therapy-pomalidomide-now-approved-european-commission-treatment-patie Project Name Oral Anti-Cancer Therapy Pomalidomide Now Approved by European Commission as Treatment Location USA Commence 2013 Completion -NA- Estimated Investment -NA- Capacity -NA- Key Players Oral Anti-Cancer Therapy Pomalidomide