POMALYST Is A New Option For Patients Whose Disease Has Progressed Despite Treatment With Available Therapies

Mississauga, Ontario (Press Release) - Health Canada has approved POMALYST™ oral ther­apy (poma­lido­mide capsules) in com­bi­na­tion with dexa­meth­a­sone, for patients with multiple myeloma for whom both lena­lido­mide and bor­tez­o­mib have failed, who have received at least two prior treat­ment regi­mens and have dem­onstrated dis­ease pro­gres­sion on their last regi­men. Until POMALYST, there have been few options for patients whose dis­ease has progressed despite being treated with traditional ther­a­pies. Treatment with POMALYST has been shown to im­prove rates of over­all survival and extend pro­gres­sion-free survival in patients who no longer respond to lena­lido­mide or bor­tez­o­mib.¹

POMALYST received priority review status by Health Canada due to the high unmet medical need that exists and the clin­i­cal value that the treat­ment brings to patients and physicians.

"The approval of POMALYST is excellent news for the multiple myeloma com­munity. Until now there have been no approved options for patients whose dis­ease has progressed despite avail­able treat­ments," said Dr. Donna E. Reece, a leading multiple-myeloma-treating hematologist and researcher in Toronto. "With POMALYST, we have a new option that extends periods of remission, is generally well-tolerated and can be taken in the convenience of a patient's home."

The Health Canada approval of POMALYST was based on the MM-003 pivotal study, which was published in The Lancet Oncology in Octo­ber 2013. A total of 455 patients were enrolled in this Phase III, multi-centre, ran­dom­ized, open-label study. Patients in the study had received a median of five prior lines of ther­apy. Median over­all survival was sig­nif­i­cantly im­proved for the poma­lido­mide plus low-dose dexa­meth­a­sone arm, com­pared with the high-dose dexa­meth­a­sone only arm (12.7 months versus 8.1 months).² The MM-003 pivotal study also dem­onstrated sig­nif­i­cantly im­proved median pro­gres­sion-free survival of four months (p < 0.001) for patients with re­lapsed refractory multiple myeloma who were treated with poma­lido­mide plus low-dose dexa­meth­a­sone, com­pared with 1.9 months for those treated with high-dose dexa­meth­a­sone only.³

Treatment with POMALYST has been generally well-tolerated.⁴ The most commonly reported Grade 3 or 4 adverse reac­tions outlined in the MM-003 study in­cluded: anemia (27 per cent), neu­tro­penia (42 per cent) and thrombo­cytopenia (21 per cent). Other Grade 3 or 4 adverse events reported in this trial were pre­domi­nately: pneu­monia (9 per cent), fatigue (5 per cent), pyrexia (3 per cent) and periph­eral edema (1 per cent).⁵

"Since the year 2000, life ex­pec­tancy of multiple myeloma patients has almost doubled thanks to research and the devel­op­ment of new treat­ments," said Aldo E. Del Col, Co-founder and Chief Scientific Advisor for Myeloma Canada. "The approval of POMALYST marks another im­por­tant mile­stone for Canadian patients and brings us one step closer to transforming multiple myeloma into a long-term, man­ageable dis­ease."

POMALYST is ex­pec­ted to be commercially avail­able in March 2014.

About Multiple Myeloma

Multiple myeloma is a blood cancer of the plasma cells. Plasma cells are found in the bone marrow, which is the tissue that lies in the hollow interior of bones that produces new blood cells. The word "multiple" is often used because the malignant cells usually affect multiple areas of the bone marrow.

At least 7,000 Canadians are cur­rently living with multiple myeloma.⁶ Multiple myeloma is the second most common blood cancer after non-Hodgkin lym­phoma and rep­re­sents one per cent of all cancers and two per cent of all cancer deaths.⁷ In 2013, it was esti­mated that 2,500 people were diag­nosed with multiple myeloma and 1,350 people died from the dis­ease in Canada.⁸

About POMALYST™

POMALYST™ (poma­lido­mide capsules) is an oral immuno­modu­la­tory drug. Through its targeted action on treat­ment-resistant myeloma cells, POMALYST inhibits tumour cell growth, triggers cell death and en­hances the body's own immune response to the tumour. POMALYST was discovered and devel­oped by Celgene, and rep­re­sents the third novel oral treat­ment for multiple myeloma to be approved in Canada.

About RevAid®

POMALYST will be distributed through an existing controlled distribution pro­gram called RevAid®. This risk man­agement pro­gram was devel­oped in 2008 and will now in­clude POMALYST. The RevAid pro­gram is designed to prevent fetal exposure to POMALYST, due to its structural similarities to thalido­mide, a known human teratogen. Under the pro­gram, only prescribers and pharmacists registered with RevAid are able to prescribe and dispense POMALYST. In addi­tion, only those patients who are registered and meet all of the con­di­tions of the RevAid pro­gram will receive POMALYST.

About Celgene

Celgene Corpo­ra­tion is an integrated global bio­pharma­ceu­tical com­pany engaged primarily in the discovery, devel­op­ment and com­mer­cial­iza­tion of novel ther­a­pies for the treat­ment of cancer and inflammatory dis­eases through gene and protein reg­u­la­tion. For more in­­for­ma­tion, please visit the com­pany's website at www.celgene.com.

POMALYST is a trademark of Celgene Corpo­ra­tion.

References

1. San Miguel J, Weisel K, Moreau P, Lacy M, Song K, Delforge M, Karlin L, Goldschmidt H, Banos A, Oriol A, Alegre A, Chen C, Cavo M, Garderet L, Ivanova V, Martinez-Lopez J, Belch A, Palumbo A, Schey S, Sonneveld P, Yu X, Sternas L, Jacques C, Zaki M, and Dimopoulos M. Pomalidomide plus low-dose dexa­meth­a­sone versus high-dose dexa­meth­a­sone alone for patients with re­lapsed and refractory multiple myeloma (MM-003): A ran­domised, open-label, phase 3 trial. Lancet Oncol. October 2013; vol 14:1055-1066.
2. Ibid
3. Ibid
4. Ibid
5. Pomalyst™ Product Monograph. Celgene Corpo­ra­tion (2014)
6. About myeloma: Incidence and prev­a­lence in Canada [Internet]. Kirkland (QC): Myeloma Canada; 2013 [cited 2014 January 13]. http://www.myeloma.ca/en/incidence_prevalence.htm
7. About myeloma [Internet]. Kirkland (QC): Myeloma Canada; 2013 [cited 2014 January 13]. Available from: http://www.myeloma.ca/en/aboutmyeloma.htm
8. Multiple Myeloma Statistics [Internet]. Toronto (ON): Canadian Cancer Society; 2013 [cited 2014 January 13]. Available from: http://www.cancer.ca/en/cancer-information/cancer-type/multiple-myeloma/statistics/?region=on#ixzz2nxd169c0

Source: Celgene Corpo­ra­tion.