Toronto, Canada (Press Release) – Celgene Inc. announced today that Health Canada has expanded the indi­ca­tion for REVLIMID® (lena­lido­mide capsules), in multiple myeloma. REVLIMID® in com­bi­na­tion with dexa­meth­a­sone, is indicated for the treat­ment of multiple myeloma patients who are not eli­gible for stem cell trans­plant.¹ Nearly 60 per cent of newly diag­nosed people living with multiple myeloma are not eli­gible for a stem cell trans­plant,² so the expanded indi­ca­tion provides a new option for this patient pop­u­la­tion, where few existed before.

"The expanded indi­ca­tion of REVLIMID® provides patients with a treat­ment much earlier in their disease, and offers this patient pop­u­la­tion an all-oral, mel­phalan-free option, for a disease that con­tinues to be dif­fi­cult to treat," said Dr. Donna Reece, Asso­ci­ate Pro­fessor of Medicine, Director, Program for Multiple Myeloma and Related Diseases, Princess Margaret Hospital. "We have witnessed the benefits that REVLIMID® has provided patients over the years as an effective and convenient oral medication for relapsing disease. With this new clin­i­cal evi­dence, we know that keeping newly diag­nosed multiple myeloma patients on REVLIMID® may help delay disease pro­gres­sion and reduce the risk of death. As such, we are looking forward to having REVLIMID® as a key option in the first-line setting for the appro­pri­ate patients."

The indi­ca­tion was expanded based on safety and efficacy results from the phase 3 study, FIRST trial, which eval­u­ated continuous REVLIMID® in com­bi­na­tion with dexa­meth­a­sone until disease pro­gres­sion versus mel­phalan, pred­ni­sone and thalido­mide (MPT) for 18 months as the pri­mary analysis.³ Just over 1,600 newly diag­nosed patients who were not can­di­dates for stem cell trans­plant were studied, in­­clud­ing 23 clin­i­cal trials sites and 251 patients in Canada, the second highest enrolling country in the world.⁴ The median age of trial par­tic­i­pants was 73 years old.⁵

"Patients who have been newly diag­nosed with multiple myeloma, but who are not eli­gible for a stem cell trans­plant, now have the option of REVLIMID®, a convenient once-daily treat­ment that was pre­vi­ously only avail­able to patients who had re­lapsed disease," said Aldo Del Col, Co-Founder and Chairman, Myeloma Canada. "I'm pleased to see that some provinces and territories, in­­clud­ing Alberta, Saskatchewan, Nova Scotia, the Yukon Territory, New Brunswick and Newfoundland and Labrador, have already in­cluded REVLIMID® on their formularies in the first-line setting for these patients, and antic­i­pate that other provinces and territories will soon provide access to patients who may benefit from this treat­ment."

About Multiple Myeloma

Myeloma is the third most common blood cancer after lym­phoma and leukemia.⁶ It is esti­mated that 2,700 Canadians were diag­nosed with multiple myeloma in 2016,⁷ and the majority of patients will not be eli­gible for trans­plant.⁸ Approximately 1,600 men and 1,150 women were diag­nosed with multiple myeloma in Canada in 2016.⁹ Innovations in treat­ment have in­­creased the average life ex­pec­tancy of a myeloma patient, with many living 10 years or longer.¹⁰

About the FIRST Trial

In this ran­domized, open-label, three-arm trial, median pro­gres­sion-free survival, the length of time a patient lives from study ran­domization to disease pro­gres­sion or death, was the pri­mary end­point of the study. Progression-free survival was sig­nif­i­cantly longer for patients receiving REVLIMID® Continuous (25.5 months) than for those treated with MPT (21.2 months; HR=0.72; p=0.0001). Median over­all survival in the two groups was 58.9 months and 48.5 months, re­spec­tive­ly (HR 0.75; 95% CI 0.62, 0.90), based on a March 3, 2014 interim over­all survival analysis.¹¹ Patients in the REVLIMID® Continuous arm had a 25 per cent reduction in the risk of death compared to patients in the MPT arm (HR=0.75).¹²

The most common adverse events reported in the REVLIMID® arm given until disease pro­gres­sion in­cluded diarrhea, anemia, con­sti­pa­tion, periph­eral edema, neu­tro­penia, fatigue, back pain, nausea, asthenia and insomnia.¹³

About REVLIMID®

In Canada, REVLIMID® is already indicated for the treat­ment of patients with trans­fusion-dependent anemia due to Low- or Intermediate-1-risk myelo­dys­plastic syn­dromes asso­ci­ated with a deletion 5q cyto­genetic ab­nor­mal­ity with or without addi­tional cyto­genetic ab­nor­malities. Approval for this indi­ca­tion is based on red blood cell transfusion independence response rates. Now, REVLIMID® in com­bi­na­tion with dexa­metha­sone, is indicated for the treat­ment of multiple myeloma patients who are not eli­gible for stem cell trans­plant.¹⁴

About Celgene Corpo­ra­tion

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.celgenecanada.net.

Indication and Clinical Use:

REVLIMID® (lena­lido­mide capsules) in com­bi­na­tion with dexa­meth­a­sone is indicated for the treat­ment of multiple myeloma patients who are not eli­gible for stem cell trans­plant.¹⁵

Geriatric Patients (>65 years of age): In presence of renal im­pair­ment, starting dose ad­just­ments and monitoring of renal function throughout treat­ment are recommended.

Limitation of Use: REVLIMID® is not indicated and is not recommended for the treat­ment of patients with chronic lym­pho­cytic leukemia (CLL) outside of controlled clin­i­cal trials.

Contraindications:

• Pregnant women and women at risk of becoming pregnant
• Breastfeeding women
• Male patients unable to follow or comply with the required contraceptive measures

Serious Warnings and Precautions:

REVLIMID® should be admin­istered under the supervision of a qualified physician ex­peri­enced in the use of cancer chemo­thera­peutic agents.

• Pregnancy: Potential for human birth defects, stillbirths, and spontaneous abortions
• Hematologic: Neutropenia and thrombocytopenia
• Venous and arterial thromboembolism: Deep vein thrombosis (DVT), pul­monary em­bolism (PE), myo­cardial in­farction (MI) and cerebro­vascular events. Anti­thrombotic pro­phylaxis recom­mended.
• Hepatic: Hepatotoxicity including fatal cases.

REVLIMID® is only avail­able through a controlled distribution pro­gram called RevAid®.

Other Relevant Warnings and Precautions:

• Patients should not donate blood or semen
• Consideration should be given to the dose of dexamethasone used
• Cardiovascular disorders
• Second primary malignancies (SPM)
• Hematologic toxicities
• Hepatotoxicity
• Immune reactions: angioedema, Stevens-Johnson syndrome, toxic epidermal necrolysis and graft versus host disease
• Increased mortality in patients with chronic lymphocytic leukemia (CLL)
• Dosage adjustment in moderate or severe renal impairment
• Tumour lysis syndrome in patients with CLL, MM, and non-Hodgkins Lymphoma. Some cases fatal.
• Tumor Flare Reaction in patients with CLL and mantle cell lymphoma (MCL)
• Monitoring and Laboratory testing required
• Lactose/glucose intolerance

For More Information:

Please consult the Product Monograph at www.revlimidpm.ca for im­por­tant in­­for­ma­tion relating to adverse reac­tions, drug inter­actions, and dosing in­­for­ma­tion. The Product Monograph is also avail­able by calling 1-877-923-5436.

References

1. REVLIMID® Product Monograph, December 9, 2016.
2. Celgene Data on File.
3. REVLIMID® Product Monograph, December 9, 2016.
4. REVLIMID® Product Monograph, December 9, 2016.
5. REVLIMID® Product Monograph, December 9, 2016.
6. Leukemia and Lymphoma Society of Canada. http://www.llscanada.org/sites/default/files/National/CANADA/Pdf/Blood%20Cancer%20Facts%202014.pdf. Accessed January 6, 2017.
7. Canadian Cancer Society. http://www.cancer.ca/en/cancer-information/cancer-type/multiple-myeloma/statistics/?region=on. Accessed January 6, 2017.
8. Celgene Data on File.
9. Canadian Cancer Society. http://www.cancer.ca/en/cancer-information/cancer-type/multiple-myeloma/statistics/?region=on. Accessed January 6, 2017.
10. About Myeloma. (2016). Myeloma Canada 2016. http://www.myelomacanada.ca/en/aboutmyeloma.htm. Accessed January 6, 2017.
11. REVLIMID® Product Monograph, December 9, 2016.
12. REVLIMID® Product Monograph, December 9, 2016.
13. REVLIMID® Product Monograph, December 9, 2016.
14. REVLIMID® Product Monograph, December 9, 2016.
15. REVLIMID® Product Monograph, December 9, 2016.

Source: Celgene Inc.