Summit, NJ (Press Release) – Celgene Corpo­ra­tion (NASDAQ: CELG) today announced results from an open-label phase II/III National Clinical Trials Network (NCTN) study led by the ECOG-ACRIN Cancer Research Group and sponsored by the National Cancer Institute (NCI), part of the National Institutes of Health. REVLIMID® (lena­lido­mide) was provided by Celgene under a clin­i­cal trials agree­ment with the NCI’s Division of Cancer Treatment and Diagnosis.

ECOG E3A06 is a ran­dom­ized study eval­u­ating the safety and efficacy of the inves­ti­ga­tional use of REVLIMID mono­therapy versus observation in patients with asymptomatic smol­der­ing multiple myeloma. …

Several months after I had my stem cell transplant, my doctor suggested that it would be a good idea to begin maintenance treatment with Rev­limid (lena­lido­mide). He believed that main­te­nance was likely to lead to longer pro­gres­sion-free survival. I remember him saying that, in his experience, main­te­nance therapy often put the myeloma into hiber­nation. That sounded good to me – long-term hiber­nation, I hope.

He also explained to my husband Graham and me that he thought that the main­te­nance therapy might lead to longer over­all survival. At the same time, he said that …

• Oral REVLIMID® is the first and only medicine licensed in Europe for use as post-autologous stem cell trans­plan­ta­tion main­te­nance ther­apy in multiple myeloma
• The new indi­ca­tion expands the avail­a­bil­ity of REVLIMID® across the disease con­tin­uum of multiple myeloma

Boudry, Switzerland (Press Release) – Celgene Inter­na­tional Sàrl, a wholly-owned sub­sid­i­ary of Celgene Corpo­ra­tion (NASDAQ: CELG), today announced that the European Com­mis­sion (EC) has approved REVLIMID® (lena­lido­mide) as mono­therapy for the main­te­nance treat­ment of adult patients with newly diag­nosed multiple myeloma who have undergone au­tol­o­gous stem cell trans­plan­ta­tion (ASCT). REVLIMID® is the first and only licensed main­te­nance treat­ment avail­able to these patients.

The REVLIMID® Marketing Authorisation has been updated to in­clude this new indi­ca­tion, which expands on the existing multiple myeloma indi­ca­tions as …

• REVLIMID is the first and only treat­ment approved for main­te­nance fol­low­ing auto-HSCT
• Updated data from two large, ran­domized, controlled studies dem­onstrated median pro­gres­sion-free survival (PFS) advantages of 3.8 and 1.9 years, re­spec­tive­ly, in favor of patients receiving REVLIMID compared to no main­te­nance
• Median over­all survival (OS) for patients receiving REVLIMID in each study was 9.3 years and 8.8 years, re­spec­tive­ly, compared to 7 and 7.3 years for no main­te­nance in a descriptive analysis (studies not powered for OS)
• Approval enables Celgene to provide patients with treat­ment options across the multiple myeloma spectrum

Summit, NJ (Press Release) – Celgene Corpo­ra­tion (NASDAQ:CELG) today announced that the U.S. Food and Drug Admin­istra­tion (FDA) has expanded the existing indi­ca­tion for REVLIMID (lena­lido­mide) 10 mg capsules to in­clude use for patients with multiple myeloma as main­te­nance ther­apy fol­low­ing au­tol­o­gous hema­to­poietic stem cell trans­plant (auto-HSCT). The expanded indi­ca­tion makes REVLIMID the first and only treat­ment to receive FDA approval for main­te­nance use fol­low­ing auto-HSCT.

“Autologous stem cell trans­plant after induction ther­apy is …

During my 25-year career as a boy’s head basketball coach, I found the most satisfying (and most important) part of coaching was planning and devising game plans. 

Putting my knowledge and experience to test to give my teams the best chance of winning was challenging and time consuming, but also enjoyable and exciting. Equally enjoyable and exciting was making adjustments to the game plan during the course of the game.

At times the game plan worked to perfection. Sometimes, the plan had to be adjusted immediately. With my better teams, the game plans varied …

• REVLIMID® is the first and only medicine granted positive CHMP opinion for post-Autologous Stem Cell Transplantation (ASCT) main­te­nance ther­apy in MM
• The new indi­ca­tion expands the avail­a­bil­ity of REVLIMID® across the disease con­tin­uum of MM

Boudry, Switzerland (Press Release) – Celgene Inter­na­tional Sàrl, a wholly owned sub­sid­i­ary of Celgene Corpo­ra­tion (NASDAQ:CELG), today announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for the use of REVLIMID® as mono­therapy for the main­te­nance treat­ment of adult patients with newly diag­nosed multiple myeloma (MM) who have undergone au­tol­o­gous stem cell trans­plan­ta­tion (ASCT). Once approved by the European Com­mis­sion, REVLIMID® will be the first and only licensed main­te­nance treat­ment avail­able to …

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 …