Articles tagged with: Lenalidomide

Press Releases»

[ by | Apr 23, 2019 8:00 am | Comments Off ]
ChemioCare Announces Initiation Of PETT Based (Permeation Enhanced Transdermal Technology) Lenalidomide Program

New York, NY (Press Release) – ChemioCare USA Inc. (“ChemioCare” or the “Company”), a plat­form com­pany focused on pro­pri­e­tary trans­dermal delivery, announced today the Company is initiating devel­op­ment of a trans­dermal for­mu­la­tion of lena­lido­mide, which is cur­rently marketed in an oral form. ChemioCare believes that by applying its permeation en­hanced trans­dermal tech­nology (PETT), it can poten­tially target and deliver the optimal con­tin­uous lena­lido­mide AUC (drug level area under the curve) that may lead to reduced drug toxicity and im­prove­ment in the over­all safety profile of the drug. These im­prove­ments can be ex­pec­ted to …

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Press Releases»

[ by | Mar 29, 2019 8:12 am | Comments Off ]

The CHMP adopted two pos­i­tive opinions recommending European Com­mis­sion approval of:

  • REVLIMID in com­bi­na­tion with bor­tez­o­mib and dexa­meth­a­sone (RVd) in adult patients with pre­vi­ously untreated multiple myeloma who are not eli­gible for trans­plant
  • IMNOVID in com­bi­na­tion with bor­tez­o­mib and dexa­meth­a­sone (PVd), for adult patients with multiple myeloma, who have received at least one prior treat­ment regi­men in­­clud­ing lena­lido­mide

Celgene Receives CHMP Positive Opinions For Both Revlimid (Lenalidomide) And Imnovid (Pomalidomide)-Based Triplet Combination Regimens For Patients With Multiple Myeloma Summit, NJ (Press Release) – Celgene Corpo­ra­tion (NASDAQ:CELG), today announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted pos­i­tive opinions for two triplet regi­mens based on Celgene’s pro­pri­e­tary IMiD® medications, REVLIMID (lena­lido­mide) and IMNOVID (poma­lido­mide).

The CHMP recommended approval of an expanded indi­ca­tion of REVLIMID as com­bi­na­tion ther­apy with bor­tez­o­mib and dexa­meth­a­sone (RVd) for the treat­ment of adult patients with pre­vi­ously untreated multiple myeloma who are not eli­gible for trans­plant.

The committee also recommended approval …

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Press Releases»

[ by | Oct 23, 2018 4:30 pm | Comments Off ]
Revlimid (Lenalidomide) Demonstrated A Significant Improvement In Progression-Free Survival (PFS) Compared With Observation In A Randomized Study In Patients With Smoldering Multiple Myeloma

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. …

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Opinion»

[ by | Oct 28, 2017 5:33 pm | 16 Comments ]
Living For Lamingtons: Let's Talk Maintenance

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 …

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Press Releases»

[ by | Feb 24, 2017 5:43 am | Comments Off ]
  • 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

Revlimid (Lenalidomide) Approved By The European Commission As Monotherapy For The Maintenance Treatment Of Patients With Newly Diagnosed Multiple Myeloma After Autologous Stem Cell Transplantation 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 …

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Press Releases»

[ by | Feb 22, 2017 4:02 pm | Comments Off ]
  • 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

FDA Expands Indication For Revlimid (Lenalidomide) As A Maintenance Treatment For Patients With Multiple Myeloma Following Autologous Hematopoietic Stem Cell Transplant (Auto-HSCT) 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 …

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Opinion»

[ by | Feb 16, 2017 4:12 pm | 25 Comments ]
Mohr’s Myeloma Musings: Change Of Game Plan

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 …

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