Articles tagged with: Immunomodulatory Agents

Press Releases»

[ by | Dec 19, 2014 8:10 am | Comments Off ]
Celgene Receives Positive CHMP Opinion To Extend Revlimid (Lenalidomide) For Continuous Use In Patients With Newly Diagnosed Multiple Myeloma And Ineligible For Transplant

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 continuous oral treat­ment with REVLIMID® in adult patients with pre­vi­ously untreated multiple myeloma who are not eli­gible for stem cell trans­plan­ta­tion.

The CHMP reviews appli­ca­tions for all 28 member states in the European Union (EU), as well as Norway, Liechtenstein and Iceland. The European Com­mis­sion, which generally follows the recom­men­da­tion of the CHMP, is ex­pec­ted to make its final de­ci­sion in approx­i­mately …

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[ by | Feb 11, 2014 6:30 am | Comments Off ]

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

Health Canada Approves Pomalyst (Pomalidomide Capsules) Providing New Hope For Patients With Progressive Multiple Myeloma 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 …

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[ by | Nov 28, 2013 5:00 pm | Comments Off ]

Boston (Press Release) - Despite its tragic legacy of causing birth defects 50 years ago, thalido­mide – and newer drugs derived from it – has been reborn as an effective treat­ment for multiple myeloma and other cancers. How they act to slow cancer's spread, how­ever, has long defied explanation.

In a new report, scientists at Dana-Farber Cancer Institute say they have discovered that the drugs kill multiple myeloma cells by a mech­a­nism that's dif­fer­en­t from the way that they cause birth defects.

As a result, "It may be possible to develop better …

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[ by | Nov 7, 2013 9:02 am | Comments Off ]

Study is one of more than 160 abstracts eval­u­ating 10 Celgene com­­pounds across a range of blood cancers

Initial Phase III Results Of The FIRST Trial (MM-020/​IFM 07 01) In Newly Diagnosed Multiple Myeloma (NDMM) Patients (PTS) Ineligible For Stem Cell Trans­plan­tation (SCT) Accepted For Plenary Presentation At ASH Annual Meeting Boudry, Switzerland (Press Release) - Celgene Inter­na­tional Sàrl, a wholly-owned sub­sid­i­ary of Celgene Corpo­ra­tion (NASDAQ:CELG) today announced that data from FIRST® (Frontline Investigation of Lena­lido­mide + Dexa­meth­a­sone Versus Standard Thalido­mide), its phase III study (MM-020/IFM 07-01) of REV­LI­MID® (lena­lido­mide) in com­bi­na­tion with dex­a­meth­a­sone in patients newly diag­nosed with multiple myeloma (NDMM) in­eli­gible for stem cell trans­plant will be presented on Sunday, Dec. 8 during the plenary session of the 55thAmerican Society of Hematology annual meeting in New Orleans, La.

Abstracts for the meeting were released today on the society’s …

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[ by | Sep 5, 2013 7:30 am | Comments Off ]

Poma­lido­mide plus low-dose dexa­metha­sone dem­onstrated sig­nif­i­cantly longer median pro­gres­sion-free survival and over­all survival at a median follow-up of 10 months

Results From Phase III Study (MM-003) Of Poma­lido­mide Plus Low-Dose Dexa­metha­sone Versus High-Dose Dexa­metha­sone In Relapsed And Refractory Multiple Myeloma Patients Published In The Lancet Oncology Boudry, Switzerland (Press Release) - Celgene Inter­na­tional Sàrl, a wholly-owned sub­sid­i­ary of Celgene Corpo­ra­tion (NASDAQ:CELG), today announced that updated results from MM-003, a phase III multi-center, ran­dom­ized open-label study (n=455) of poma­lido­mide (marketed as POMALYST® in the U.S. and IMNOVID® in the E.U.) plus low-dose dexa­metha­sone, were published online ahead of print in The Lancet Oncology.

The study compared oral poma­lido­mide plus low-dose dexa­metha­sone with high-dose dexa­metha­sone in patients with refractory or re­lapsed and refractory multiple myeloma who have failed at least two prior thera­pies with both bor­tez­o­mib and lena­lido­mide, ad­min­is­tered alone or in …

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[ by | Aug 9, 2013 2:00 am | Comments Off ]
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

Boudry, Switzerland (Press Release) - Celgene Inter­na­tional Sàrl, a wholly-owned sub­sid­i­ary of Celgene Corpo­ra­tion (NASDAQ: CELG) today 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 …

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[ by | Aug 1, 2013 7:30 am | Comments Off ]
Study Of Revlimid (Lenalidomide) In Patients With High-Risk Asymptomatic Smoldering Multiple Myeloma Published In New England Journal of Medicine

Boudry, Switzerland (Press Release) - Celgene Inter­na­tional Sàrl, a wholly-owned sub­sid­i­ary of Celgene Corpo­ra­tion (NASDAQ: CELG), today announced that data eval­u­ating treat­ment with REVLIMID® (lena­lido­mide) in com­bi­na­tion with dexa­meth­a­sone followed by REVLIMID main­te­nance ther­apy in patients with high-risk asymptomatic smol­der­ing multiple myeloma were published in the August 1 edition of The New Eng­land Journal of Medicine. Smoldering multiple myeloma is an early, asymptomatic form of the disease char­ac­ter­ized by a 10% per year risk of pro­gres­sion to symp­tomatic disease over the first five years.

The Phase III, ran­dom­ized, multi­center, open-label study, led by Maria-Victoria Mateos, …

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