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 …
Decision could significantly improve transplant outcomes for patients with multiple myeloma
Beerse, Belgium (Press Release) - Janssen-Cilag International NV (Janssen) announced today that the European Commission (EC) has approved the use of VELCADE® (bortezomib) as induction therapy (a first therapeutic option) in combination with dexamethasone (VD) or thalidomide and dexamethasone (VTD).[1] This licence extension will apply to adult patients with previously-untreated multiple myeloma who are eligible for high-dose chemotherapy with haematological stem cell transplantation.
Until now, VELCADE’s (bortezomib) indication has been limited to its use, in combination with melphalan and prednisone, in adult patients with multiple myeloma that are previously untreated and ineligible for stem …
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, …
Boulder, CO (Press Release) - Array BioPharma Inc. (NASDAQ: ARRY) announced a strategic collaboration with Celgene Corporation for an Array-invented preclinical development program targeting a novel inflammation pathway. Under the terms of the agreement Array will receive an up-front payment of $11 million and Celgene will have an exclusive option to license multiple clinical development candidates. Array is entitled to receive potential milestone payments of up to $376 million based upon achieving certain development, regulatory and sales objectives. Array is also entitled to receive royalties on net sales of all drugs and will retain all rights …
Strategic Collaboration Includes Option for Celgene to Acquire Acetylon
Boston, MA (Press Release) - Acetylon Pharmaceuticals, Inc., the leader in development of selective histone deacetylase (HDAC) inhibitors for enhanced therapeutic outcomes (the “Company”), today announced a strategic collaboration and option agreement with Celgene Corporation (NASDAQ: CELG), which supports the development of Acetylon’s portfolio of oral, selective HDAC inhibitors in oncology, hematology, immunology, and neurologic disease indications. The agreement includes an exclusive option for the future acquisition of Acetylon by Celgene.
The collaboration will focus on the continued clinical advancement of Acetylon’s lead …
The update will result in improved patient prognoses, better informed patient care decisions and reduced costs.
New York, NY and Little Rock, AR (Press Release) - Signal Genetics today announced that it has launched an update to its MyPRS gene expression assay for patients with Multiple Myeloma, which will improve patient prognoses, enable better informed patient care decisions, and ultimately reduce costs.
Every MyPRS test performed now includes an analysis of an additional set of 813-genes within the patient’s genome, which is used to create an individualized ‘Virtual Karyotype’ view of the …
Summit, NJ (Press Release) - Celgene Corporation (NASDAQ: CELG) today announced that after consultation with the U.S. Food and Drug Administration (FDA) Celgene will discontinue treatment with REVLIMID® (lenalidomide) in the open-label, phase III ORIGIN® trial, which enrolled 450 patients in over 100 sites in 26 countries. An imbalance was observed in the number of deaths in patients treated with lenalidomide versus patients treated with chlorambucil.
The FDA placed the ORIGIN study on clinical hold on July 12, 2013, with the discontinuation of lenalidomide treatment. All clinical investigators in ongoing chronic lymphocytic leukemia studies using lenalidomide will be officially …