Data Suggest Treatment with ABRAXANE plus Gemcitabine Reduces Levels of CA19-9 and Increases the Frequency of PET Responses; Both Tools Found to be Potential Prognostic Factors of Overall Survival - 2013 ASCO Annual Meeting

BOUDRY, Switzerland - Saturday, June 8th 2013 [ME NewsWire]

(BUSINESS WIRE)-- Celgene International Sàrl, a subsidiary of Celgene Corporation (NASDAQ: CELG), announced several analyses of a phase III clinical trial of ABRAXANE® (paclitaxel protein-bound particles for injectable suspension) (albumin-bound) in combination with gemcitabine in previously untreated patients with advanced pancreatic cancer. The data were presented at the American Society of Clinical Oncology (ASCO) 2013 annual meeting in Chicago.

The MPACT (Metastatic Pancreatic Adenocarcinoma Clinical Trial) overall trial results demonstrated that patients treated with ABRAXANE plus gemcitabine had a statistically significant improvement in overall survival compared with those tr ... Read more »

SUMMIT, N.J. - Sunday, June 9th 2013 [BUSINESS WIRE/ ME NewsWire]

-- Celgene Corporation (NASDAQ: CELG) today announced the U.S. Food and Drug Administration (FDA) has approved the company’s supplemental new drug application (sNDA) for REVLIMID® (lenalidomide) for the treatment of patients with mantle cell lymphoma (MCL) whose disease has relapsed or progressed after two prior therapies, one of which included bortezomib.

"There remains a tremendous unmet need for patients with previously-treated mantle cell lymphoma,” said Andre Goy, M.D., M.S., Chairman and Director and Chief of Lymphoma, John Theurer Cancer Center at Hackensack UMC and Chief Science Officer and Director of Research and Innovation at Regional Cancer Care Associates, LLC. "The approval of lenalidomide delivers a new option, and the first oral therapy in this area of lymphoma.”

The approval was based on the results of MCL-001, a phase II, multi-center, single arm, open label study evaluating len ... Read more »