Tuesday, August 25, 2009

Amgen Announces Top-Line Results of Trial to Reduce Cardiovascular Events With Aranesp(R) Therapy (TREAT) in CKD Patients With Type 2 Diabetes

No Statistically Significant Difference in Cardiovascular and Renal Composite Endpoints Between Aranesp and Placebo

THOUSAND OAKS, Calif.—Aug. 25—Amgen (Nasdaq: AMGN) today announced that in a large, randomized, double-blind, placebo-controlled, Phase 3 study of patients with chronic kidney disease (CKD) (not requiring dialysis), anemia and type 2 diabetes (the Trial to Reduce Cardiovascular Endpoints with Aranesp((R)) Therapy, or TREAT), treatment of anemia with Aranesp(R) (darbepoetin alfa) to a hemoglobin target of 13 g/dL had no statistically significant effect on either of two primary endpoints compared with placebo treatment.

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Monday, August 17, 2009

Vectibix(R) Significantly Improved Progression-Free Survival in Second-Line Treatment of KRAS Wild-Type Metastatic Colorectal Cancer

Second Prospective Phase 3 Vectibix Combination Chemotherapy Trial to Show Progression-Free Survival Advantage in KRAS Wild-Type Population

THOUSAND OAKS, Calif. – Aug. 17 – Amgen (Nasdaq: AMGN) today announced positive top-line results from a Phase 3 trial evaluating Vectibix (panitumumab) in combination with FOLFIRI (an irinotecan-based chemotherapy) as a second-line treatment in 1,186 patients with metastatic colorectal cancer (mCRC). The co-primary endpoints, tested independently, were progression-free and overall survival.

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Thursday, August 06, 2009

Vectibix(R) in Combination With Chemotherapy Significantly Improved Progression-Free Survival in First-Line Metastatic Colorectal Cancer

Pivotal Study Meets Primary Endpoint of Progression-Free Survival in Wild-Type KRAS Population

Phase 3 Results Reinforce Importance of KRAS Testing

THOUSAND OAKS, Calif. – Aug. 6 – Amgen (Nasdaq: AMGN) today announced that Vectibix (panitumumab), administered in combination with FOLFOX (an oxaliplatin-based chemotherapy), significantly prolonged progression-free survival (PFS) compared with FOLFOX alone in the first-line treatment of patients with KRAS wild-type metastatic colorectal cancer (mCRC).

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Friday, July 17, 2009

Amgen Announces KRAS Safety Update to U.S. Prescribing Information for Vectibix(R) (Panitumumab)

Class Labeling Recognizes KRAS as a Predictive Biomarker for anti-EGFr Antibody Monotherapy in Metastatic Colorectal Cancer

Results from First Pivotal Trials Prospectively Evaluating KRAS Utility in Combination Therapy Expected In Third Quarter 2009

 THOUSAND OAKS, Calif., July 17 /PRNewswire-FirstCall/—Amgen Inc. (Nasdaq: AMGN) today announced the U.S. Food and Drug Administration (FDA) has approved revisions to the U.S. prescribing information for the epidermal growth factor receptor (EGFr) class of antibodies, including Vectibix (panitumumab). This decision follows the FDA’s December 2008 Oncologics Drugs Advisory Committee (ODAC) meeting where the clinical utility of the KRAS gene as a predictive biomarker in patients with metastatic colorectal cancer (mCRC) treated with anti-EGFr antibody was discussed.

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Monday, June 08, 2009

New Study Shows Nplate(R) Significantly Reduces Splenectomy Rate and Treatment Failure in Patients With Chronic ITP

BERLIN – June 7 – Amgen Inc. (Nasdaq: AMGN) today released the results of a new study comparing Nplate(R) (romiplostim) to the medical standard of care (SOC) in non-splenectomised adult patients with chronic immune thrombocytopenic purpura (ITP). Chronic ITP is a serious autoimmune disorder characterised by low platelet counts in the blood (thrombocytopenia), which can lead to serious bleeding events. The study results show Nplate significantly reduced the incidences of splenectomy and treatment failures in non-splenectomised adult patients with chronic ITP when compared to medical SOC. The results were presented today as an oral presentation at the 14th congress of the European Hematology Association (EHA abstract #1672).

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