Sunday, June 06, 2010

New AMG 386 Data Demonstrate Promising Antitumor Activity in Patients With Recurrent Ovarian Cancer

AMG 386 Treatment Response Increased With Dose And Exposure

AMG 386 Moving Into Phase 3 For Recurrent Ovarian Cancer

Separately, Two Analyses Provide Evidence Of Biomarker As Predictor Of Tumor Response To Motesanib

THOUSAND OAKS, Calif., June 6, 2010 /PRNewswire via COMTEX/ --Amgen (Nasdaq: AMGN) today announced that AMG 386, combined with paclitaxel, demonstrated antitumor activity in a randomized Phase 2 trial involving 161 patients with recurrent ovarian cancer.  The results are being presented for the first time in an oral presentation at the 2010 American Society of Clinical Oncology (ASCO) Annual Meeting. (Abstract Number: 5000)

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Posted in Press Releases, Pipeline News

Saturday, June 05, 2010

Denosumab Demonstrated Superiority Over Zometa(R) in Delay of Complications Due to Bone Metastases in Advanced Prostate Cancer

The Third Of Three Pivotal Head-To-Head Trials Submitted To FDA For Treatment Of Patients With Bone Metastases

THOUSAND OAKS, Calif., June 5, 2010 /PRNewswire via COMTEX/ --Amgen (Nasdaq: AMGN) today announced detailed results from a Phase 3, head-to-head trial which compared the efficacy and safety of denosumab versus Zometa(R) (zoledronic acid) in 1,901 patients with hormone-refractory prostate cancer and bone metastases. The study met its primary and secondary endpoints and demonstrated denosumab’s superiority over Zometa in delaying or preventing skeletal related events (SREs). These statistically significant results will be presented in an oral session on June 6, 2010 at the American Society of Clinical Oncology (ASCO) 2010 Annual Meeting in Chicago (Late Breaking Abstract Number #LBA4507).

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Posted in Press Releases, Pipeline News

Saturday, June 05, 2010

New Analyses of Denosumab Pivotal Phase 3 Trials Reinforce Potential Advantages Over Standard of Care

Integrated Analysis Shows Denosumab Superiority Over Zometa(R) In Delaying Or Preventing Skeletal Related Events In Broad Population With Advanced Cancer

Additional Analyses Demonstrate Denosumab Significantly Delays Onset And Worsening Of Bone Pain Over Zometa

Exploratory Analysis Shows Denosumab Superior To Zometa In Delaying Time To First Skeletal Related Event Or Hypercalcemia Of Malignancy

THOUSAND OAKS, Calif., June 5, 2010 /PRNewswire via COMTEX/—Amgen (Nasdaq: AMGN) today announced positive results from several new analyses of two Phase 3 trials studying denosumab compared with Zometa(R) (zoledronic acid), the current standard of care, for the treatment of bone metastases in patients with advanced breast cancer ("136 study") and solid tumors or multiple myeloma ("244 study").  Results from these trials reinforce denosumab’s consistent ability to delay the complications of bone metastases in patients with advanced cancer.  These results are being presented during the 2010 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago.

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Tuesday, February 09, 2010

Denosumab Study Published in The Lancet Oncology Demonstrated 86 Percent Tumor Reduction for Patients with Giant Cell Tumor of the Bone

THOUSAND OAKS, Calif. (February 9, 2010) – Amgen (NASDAQ: AMGN) issued the following statement on the publication of results online today by the Lancet Oncology. For a summary of the manuscript click here.

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Posted in Pipeline News

Monday, October 19, 2009

Amgen Provides Update on Status of Prolia(TM) (Denosumab) Biologics License Application (BLA) Submitted to the U.S. Food and Drug Administration (FDA)

THOUSAND OAKS, Calif. – Oct 19, 2009 – Amgen Inc. (Nasdaq: AMGN) today announced that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter for the Biologic License Applications (BLA) for Prolia(TM) (denosumab) in the treatment and prevention of postmenopausal osteoporosis. The FDA issues Complete Response Letters to request additional information needed to complete the review of applications for product approval. 

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Posted in Press Releases, Pipeline News