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Nektar Announces that FDA Grants Fast Track Designation to Etirinotecan Pegol (NKTR-102) for the Treatment of Metastatic Breast Cancer
Date:11/7/2012

cerMore than one million people worldwide are diagnosed with breast cancer globally every year. (1)  The chance of developing invasive breast cancer at some time in a woman's life is a little less than one in eight (12%).  There are approximately 200,000 new cases of breast cancer in the United States and 430,000 in Europe each year. (2)  Metastatic breast cancer refers to cancer that has spread from the breast to distant sites in the body. 

Anthracyclines and taxanes (AT) are the most active and widely used chemotherapeutic agents for breast cancer, but the increased use of these agents at an early stage of disease often renders tumors resistant to these drugs by the time the disease recurs, thereby reducing the number of treatment options for metastatic disease. Drugs used to treat patients who progress following AT treatment can have response rates of 20-30%; however, resistance develops rapidly and new agents with different mechanisms of action, such as topoisomerase I inhibitors, are needed that have the potential to overcome the problem of drug resistance to prior therapies. (3)  There are currently no FDA-approved topoisomerase I inhibitors to treat breast cancer.

About NektarNektar Therapeutics is a biopharmaceutical company developing novel therapeutics based on its PEGylation and advanced polymer conjugation technology platforms. Nektar has a robust R&D pipeline of potentially high-value therapeutics in oncology, pain and other therapeutic areas. In the area of pain, Nektar has an exclusive worldwide license agreement with AstraZeneca for naloxegol (NKTR-118), an investigational drug candidate, which is being evaluated in Phase 3 clinical studies as a once-daily, oral tablet for the treatment of opioid-induced constipation.  This agreement also includes NKTR-119, an earlier stage development program that is a co-formulation of naloxegol and an opioid.  NKTR-181, a novel mu-opioid analgesic can
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1. Nektar to Announce Financial Results for the Third Quarter of 2012 On Tuesday, November 13, 2012, After Close of U.S.-Based Financial Markets
2. Nektar Therapeutics President and CEO, Howard W. Robin, To Present at the UBS 2012 Global Life Sciences Conference in New York City
3. Nektar Therapeutics Reports Financial Results for the Second Quarter of 2012
4. Nektar Announces Initiation of Investigator-Sponsored Trial Evaluating Etirinotecan Pegol (NKTR-102) in Patients with Bevacizumab (Avastin)-resistant High-Grade Glioma
5. Nektar Announces Start of Enrollment in Phase 2 Study of NKTR-181, a Novel Opioid Analgesic Molecule, for Treatment of Chronic Pain
6. Nektar Announces that FDA Grants Fast Track Designation to NKTR-181, a New Oral Opioid Analgesic Molecule, for the Treatment of Moderate to Severe Chronic Pain
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