August 31, 2012
U.S. FDA Approves XTANDI(R) (enzalutamide) After Priority Review for Patients With
Metastatic Castration-Resistant Prostate Cancer Previously Treated With Docetaxel
Medivation to Host Conference Call Today at 11:45am PT
SAN FRANCISCO, CA and TOKYO -- (Marketwire) -- 08/31/12 -- Medivation, Inc. (NASDAQ: MDVN) and Astellas Pharma Inc. (TSE: 4503) today announced that the U.S. Food and Drug Administration (FDA) has granted approval to XTANDI® (enzalutamide) capsules for the treatment of patients with metastatic castration-resistant prostate cancer who have previously received docetaxel. XTANDI is an oral, once-daily androgen receptor inhibitor.
The FDA accepted the XTANDI New Drug Application (NDA) on July 23, 2012, and granted the filing Priority Review Designation with a Prescription Drug User Fee Act (PDUFA) action date of November 22, 2012. Medivation and Astellas expect to make XTANDI available to patients in the United States in mid-September 2012, and the specific availability date will be announced on www.XtandiHCP.com as soon as it is known. Separately, a Marketing Authorization Application for XTANDI has been accepted for review by the European Medicines Agency (EMA).
For Immediate Release: Sept. 12, 2012
Media Inquiries: Stephanie Yao, 301-796-0394, firstname.lastname@example.org
Consumer Inquiries: 888-INFO-FDA
FDA approves production of imaging agent that helps detect prostate cancer
Mayo Clinic is the first facility approved to manufacture Choline C 11 Injection
The U.S. Food and Drug Administration today approved the production and use of Choline C 11 Injection, a Positron Emission Tomography (PET) imaging agent used to help detect recurrent prostate cancer.
Choline C 11 Injection is administered intravenously to produce an image that helps to locate specific body sites for follow-up tissue sampling and testing in men with recurrent prostate cancer.
PET imaging with Choline C 11 Injection is performed in patients whose blood prostate specific antigen (PSA) levels are increasing after earlier treatment for prostate cancer. An elevated PSA result suggests that prostate cancer may have returned, even though conventional imaging tests, such as computerized tomography (CT), have not shown any signs of cancer. PET imaging is not a replacement for tissue sampling and testing.http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm319201.htm
From the Early/Expanded Access Committee – Enzalutamide (MDV3100) Now available in 10 states (see below)
(more sites expected):
July 24 |
(Reuters) - Medivation Inc's experimental prostate cancer drug enzalutamide was granted priority review status by the U.S. Food and Drug Administration, potentially reducing the review time by half.
The drug, formerly called MDV3100, was developed in partnership with Japan's Astellas Pharma Inc for the treatment of men with castration-resistant prostate cancer previously treated with docetaxel-based chemotherapy.
The acceptance of the drug for review triggered a $10 million milestone payment to Medivation from Astellas, the companies said in a joint statement.
Prostate cancer kills about 250,000 men a year globally and the market for drugs to treat the disease is expected to grow to more than $10 billion in 2020, according to market research firm Decision Resources.
New and potential treatments for the deadly cancer are watched closely by industry analysts and investors alike. Drugs on the market include Johnson & Johnson's Zytiga and Dendreon Corp's vaccine Provenge. Bayer AG is also developing an experimental drug called alpharadin
BOSTON, July 30, 2012 /PRNewswire via COMTEX/ -- U.S. CONGRESS SETS HISTORIC PRECEDENT IN RECOGNIZING HEALTH CARE CRISIS KILLING AFRICAN AMERICAN MEN DISPROPORTIONATELY
U.S. Sen. John F. Kerry (D-MA) led unanimous passage of the Senate Resolution 493 to recognize prostate cancer as an epidemic striking African American men disproportionately, with 250% higher mortality and 60% higher incidence. This bipartisan legislation urges federal agencies to support research for the advancement of diagnostic tools, including novel biomarkers and imaging technologies. Improved diagnostic tools will save lives and assure individualized, the least invasive and the most cost-effective patient care in millions of American men.
Senator Kerry said, "Prostate cancer is an epidemic - it kills every 16 minutes. This disease killed my dad, but I was lucky to beat it ten years ago, I introduced this resolution in the Senate to bring attention to this silent killer, how it disproportionately affects African Americans, and the need for additional federal investment in prostate cancer research, education, and awareness. I've been through the battle against prostate cancer and I understand the strain a diagnosis places on the patient and their loved ones. We need to stay focused on research and arm Americans with the tools to prevent, detect, cure and treat this disease, and I'm grateful to my colleagues and our advocates for pushing this resolution through."
Dr. Faina Shtern, President of AdMeTech Foundation who worked with Senator Kerry and his staff for several years on prostate cancer research funding issues commented, "We applaud Senator Kerry's leadership in national recognition of prostate cancer as a public health priority and a health care crisis in African American men. This legislation offers hope to millions of men who are left in the state of shock and confusion by the recent recommendation of the US Preventive Services Task Force against PSA screening, the only diagnostic tool currently available for early detection. Ending PSA screening is not the answer to the prostate cancer crisis. The Kerry resolution in support of research to improve diagnostic tools is."
Prostate cancer is the most common malignancy in the United States, but federal research support is lagging behind, and men do not have reliable diagnostic tools. The impact is sobering: While prostate cancer is curable when detected early, it remains the second most lethal cancer in men, killing over 30,000 men each year.
Boston-based AdMeTech Foundation is a non-profit organization providing international leadership in prostate cancer research, education, and awareness ( www.admetech.org ).