Zytiga Clinical Studies

ARIXTRA. ARIXTRA Initial U.S. Approval: 2001 WARNING: SPINAL ...
Prophylaxis clinical studies of hip fracture, hip replacement, or knee replacement surgery according to the time of the first injection of ARIXTRA after surgical closure was performed in patients who received ARIXTRA only post-operatively. ... Read Document

ERIVEDGE. (5.2) ERIVEDGE Initial U.S. Approval: 2012 ADVERSE ...
263 14 CLINICAL STUDIES 264 A single, international, single-arm, multi-center, open-label, 2-cohort trial was conducted in 265 104 patients with either metastatic basal cell carcinoma (mBCC) (n = 33) or locally advanced BCC 266 (laBCC) (n = 71). ... Read Document

Institute Of Cancer Research - Wikipedia, The Free Encyclopedia
The first clinical trial of carboplatin was carried (the most common form of brain tumour), it decreased the growth of ovarian tumours and in other studies, it was active against cell lines The FDA in April 2011 approved the drug for sale in the US under the trade name Zytiga. ... Read Article

Volume XXIX, No. 10 New Drugs: Horizant, Caprelsa, Yervoy ...
Yervoy, and Zytiga Volume XXIX, No. 10 Dr. Thomas A. Gossel and Dr. J. Richard :XHVW KDYH QR UHOHYDQW ÀQDQFLDO UHODWLRQ-ships to disclose. pharmacologic action and clinical application for each drug; originate from studies of mela-noma. ... Access Document

SR-1346.02, 28 SEP 2009 Page 1 Of 23 Dendreon Corporation
14 CLINICAL STUDIES . 14.1 IMPACT Study (D9902B) 14.2 Study D9901 . 14.3 Study D9902A . 14.4 Summary of Overall Survival . 16 HOW SUPPLIED/STORAGE AND HANDLING . 17 PATIENT COUNSELING INFORMATION . 17.1 Physician Information . 17.1.1 Preparation and Schedule . ... Access Full Source

TREATMENT OF Prostate Cancer - Magellan Health Services
Clinical studies that suggest beneficial use in some cases • Ancillary medications used in cancer treatment • Reimbursement and coding information (Zytiga) J8999* — prescription drug, oral, chemotherapeutic, not otherwise specified ... Retrieve Here

Prostate Cancer Clinical Trials - Understanding Prostate ...
Clinical trials, sometimes known as clinical studies, are conducted in order to test new ways in which to prevent, diagnose, treat, or monitor prostate cancer. What should you know about clinical trials? ... Read Article

Prior Authorization/Step Therapy Program
Product labeling, clinical studies and/or clinical guidelines and according Zytiga Helps ensure appropriate selection of patients for treatment according to product labeling, clinical studies and/or clinical guidelines. A quantity limit encourages appropriate, FDA-approved dosing. ... View Doc

NEWS RELEASE
Endpoint in Phase 3 mCRPC studies,” said Charles J. Ryan, M.D., ®AI has been reported in clinical trials in patients receiving ZYTIGA in combination with prednisone, after an interruption of daily steroids and/or with concurrent infection or ... View Full Source

WARNINGS AND PRECAUTIONS----- HIGHLIGHTS OF ...
In clinical studies 38%-40% of patients were ≥60 years of age and 10%-12% of patients were ≥70 years of age. Chronic Phase, Prior Interferon-Alpha Treatment: 532 patients were treated at a starting dose of 400 mg; dose escalation to 600 mg was allowed. ... Get Doc

HIGHLIGHTS OF PRESCRIBING INFORMATION ...
14 CLINICAL STUDIES The efficacy and safety of XTANDI in patients with metastatic castration-resistant prostate cancer who had received prior docetaxel-based therapy were assessed in a randomized, placebo-controlled, multicenter phase 3 clinical trial. ... Fetch Full Source

Prostate Cancer - Your Guide To Symptoms, Diagnosis ...
Your guide to prostate cancer. Everything you need to know about prostate cancer symptoms, diagnosis, treatment, risks, prevention, and the PSA test. Learn more about all aspects of prostate cancer here. Blog ... Read Article

Tapentadol - Wikipedia, The Free Encyclopedia
Clinical studies cite there is less incidence of select adverse gastrointestinal effects with the administration of tapentadol when compared to oxycodone. A relative high incidence of hallucinations have been reported, ... Read Article

Leuprorelin - Wikipedia, The Free Encyclopedia
Leuprorelin (INN) or leuprolide acetate (USAN) is a GnRH analog. Proper Sequence: Pyr-His-Trp-Ser-Tyr-D-Leu-Leu-Arg-Pro-NHEt (Pyr = L-Pyroglutamyl) Leuprolide acts as an agonist at pituitary GnRH receptors. By interrupting the normal pulsatile stimulation and the desensitization of the GnRH ... Read Article

HIGHLIGHTS OF PRESCRIBING INFORMATION QT Prolongation: Use ...
Clinical studies, 15 patients (<1%) had QTc prolongation reported as an adverse reaction. Twenty-two patients (1%) experienced a QTcF >500 ms. In 865 patients with leukemia treated with SPRYCEL in five Phase 2 single-arm studies, the maximum mean ... Read Here

New Drug Review 2001: A Formulary Approach
Asenapine (Saphris ®) Efficacy Three 6 week studies for schizophrenia Randomized, placebo and active drug-controlled, double-blind Study 1 – both asenapine and risperidone > placebo (Zytiga) Approval was based on a clinical trial of 1,195 patients with late-stage, ... Access Doc

Dendreon's Roller Coaster Still Rocking
Dendreon's Roller Coaster Still Rocking ... Read News

Sandostatin® Lar Depot - Novartis: Broad Healthcare ...
Clinical studies of Sandostatin did not include sufficient numbers of subjects age 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified ... Return Document

Iron Chelating Agents - Affordable Health Insurance From BMC ...
Conclusions based upon the regulatory status of the technology and a review of clinical studies published in peer-reviewed medical literature. Even though this policy may indicate that a particular service or supply is considered covered or not covered, this conclusion is not based ... Fetch This Document

Unlocking The Value Of Science GenSpera, Inc. (GNSZ)
ZYTIGA inhibits a protein called CYP17A1 (17 α-hydroxylase/C17,20 lyase), which plays a key role in the In clinical studies, PROVENGE therapy showed an overall survival benefit of approximately 4.5 months. ... Read Document

Chelation Therapy - Health Plan Of Nevada, Inc. - HPN
Testimonials and single-case studies. Thus, there still is no scientific evidence that demonstrates any and if the clinical record justifies the diagnosis of heavy metal poisoning, and if the particular therapy was both reasonable and necessary. ... Doc Retrieval

Re-submission - Scottish Medicines Consortium Home
Summary of clinical effectiveness issues and a systematic review failed to identify any studies to allow the submitting company to perform an abiraterone (Zytiga®), www.ema.europa.eu Procedure No: EMEA/H/C/002321 4. ... View Doc

Prostate Cancer
Autopsy studies show that many older men being tested in clinical trials. No other drug or supplement has been found to be helpful in studies large enough to allow experts to recommend they should be given to men. Abiraterone (Zytiga ... Access This Document

Prior Authorization - Prime Therapeutics
Selection of patients for treatment according to product labeling and/or clinical studies and clinical guidelines. Zytiga 120 tabs Pain Conzip 30 tabs Nucynta ER 60 tabs Suboxone/Subutex 15 tabs / 90 days Vaccines Influenza ... Read Full Source

Navigating The Oncology Marketplace - Confera Group
11:00 Epidemiology & Clinical Development Concepts in Oncology continued Roger Halualani, Partner, Epiphany Partners Inc. - Case Studies (e.g., Provenge, Yervoy and Zytiga) New approaches to management (e.g., Chronic Myeloid Leukemia) ... Retrieve Document

ZETIA (ezetimibe) Tablets Patient Information About ZETIA (z ...
In clinical studies patients reported few side effects while taking ZETIA. These included diarrhea, joint pains, and feeling tired. Patients have experienced severe muscle problems while taking ZETIA, usually when ZETIA was added to a statin drug. ... Access Doc

What Options Exist For Advanced Prostate Cancer - Options For ...
Cabazitaxel received FDA approval in large part due to the positive results that came out of a Phase III clinical study comparing the drug with mitoxantrone, (Zytiga) is a drug that Studies have shown increased survival, ... Read Article