Navigation Links
FDA to Review Potential New Use of XGEVA® (Denosumab) at Oncologic Drugs Advisory Committee Meeting
Date:12/29/2011

THOUSAND OAKS, Calif., Dec. 29, 2011 /PRNewswire/ -- Amgen (NASDAQ: AMGN) today announced the U.S. Food and Drug Administration (FDA) has invited the Company to participate in a meeting of the Oncologic Drugs Advisory Committee (ODAC) on Feb. 8, 2012 to discuss the supplemental Biologics License Application (sBLA) for XGEVA® (denosumab) to treat men with castration-resistant prostate cancer (CRPC) at high risk of developing bone metastases.

The ODAC will review results from clinical studies in support of this new indication, including the pivotal '147 trial, a randomized, placebo-controlled, multi-center Phase 3 study that compared XGEVA to placebo in prolonging bone metastasis-free survival in men with non-metastatic CRPC who were at high risk for bone metastases based on prostate specific antigen criteria. 

Amgen plans to discuss the proposed sBLA with ODAC, to support the use of XGEVA in the treatment of men with non-metastatic CRPC; a patient population for whom there are no approved treatments to delay or prevent the spread of cancer to bone.

The sBLA was submitted on June 27, 2011, and a Prescription Drug User Fee Act action date has been scheduled for April 26, 2012.  If approved, this will be the second indication for XGEVA in the United States (U.S.).

About XGEVA

XGEVA is the first and only RANK Ligand inhibitor approved by the FDA indicated for the prevention of skeletal-related events (SREs) in patients with bone metastases from solid tumors. XGEVA was initially approved following a six month priority review by the FDA.  XGEVA is not indicated for the prevention of SREs in patients with multiple myeloma. XGEVA is the first novel bone metastases treatment for advanced cancer patients in nearly a decade. Delivered as an every four week 120 mg subcutaneous injection, XGEVA provides a unique option for urol
'/>"/>

SOURCE Amgen
Copyright©2010 PR Newswire.
All rights reserved

Page: 1 2 3 4 5 6 7 8

Related medicine technology :

1. VIVUS Announces Date of FDA Advisory Committee Review of Qnexa for the Treatment of Obesity
2. Bipartisan Group of 22 House Members ask CMS to Stop Prepayment Review Project that would Jeopardize Care for Medicare Beneficiaries
3. Anthera Announces Completion of Safety Review by DSMB for VISTA-16
4. Homecare Providers and Consumer Advocates Urge Congress to Stop Ineffective Medicare Payment Review Process for Mobility Equipment
5. M&A Surges, Companion Diagnostics Accelerate, and Early Detection Offers New Prospects, Finds PwCs Biennial Review of the In Vitro Diagnostics Industry
6. Physicians Capital Investments Announces Pedro Vergne-Marini, MD Named to Beckers ASC Review "350 People in the ASC Industry to Know"
7. Avreo Previews Version 7 RIS/PACS at RSNA
8. Futuremed and Cardinal Health Canada Inc. Report on Developments in Competition Bureau Review of the Proposed Acquisition
9. Regeneron Announces FDA Acceptance of ARCALYST® (rilonacept) Supplemental Biologics License Application for Review
10. U.S. Food and Drug Administration (FDA) Delays Review of Takedas Investigational Type 2 Diabetes Therapies, Alogliptin and Alogliptin/Pioglitazone
11. Columbia Laboratories and Watson Pharmaceuticals Confirm FDA Advisory Committee to Review Preterm Birth NDA
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:7/29/2014)... -- Apex Medical Corporation (Apex, TWSE: 4106), a leading player ... that it is appealing the judgment of the Regional Court ... that found the headgear of certain mask models ... invalidity challenges against various ResMed patents in major countries. Apex ... junk patents. ResMed filed the lawsuit with ...
(Date:7/29/2014)... 29, 2014  Ambit Biosciences (Nasdaq: AMBI ), ... drugs targeting unmet needs in oncology, autoimmune and inflammatory ... results after closing of the NASDAQ Global Market on ... call hosted by Michael Martino , president and ... place on the same day at 5:00 pm EDT ...
(Date:7/29/2014)... , July 29, 2014  The BioFusionary ... on developing a proprietary electromagnetic induction platform with ... into an agreement under which TBC will merge ... Limited (COT) in an all-stock transaction. ... initially trade on the Australian Stock Exchange under ...
Breaking Medicine Technology:Apex Continues Fighting Against Patents to Free Up Competition 2Ambit Biosciences To Announce Second Quarter 2014 Financial Results 2The BioFusionary Corporation, Inc. Announces Intent To Complete Reverse Takeover Of Australia-Based Continuation Investments Limited 2The BioFusionary Corporation, Inc. Announces Intent To Complete Reverse Takeover Of Australia-Based Continuation Investments Limited 3
... Immunomedics, Inc. (Nasdaq: IMMU ) , ... to treat cancer and other serious diseases, today ... Cancers Symposium showed that labetuzumab-SN-38, an antibody-drug conjugate, ... animal models as an effective new therapy. ...
... Fla., Jan. 19 A new approach to unblocking ... down time, lower costs and less risk overall, particularly ... the 21st annual International Symposium on Endovascular Therapy (ISET). ... over bypass surgery to open their blocked arteries. New ...
Cached Medicine Technology:Immunomedics Announces Preclinical Therapy Results of SN-38 Immunoconjugate for Colorectal Cancer 2Immunomedics Announces Preclinical Therapy Results of SN-38 Immunoconjugate for Colorectal Cancer 3Wrist Access Safer, Easier for Many Patients Undergoing Minimally Invasive Treatment of Blocked Heart Arteries 2
(Date:7/29/2014)... Little Rock, AR (PRWEB) July 29, 2014 ... S.Res.518 , a resolution declaring the week of October ... the value of case management in improving healthcare outcomes ... Pryor (D-AR) and Senator John Boozman (R-AR), with support ... American Case Management Association to honor case management professionals ...
(Date:7/29/2014)... 29, 2014 “Our years of ... homeowners fail to insulate their homes properly simply ... of preventing heat transfer and conduction,” Clean Crawls ... they’ve recently released an article explaining exactly how ... their energy bills. , To contact Clean Crawls ...
(Date:7/29/2014)... “Approximately 18% of our population suffers from allergies, ... Western Washington Medical Group says in their recently ... from allergies to seek medical attention. , “Billions of ... in the United States,” they continue. “Many people have ... themselves, rather than seeking the appropriate treatment.” , Fortunately, ...
(Date:7/29/2014)... Award-winning inventor Michael Croix has launched an Indiegogo campaign ... absorb embarrassing odors in the office. PoofPad is a discrete ... a desk drawer. This compact packaging is designed for ease ... on the pad and poof away! , “We’ve all been ... someone appears out of nowhere. It’s embarrassing and unpleasant for ...
(Date:7/29/2014)... 29, 2014 Riverdale Urgent Care is ... do. Through their presence at local events, partnerships and ... more than just a medical service for the Riverdale ... money in support of Riverdale RiverFest and South Riverdale ... that features local musicians and entertainers, arts and crafts, ...
Breaking Medicine News(10 mins):Health News:CMSA Supports National Case Management Week Resolution Introduced in US Senate 2Health News:What’s The Point of Insulation? Clean Crawls Explains The Dangers of Heat Transfer in Recently Released Article 2Health News:Allergy Sufferers are Urged to Seek Medical Help in Recent Article by Western Washington Medical Group 2Health News:Allergy Sufferers are Urged to Seek Medical Help in Recent Article by Western Washington Medical Group 3Health News:Award-Winning Inventor Michael Croix Launches an Indiegogo Campaign for PoofPad 2Health News:Award-Winning Inventor Michael Croix Launches an Indiegogo Campaign for PoofPad 3Health News:Riverdale Urgent Care of the Bronx, NY Puts a Face Back on Medicine 2Health News:Riverdale Urgent Care of the Bronx, NY Puts a Face Back on Medicine 3
... Regions Hospital,this week opens a new 16-bed inpatient ... the region -- with an innovative way of caring ... schedule,providing improved continuity and a better experience for patients., ... provide care for,patients once they arrive in the emergency ...
... Late-Stage and Marketed ... ... England, February 18 /PRNewswire/,-- EUSA Pharma Inc (,EUSA,), a transatlantic ... today,announced that it has out-licensed the exclusive world-wide rights to ...
... Cancer Society study of twelve types of cancer among ... were significantly more likely to present with advanced stage ... which appears in the March issue of The Lancet ... investigate insurance status and stage of diagnosis for a ...
... known to impair the cognitive health of people, but ... learning and memory problems. A new National Institutes ... increased levels of a stress hormone produced by the ... the region of the brain responsible for learning and ...
... District Hospital, Dar es Salaam, Tanzania, WASHINGTON, Feb. ... President, First Lady, my dear wife -- Mr.,President, welcome again ... you so much, again, for PEPFAR, the President,s,Emergency Plan for ... -- these two buildings, a,facility we just visited, and again, ...
... Wing, professor of psychiatry and human behavior at The Warren ... Weight Control & Diabetes Research Center at The Miriam Hospital, ... dieters who lose weight and keep the pounds off, have ... , Using new research findings, Wing will make her case ...
Cached Medicine News:Health News:Regions Hospital to Open New Inpatient Behavioral Health Unit 2Health News:EUSA Pharma Out-Licenses Preclinical-Stage Human Antibody to GlaxoSmithKline for up to $44 Million Plus Royalties 2Health News:EUSA Pharma Out-Licenses Preclinical-Stage Human Antibody to GlaxoSmithKline for up to $44 Million Plus Royalties 3Health News:Major study links insurance status to advanced stage in multiple cancers 2Health News:Stress hormone impacts memory, learning in diabetic rodents 2Health News:Remarks By President Bush and President Kikwete of Tanzania at Roundtable on Pepfar 2Health News:Large changes needed to address global obesity epidemic 2
1.7% Tryptone, 0.3% Soytone, 0.5% Sodium Chloride, 0.25% Dextrose, 0.25% Potassium Phosphate....
Penicillin G (1 x 10 4 units/mL and Streptomycin (10mg/mL) Solution. 100X Concentrate....
Penicillin-Streptomycin-Glutamine (100X) liquid...
Contains 10,000 units of penicillin (base), 10,000 g of streptomycin (base), and 25 g of amphotericin B/ml utilizing penicillin G (sodium salt), streptomycin sulfate, and amphotericin B as Fungizone ...
Medicine Products: