Navigation Links
FDA Approves PROVENGE(R) for the Treatment of Men with Advanced Prostate Cancer
Date:4/29/2010

PROVENGE Safety

PROVENGE is intended solely for autologous use and is not routinely tested for transmissible infectious diseases.

The safety evaluation of PROVENGE was based on 601 prostate cancer patients in four randomized clinical trials who underwent at least one leukapheresis procedure. The most common adverse events (incidence ≥ 15%) are chills, fatigue, fever, back pain, nausea, joint ache, and headache.  Serious adverse events reported in the PROVENGE group include acute infusion reactions (occurring within 1 day of infusion) and cerebrovascular events.  In controlled clinical trials, severe (Grade 3) acute infusion reactions were reported in 3.5% of patients in the PROVENGE group. Reactions included chills, fever, fatigue, asthenia, dyspnea, hypoxia, bronchospasm, dizziness, headache, hypertension, muscle ache, nausea, and vomiting.  No Grade 4 or 5 acute infusion reactions were reported in patients in the PROVENGE group.

To fulfill a post marketing requirement and as a part of the company's ongoing commitment to patients, Dendreon will conduct a registry of approximately 1500 patients to further evaluate a small potential safety signal of cerebrovascular events. In four randomized clinical trials of PROVENGE in prostate cancer patients, cerebrovascular events were observed in 3.5% of patients in the PROVENGE arm compared with 2.6% of patients in the control arm.  

About PROVENGE and Patient Resources

PROVENGE (sipuleucel-T) is an autologous cellular immunotherapy indicated for the treatment of asymptomatic or minimally symptomatic metastatic, castrate resistant (hormone-refractory) prostate cancer.  PROVENGE represents the first product in a new therapeutic class known as autologous cellular immunotherapies.


'/>"/>
SOURCE Dendreon Corporation
Copyright©2010 PR Newswire.
All rights reserved

Page: 1 2 3 4 5 6 7

Related medicine technology :

1. FDA Approves Lillys Osteoporosis Drug EVISTA(R) (raloxifene HCl) to Reduce The Risk of Invasive Breast Cancer in Two Populations of Postmenopausal Women
2. Health Canada Approves ATRIPLA(R) (efavirenz 600 mg/emtricitabine 200 mg/ tenofovir disoproxil fumarate 300 mg), the First Once-Daily Single Tablet Regimen for HIV
3. FDA Approves Cymbalta(R) for Maintenance Treatment of Major Depressive Disorder
4. European Commission Approves ATRIPLA(R) (efavirenz 600 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg), the First Once-Daily Single Tablet Regimen for Virologically Suppressed Adults With HIV-1 Infection
5. FDA Approves MiddleBrooks Amoxicillin PULSYS for Pharyngitis/Tonsillitis in Adolescents and Adults
6. FDA Approves XYZAL(R) (levocetirizine dihydrochloride) Oral Solution for the Relief of Seasonal and Year Round Allergies and Chronic Idiopathic Urticaria
7. UM Maryland Industrial Partnerships Program Approves 18 Collaborative Research Projects, Worth $4.4 Million, Between University Faculty, State Technology Companies
8. U.S. Food and Drug Administration Approves ABILIFY(R) (aripiprazole) for the Acute Treatment of Manic and Mixed Episodes Associated With Bipolar I Disorder in Pediatric Patients (10 to 17 Years of Age)
9. U.S. Food and Drug Administration Approves ORENCIA(R) (abatacept) for the Treatment of Moderate-to-Severe Polyarticular Juvenile Idiopathic Arthritis (JIA) in Patients Six Years and Older
10. FDA Approves HIFU Clinical Trial for Recurrent Prostate Cancer
11. EPA Approves XDS-CALUX(R) as Alternate Dioxin Test Method 4435
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/3/2015)... 2015 TWi Pharmaceuticals, Inc. ("TWi") (stock ... final approval from the United States Food and ... Application (ANDA) for Guanfacine HCl ER tablet, the ... partner, Par Pharmaceuticals, will launch the product in ... indicated for the treatment of attention deficit hyperactivity ...
(Date:6/2/2015)... 3, 2015 Today, the world,s ... As markets become ever more transparent, the importance of ... recognised long ago. Its maxim of "innovation brings progress ... and digitisation. The company has long been ... of the art" technology and modern approach, while also ...
(Date:6/2/2015)... MENLO PARK, Calif. , June 2, 2015 /PRNewswire/ ... medical device company that is providing innovative evidence-based solutions ... pricing of an upsized underwritten public offering of its ... per share, before underwriting discounts. The offering consists of ... shares to be sold by certain of its stockholders, ...
Breaking Medicine Technology:Nevro Announces Pricing of Upsized Public Offering of Common Stock 2Nevro Announces Pricing of Upsized Public Offering of Common Stock 3
(Date:6/3/2015)... First Choice Emergency Room , the largest ... States, announced that it is opening its new San ... “I am pleased to announce that we are continuing ... the San Antonio area,” said Dr. James M. Muzzarelli, ... , First Choice Emergency Room is revolutionizing the delivery ...
(Date:6/3/2015)... 03, 2015 “ Scanalytics ” was ... Report, which features the latest and coolest technology products ... the host of NewsWatch, conducted the review and shared ... floor traffic in retail stores. , Tracking statistics in ... When it comes to retail this goes a step ...
(Date:6/3/2015)... ON (PRWEB) June 03, 2015 On ... a Marketing Authorization (MA), effective immediately, which now permits ... foods that contain oats as ingredients. The MA is ... being developed. All stakeholders should be aware that, unlike ... in the USA, there are restrictions for gluten-free oat ...
(Date:6/3/2015)... Fit Body Boot Camp is ... The company helps thousands of individuals across the country lose ... to hit the gym and get the fitness results they ... the most out any gym membership: , Tip #1 – ... gym memberships is saying motivated and on track. Attempting to ...
(Date:6/3/2015)... Washington, DC (PRWEB) June 03, 2015 ... podiatrist Dr. Casey Friske ( Clarksville ... Podiatrist Scholarship from the Symposium of Advanced Wound Care ... by APMA President-Elect Dr. Dan Davis. The Conference ... Henry B. Gonzalez Convention Center in San Antonio, TX. ...
Breaking Medicine News(10 mins):Health News:First Choice Emergency Room to Open New Facility in San Antonio, Texas 2Health News:Technology to Analyze Foot Traffic in Retail Stores was featured on NewsWatch Television 2Health News:Health Canada Allows For Conditional Use Of Gluten-Free Oats 2Health News:Health Canada Allows For Conditional Use Of Gluten-Free Oats 3Health News:Summer Body Slim-Down: 5 Ways to Avoid Quitting Gym Memberships this Summer 2Health News:Summer Body Slim-Down: 5 Ways to Avoid Quitting Gym Memberships this Summer 3Health News:Foot and Ankle Specialists of the Mid-Atlantic, LLC Receives Award at the Spring 2015 Symposium of Advanced Wound Care Conference 2
... ... ... chef supplies company located in Western Massachusetts, found themselves in search of a solution to ... an innovative resolution that not only solved an issue for catering professionals, but a solution ...
... Ore. , Jan. 14 The Tech-Aid Institute, ... work, has released another interactive CD-ROM for people with intellectual ... , With AIDS being the fifth leading cause of death ... States , this interactive computer program helps women with intellectual ...
... , ... medical and surgical equipment supplier — now offers the DRE Velocity EKG, a portable PC-based ... ... a Fast 50 Company by Business First of Louisville —offers the DRE Velocity EKG ...
... , ... VA Goal for Service-Disabled-Veteran-Owned Businesses , ... (PRWEB) January 14, 2010 -- 3D Global Solutions is pleased to announce that it ... award on the $800 million VA Digital Hearing Aid contract. The base year of the ...
... , ... injury attorney, Cliff Blackman, stresses importance of greater awareness of brain injuries and serious ... ... that occurred on New Year,s Day, in which top-ranked American snowboarder Kevin Pearce suffered ...
... ... , ... 2010 -- Morehead, the human capital research firm, will host a ,webinar titled “The ... ,be broadcast on Thursday, February 4, 2010 at 1:00 p.m. EST. , , ,Join ...
Cached Medicine News:Health News:Insulated Transport Containers Go Green 2Health News:The Tech-Aid Institute Releases HIV/AIDS Prevention Software for Women with Intellectual Disabilities 2Health News:Cost-effective PC-based EKG Now Available from DRE 2Health News:Cost-effective PC-based EKG Now Available from DRE 3Health News:3D Global Solutions Selected to Program Manage GN ReSound/VA Digital Hearing Aid Contract 2Health News:3D Global Solutions Selected to Program Manage GN ReSound/VA Digital Hearing Aid Contract 3Health News:Snowboarding Accident Provides Tragic Reminder of Serious Risk of Brain Injuries in Athletic and Occupational Environments 2Health News:Morehead Presents Webinar on “The State of Physician Engagement: A Year in Review” 2
Foam Cervical Collar is medium-firm density. Breathable. Deeply anatomically contoured. Natural color, 100% cotton stockinette-covered for comfort. 2" hook and loop closures are another mark of quali...
Ezy Wrap® Economy Contour Cervical Collar Medium-density urethane foam. Synthetic white stockinette cover. Reverses for flexion or extension. (Contact closure. Hand wash. Air dry. 10/pack.)...
Exo-Deluxe Overhead Traction for hospital or home care. Twice the clearance of other units between the patient and supporting wall. 2" nylon pulleys with polypropylene cord, head halter, spreader bar...
... Aspen® Cervical Collars improves patient compliance, ... costs. Adjusts to user's anatomy, wicks ... head weight to shoulders and upper ... Front and back airflow openings. Adjustable ...
Medicine Products: