Navigation Links
FDA Approves Xalkori with Companion Diagnostic for a Type of Late-stage Lung Cancer
Date:8/26/2011

d received prior chemotherapy.

In one study, the objective response rate was 50 percent with a median response duration of 42 weeks. In another, the objective response rate was 61 percent with a median response duration of 48 weeks.

The FDA based its approval of the Vysis ALK Break Apart FISH Probe Kit on data from one of the studies.

Xalkori was reviewed under the FDA's priority review program, which provides for an expedited six-month review of drugs that may offer major advances in treatment or that provide a treatment when no adequate therapy exists.

Xalkori is being approved under the FDA's accelerated approval program, which allows the agency to approve a drug to treat a serious disease based on clinical data showing that the drug has an effect on an endpoint that is reasonably likely to predict a clinical benefit to patients. The program is designed to provide patients with earlier access to promising new drugs, followed by further studies to confirm the drug's clinical benefit.

Xalkori and the companion Vysis ALK Break Apart FISH Probe Kit were approved ahead of the drug's Sept. 30, 2011, FDA review goal date and the companion diagnostics' Sept. 28, 2011, review goal date. 

"The trend in oncology research continues towards targeted therapies," said Alberto Gutierrez, Ph.D., director of the Office of In Vitro Diagnostic Device Evaluation and Safety in the FDA's Center for Devices and Radiological Health. "This test is an example of the important role companion diagnostics play in determining that the safest and most effective treatments are promptly delivered to patients living with serious and life-threatening diseases."

The most common side effects reported in patients receiving Xalkori included vision disorders, nausea, diarrhea, vomiting, swelling (edema), and constipation. Vision disorders included visual impairment, flashes of light, blurred vision, floaters, double vision, sensitivity to light, and
'/>"/>

SOURCE U.S. Food and Drug Administration
Copyright©2010 PR Newswire.
All rights reserved

Page: 1 2 3 4

Related medicine technology :

1. FDA Approves Firazyr To Treat Acute Attacks of Hereditary Angioedema
2. FDA Approves Adcetris to Treat Two Types of Lymphoma
3. FDA Approves the First Specific Treatment for Scorpion Stings
4. Cardinal Health Board of Directors Approves Cash Dividend, Elects David P. King as Director
5. FDA Tentatively Approves Intellijects Lead Product, e-cue™
6. FDA Approves New Medicine BRILINTA™ (Ticagrelor) for Use in the US
7. FDA Approves Vaccines for the 2011-2012 Influenza Season
8. FDA Approves Boostrix to Prevent Tetanus, Diphtheria, and Pertussis in Older People
9. FDA Approves Arcapta Neohaler to Treat Chronic Obstructive Pulmonary Disease
10. FDA Approves XARELTO® (rivaroxaban tablets) to Help Prevent Deep Vein Thrombosis in Patients Undergoing Knee or Hip Replacement Surgery
11. FDA Approves Lazanda® - First Fentanyl Nasal Spray - for the Management of Breakthrough Pain in Cancer Patients
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:12/24/2014)... , Dec. 23, 2014   Synageva ... a biopharmaceutical company developing therapeutic products for rare ... Agency (EMA) of the Marketing Authorization Application (MAA) ... recently granted the company,s request for accelerated assessment, ... regulatory review time.   The MAA, ...
(Date:12/24/2014)... , Dec. 23, 2014 In response to ... Association of Sierra Leone , Direct Relief ... for the treatment of local health workers who ... a new dedicated Ebola care center was constructed for foreign ... facility is not available for local Sierra Leonean health workers. ...
(Date:12/22/2014)... 2014 Apnea Sciences ( www.apneasciences.com ) announced ... Aliso Viejo , California.  Jimmy Fallon ... growth and worldwide expansion, a new facility with expanded ... anti snore cure have exceeded our expectations and thus ... now in 23 countries and will be increasing to ...
Breaking Medicine Technology:Synageva BioPharma Announces Sebelipase Alfa Marketing Authorization Application Validated By The EMA 2Synageva BioPharma Announces Sebelipase Alfa Marketing Authorization Application Validated By The EMA 3First Ebola Treatment Unit for Local Health Workers Arrives in Sierra Leone 2
... Pharmaceutical companies are dramatically increasing their investments ... demands of a patient-empowered, data-driven, outcomes-focused future in ... company investment in smart phone apps, educational websites, ... increased 78%, as companies embrace a role that ...
... Inc. (Nasdaq: MLAB ) today announced that ... cash dividend of 12 cents per share of common ... record at the close of business on February 25, ... markets electronic instruments and disposables for industrial, pharmaceutical and ...
Cached Medicine Technology:Pharmaceutical Industry Rapidly Expanding Partnerships With New Entrants in Health Care Space, Ernst & Young Finds 2Pharmaceutical Industry Rapidly Expanding Partnerships With New Entrants in Health Care Space, Ernst & Young Finds 3Pharmaceutical Industry Rapidly Expanding Partnerships With New Entrants in Health Care Space, Ernst & Young Finds 4Pharmaceutical Industry Rapidly Expanding Partnerships With New Entrants in Health Care Space, Ernst & Young Finds 5
(Date:12/25/2014)... The click strand woven bamboo flooring ... Today, the business announces a click strand woven ... 30, 2015. , Click strand woven bamboo flooring ... a well-known brand in the bamboo industry. It ... reliable bamboo flooring supplier. , “We are happy ...
(Date:12/25/2014)... 26, 2014 Recently, iFitDress.com, the popular online ... has announced its new selection of black one-shoulder cocktail ... sale now; they are available at discounted prices, up to ... promotion will last for three weeks only. You know, we ... who are interested in our new items can visit our ...
(Date:12/25/2014)... (PRWEB) December 25, 2014 Helen Harris’ ... in Woodland Hills, California after an 8 year battle ... on Christmas Eve evening in her home in Woodland ... metastatic breast cancer. , As the ... forty years, she pioneered and championed many of today's ...
(Date:12/25/2014)... -- Overeating is common during the holidays, but there are ... says. "Don,t arrive at a party hungry. It may ... be attending a party, but deprivation leads to hunger, and ... Westchester Hospital in Mount Kisco, N.Y., said in a hospital ... day and even to have a snack before attending a ...
(Date:12/25/2014)... 2014 “ SmileStix ” was featured on ... latest and coolest mobile applications on the iOS, Android, and ... of NewsWatch, conducted the app review and shared with viewers ... stickers. , The old saying goes, “A picture says a ... that can describe a single image, because each picture holds ...
Breaking Medicine News(10 mins):Health News:BambooFlooringChina.com: click strand woven bamboo flooring promotion valid until Jan. 30, 2015. 2Health News:iFitDress.com: Black One-Shoulder Cocktail Dresses for 2015 2Health News:RP International founder, Helen Harris Dies on Christmas Eve Just Hours Before Her Holiday Television Broadcast to Raise Funds to Cure Blindness was Broadcasted Nationally 2Health News:RP International founder, Helen Harris Dies on Christmas Eve Just Hours Before Her Holiday Television Broadcast to Raise Funds to Cure Blindness was Broadcasted Nationally 3Health News:RP International founder, Helen Harris Dies on Christmas Eve Just Hours Before Her Holiday Television Broadcast to Raise Funds to Cure Blindness was Broadcasted Nationally 4Health News:An Application to Create Custom Stickers was Featured on NewsWatch Television on December 19, 2014 2
... cause of death and disease in the U.S., with more ... consequences. And yet teens still smoke. Indeed, smoking usually begins ... smokers became hooked by the time they were 18. Meanwhile, ... While studies have linked cigarette smoking to deficits ...
... K. Ganguly, Distinguished Research Professor of Chemistry at ... Award Lecture at the University of Michigan. Named ... G. Topliss, the lectures were established to recognize ... and industrial scientists. Dr. Ganguly,s lecture, "Drug Discovery ...
... is the most frequently mutated in human cancer. It encodes ... acts primarily as a regulator of how genes are made ... of Medicine show that the protein has at least one ... one of body,s main sources of fuel. These new insights ...
... (HealthDay News) -- Epilepsy patients who are poor are ... and a lower overall quality of life compared to ... Poor patients also visit hospital emergency departments more often ... to lead author Dr. Charles E. Begley, professor of ...
... sometimes help diagnose juvenile idiopathic arthritis (JIA), a physical ... tools in identifying this disease. According to a new ... Academy of Orthopaedic Surgeons (JAAOS), the rate of ... to screen for juvenile arthritis makes their value limited. ...
... has awarded Arizona State University (ASU) a $1 million ... Meldrum, Ph.D., at the Biodesign Institute. The team is ... called a "Cell-CT" scanner, that will perform functional computed ... technology will allow researchers to observe and assess the ...
Cached Medicine News:Health News:Tobacco smoking impacts teens' brains, UCLA study shows 2Health News:Tobacco smoking impacts teens' brains, UCLA study shows 3Health News:Stevens' Dr. A. K. Ganguly receives Topliss Award Lecture from University of Michigan 2Health News:Penn researchers find new role for cancer protein p53 2Health News:Penn researchers find new role for cancer protein p53 3Health News:Joint pain in children: Is it just a sore knee, or ... ? 2Health News:$1 million from W.M. Keck Foundation spurs development of new generation 3-D 'Cell-CT' imaging 2Health News:$1 million from W.M. Keck Foundation spurs development of new generation 3-D 'Cell-CT' imaging 3
... Pipette is a synonym for pipetting accuracy, ... design, and superior operating comfort. Its single, ... measuring stroke and blow-out as well as ... ensures utmost accuracy and precision. Ejection sleeve ...
... is ideal for repeated pipetting ... volume FInnpipettes offer the same ... Finnpipette Digital pipettes: New, ... Soft-touch tip ejection, Safety label, ...
Inquire...
... A fixed pipette is ... a single volume. Fixed volume ... and advantages as other Finnpipette ... design, Super blow-out (1-40ul), Soft-touch ...
Medicine Products: