Navigation Links
FDA Approves New Indication for Afinitor
Date:11/1/2010

SILVER SPRING, Md., Nov. 1, 2010 /PRNewswire-USNewswire/ -- The U.S. Food and Drug Administration approved the cancer drug Afinitor (everolimus) on Friday to treat patients with subependymal giant cell astrocytoma (SEGA) associated with tuberous sclerosis (TS), a rare genetic disorder. This approval was for treatments of SEGA that can not be treated with surgery.

(Logo: http://photos.prnewswire.com/prnh/20090824/FDALOGO)

(Logo: http://www.newscom.com/cgi-bin/prnh/20090824/FDALOGO)

TS causes benign (non-cancerous) tumors to grow in the brain and in other parts of the body including the eyes, lungs, liver, heart, skin and kidneys. TS occurs as a result of genetic mutations that lead to the development of tumors and results in a variety of possible symptoms including learning and developmental disabilities, skin abnormalities, seizures, and lung and kidney disease.

SEGAs are considered a major diagnostic feature of TS and are slow growing tumors, seen in 6 percent to 9 percent of patients. The disease can be fatal for patients who develop complications with tumor growth on the brain. Surgery is used to remove the tumor growths in some patients.

"Patients with this disease currently have limited treatment options beyond surgical intervention," said Richard Pazdur, M.D., director of the Office of Oncology Drug Products in the FDA's Center for Drug Evaluation and Research. "It is important for research to continue in rare diseases where patients have few or no existing drug treatment options."

The drug was approved under the FDA's accelerated approval program. The program allows the FDA to approve a drug to treat serious diseases with an unmet medical need based on an endpoint thought to reasonably predict clinical benefit. The company is required to collect additional long term efficacy and safety data confirming the drug's benefit. This program provides earlier patient access to promising new or existing drugs while the confirmatory clinical trials are being conducted.

Afinitor was first approved in March 2009 to treat kidney cancer after patients fail treatment with Sutent (sunitinib) or Nexavar (sorafenib).

A single study of 28 patients was used to evaluate the safety and effectiveness of Afinitor to treat SEGA. At six months into the study, nine patients (32 percent) had a greater than 50 percent reduction in space the tumor occupied (tumor volume) of their largest SEGA tumor lesion. The length of time from when a patient's tumor visibly shrank and then remained stable (duration of response) for these nine patients ranged from about three months to two and one-half years with a median of 266 days. Seven of these patients retained the greater than 50 percent reduction in space the tumor occupied at time of last follow up.

Patients participating in the study did not develop any new tumors. However, no tumor resolved completely. Four of the patients on this study had previous surgery, but their tumor grew back. After receiving Afinitor, three of these patients experienced greater than 50 percent reduction in tumor volume.

In patients treated with Afinitor for SEGA, the most commonly reported side effects included upper respiratory tract infections, sinus and ear infections, mouth sores, and fever. Common laboratory test abnormalities included liver enzyme elevations, high blood cholesterol and triglycerides (hyperlipidemia), high blood sugar, and decreases in white blood cells, red blood cells (anemia), and platelets. In patients with kidney cancer (renal cell carcinoma), lung inflammation (pneumonitis) and decreases in kidney (renal) function also have been reported.

Everolimus is also approved under an alternative trade name, Zortress, for prophylaxis of organ rejection in adult patients at low-moderate immunologic risk receiving a kidney transplant. Zortress has a different safety profile in these patients. Please refer to the Zortress prescribing information.

Afinitor is marketed by East Hanover, N.J.-based Novartis.

For more information:

FDA: Office of Oncology Drug Products

http://www.fda.gov/AboutFDA/CentersOffices/CDER/ucm091745.htm

FDA: Approved Drugs: Questions and Answers

http://www.fda.gov/Drugs/ResourcesForYou/Consumers/ucm054420.htm

Media Inquiries: Erica Jefferson, 301-796-4988, erica.jefferson@fda.hhs.gov

Consumer Inquiries: 888-INFO-FDA




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

Related medicine technology :

1. FDA Approves Teflaro for Bacterial Infections
2. FDA Approves Latuda to Treat Schizophrenia in Adults
3. FDA Approves Additional Medical Indication for Sprycel
4. FDA Approves Pradaxa, Marking a Major Milestone to Reduce the Risk of Stroke in Patients with Non-Valvular Atrial Fibrillation
5. FDA Approves Pradaxa to Prevent Stroke in People With Atrial Fibrillation
6. FDA Approves Botox to Treat Chronic Migraine
7. FDA Approves Injectable Drug to Treat Opioid-Dependent Patients
8. FDA Approves Pharmaxis ARIDOL™ (Mannitol Inhalation Powder) Bronchial Challenge Test Kit for the Assessment of Bronchial Hyperresponsiveness
9. FDA Approves Combination Contraceptive Containing a Folate
10. U.S. FDA Approves New Oral Contraceptive That Also Raises Folate Levels
11. FDA Approves NDA That Includes Psychiatric Data Collected by Centralized Raters
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:12/2/2016)... Dec. 2, 2016  PipelineRx, a leading medication management ... offering demonstrations of its SaaS-based telepharmacy platform, ... Pharmacists 2016 Midyear Clinical Meeting and Exhibition, December ... With nearly 300 hospital clients nationally, the Company ... designed to dramatically improve pharmacy operations, enhance patient ...
(Date:12/2/2016)... Va. , Dec. 2, 2016  The ... by the Academy of Managed Care Pharmacy (AMCP), ... organizations can better address the opioid addiction crisis, ... Assisted Therapies (MAT). ATAG,s newly released ... Improving Access to Naloxone," addresses many issues around ...
(Date:12/2/2016)... bioLytical Laboratories, ein Weltführer bei schnellen Tests für ... Apothekenbundes von Kenia eingeführt. Continue Reading ... ... Test! (PRNewsFoto/bioLytical Laboratories) ... http://photos.prnewswire.com/prnh/20161201/444905 ) bioLytical wurde durch die ...
Breaking Medicine Technology:
(Date:12/2/2016)... ... 02, 2016 , ... Mediaplanet is proud to announce the ... the innovative treatments, therapeutic technologies, and revolutionized nutrition that are helping patients and ... 6 years in the last 3 decades,” says Dr. Valentine Fuster, a world-renowned ...
(Date:12/2/2016)... ... December 02, 2016 , ... Universal ... systems and the first company to offer robotic imaging to veterinary medicine ... tradeshow booth # 941 for the American Association of Equine Practitioners 62nd Annual ...
(Date:12/2/2016)... (PRWEB) , ... December 02, 2016 , ... Yisrayl Hawkins, ... delves into how this current generation fits into Bible Prophecy. Yisrayl says this generation, ... facts pointing to this conclusion, showing how the details line up exactly with Bible ...
(Date:12/2/2016)... ... December 02, 2016 , ... On November 24th, 2016, ... from eight different sites throughout Miami-Dade and Broward counties. This is the largest ... hard on Thanksgiving morning by putting together individual meals via assembly lines and ...
(Date:12/2/2016)... ... December 02, 2016 , ... ‘Tis the season for giving! Today, 20 creative ... National Family Partnership and the Drug Enforcement Administration as part of the National Red ... 10 winning schools who decorated their campuses with this year’s Red Ribbon Week theme: ...
Breaking Medicine News(10 mins):