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:1/23/2017)... Consolidated Stability Storage is Leading to CROs ... Outsourcing Market This research service on the global ... and technologies, and provides a snapshot of the key ... and forecasts are provided from 2016 to 2020. ... CAGR of 9.4% till 2020, driven by an explosion ...
(Date:1/23/2017)... -- MouthWatch LLC announced today that its flagship product, the ... intraoral camera on DentalCompare,s list of Top Dental Products ... product was the CollaPlug Absorbable Collagen Wound Dressing . ... popular because it is by far the most economical option ... it doesn,t sacrifice quality imaging." ...
(Date:1/23/2017)... , Jan. 23, 2017 7D Surgical ... clearance from the U.S. Food and Drug Administration ... Canada enabling the North American commercial launch of ... for spine surgery, the 7D Surgical System.  ... 3D optical technologies and machine vision algorithms to ...
Breaking Medicine Technology:
(Date:1/23/2017)... NY (PRWEB) , ... January 23, 2017 , ... ... today that John J. Nelson, a senior accountant at the Firm, will participate in ... Make-A-Wish® Hudson Valley. Over 200 runners will race up 1,576 steps, a vertical distance ...
(Date:1/23/2017)... ... 23, 2017 , ... Wooden and plastic balance boards have been around since at least the ... Board is the first and only balance board to use a patent-pending design featuring ... at the same time as well as skill-level adjustable for all ages and abilities. ...
(Date:1/23/2017)... ... January 23, 2017 , ... ... Crystallization in Process Chemistry by Applying Simple PAT Tools . , ... to isolate and purify the desired product. Chemists now spend more time ...
(Date:1/23/2017)... , ... January 23, 2017 ... ... Foundation (OREF), in partnership with the American Society of Anesthesiologists® (ASA®), the ... (APSF), the American Academy of Orthopaedic Surgeons (AAOS) and the Cigna Foundation, ...
(Date:1/23/2017)... ... ... “Life Under Blankets”: an entrancing story about one woman's travels through the wilderness ... of published author, Kimberly Mitchell, who earned her bachelor’s degree in English education at ... master’s degree in education in the field of curriculum and instruction. Kimberly’s passion for ...
Breaking Medicine News(10 mins):