Navigation Links
FDA Gives Nod to New Breast Cancer Drug
Date:7/21/2012

FRIDAY, July 20 (HealthDay News) -- The U.S. Food and Drug Administration on Friday approved the use of the drug Afinitor (everolimus) for use by women with a particular form of advanced breast cancer.

It's the first time that a drug from this class of medications, called mTOR inhibitors, has been approved for this disease, the FDA said. Afinitor is already used to fight advanced kidney and neuroendocrine tumors, as well as a handful of rarer cancers.

The medicine is only approved for use by postmenopausal women battling an advanced form of estrogen-sensitive tumor known as hormone-receptor positive, HER2-negative breast cancer. Even then, Afinitor should only be used after such patients have already experienced a recurrence or progression of the tumor following prior treatment with Femara (letrozole) or Arimidex (anastrozole), the FDA said.

Adding Afinitor -- which has proven effective for other cancers -- to therapy might help these patients, the agency said.

"Afinitor is another example of the value of continuing to study drugs in additional types of cancer after their initial approval," Dr. Richard Pazdur, director of the Office of Hematology and Oncology Products in the FDA's Center for Drug Evaluation and Research, said in an agency news release.

According to the FDA, approval was based on a clinical trial involving 724 postmenopausal women with advanced breast cancer that had spread despite prior treatment with Femara or Arimidex. All of the women also took the standard breast cancer drug Aromasin (exemestane) during the trial.

The trial found that adding in Afinitor boosted average progression-free survival (the time the women lived without any progression of their tumor) by 4.6 months compared to women taking an inactive placebo.

There was a downside to using Afinitor, however: According to the FDA, side effects included rash, fatigue, diarrhea, loss of appetite and mouth ulcers. These effects were more common in women aged 65 or older, so the agency says older patients should be monitored more closely if they take Afinitor.

Dr. Stephanie Bernik, chief of surgical oncology at Lenox Hill Hospital in New York City, commented on Afinitor's approval.

"It is exciting that there continues to be advances in treating breast cancer that are allowing patients to survive longer, even in the face of metastatic disease," Bernik said. "The improved treatment for advanced-stage breast cancer offers women hope that a treatment to completely stabilize, or even eradicate the disease, might be achievable within their lifetime."

The drug is marketed by Novartis Pharmaceuticals Corp., based in East Hanover, N.J.

More information

Find out more about breast cancer at the U.S. National Cancer Institute.

SOURCES: U.S. Food and Drug Administration, news release, July 20, 2012; Stephanie Bernik, M.D., chief, surgical oncology, Lenox Hill Hospital, New York City


'/>"/>
Copyright©2012 ScoutNews,LLC.
All rights reserved  

Related medicine news :

1. U.S. Gives Green Light to Publish Controversial Bird Flu Research
2. Image share project gives patients and physicians anytime, anywhere access to medical images
3. Procedure gives patients with A-fib who cant take blood thinners alternative to reduce stroke
4. UMD team gives drug dropouts a second chance
5. FDA Panel Gives Blessing to New Weight-Loss Drug
6. Amazon Tribe Gives Clues to Heart-Healthy Lifestyles
7. Killer stainless steel: New process gives icon of cleanliness antibacterial coating
8. Aurora Dentist Gives Patients Big Savings With Teeth in a Day Implants
9. OC Firm Gives Back to Young Athletes
10. Study Gives First Evidence That Adult Human Lungs Can Regrow
11. Eliminating the good cholesterol receptor may fight breast cancer
Post Your Comments:
*Name:
*Comment:
*Email:
Related Image:
FDA Gives Nod to New Breast Cancer Drug
(Date:8/20/2017)... ... 2017 , ... State Farm Neighborhood Assist® has named The Southern Maryland ... grant. If the initiative wins, Gals Lead – Dream Queen Foundation’s signature teen girl ... of St. Mary’s, Calvert and Charles Counties. The program could potentially impact nearly 17,500 ...
(Date:8/19/2017)... ... August 19, 2017 , ... ... will feature the Aurum Group in an upcoming episode, slated to air fourth ... Innovations will feature the Aurum Group; a company committed to supporting dentistry using ...
(Date:8/19/2017)... ... August 18, 2017 , ... Paragon and ... database to help the cannabis industry move towards greater legitimacy. By incorporating IOTA’s ... faster technology with lower fees. Paragon will build a fully verifiable database to ...
(Date:8/19/2017)... ... August 19, 2017 , ... The digital health and ... with pending recognition status from the Centers for Disease Control and Prevention (“CDC”) ... and live video conferencing. , The DPP resulted from clinical work conducted ...
(Date:8/19/2017)... ... 2017 , ... Praeclarus Press has launched a new ... the diversity of the breastfeeding mothers, using bright colors and contemporary themes. These ... are also available on tote bags, notepads, smartphone cases, clocks, and travel mugs. ...
Breaking Medicine News(10 mins):
(Date:7/31/2017)... , July 31, 2017  Diplomat Pharmacy, Inc. (NYSE: ... southeast Michigan by Crain,s Detroit ... private and public companies by three-year revenue growth. This year,s ... To view the complete list, visit ... 50 is an incredible triumph," said Phil Hagerman , ...
(Date:7/28/2017)... Inc. ("Hill-Rom") (NYSE: HRC), today announced financial results for ... updated its financial outlook for fiscal 2017. ... quarter, Hill-Rom reported earnings of $0.09 per diluted share ... period. These results reflect after-tax special items, including a ... the non-cash write-down of assets associated with the planned ...
(Date:7/27/2017)... Pharmaceutical Services, Inc. (NYSE: WST ) today ... updated financial guidance for the full-year 2017. ... Reported net sales of $397.6 million, a record ... at constant currency (organic) grew by 3.9%. ... $0.60 in the prior-year quarter. Second-quarter 2017 adjusted diluted ...
Breaking Medicine Technology: