HonCode

Go Back   HER2 Support Group Forums > her2group
Register Gallery FAQ Members List Calendar Search Today's Posts Mark Forums Read

Reply
 
Thread Tools Display Modes
Old 07-21-2017, 09:09 PM   #1
Lani
Senior Member
 
Join Date: Mar 2006
Posts: 4,778
Thumbs up neratinib approved for early breast cancer!

U.S. Food and Drug Administration

FDA News Release

FDA approves new treatment to reduce the risk of breast cancer returning

For Immediate Release

July 17, 2017
Release

Español
The U.S. Food and Drug Administration today approved Nerlynx (neratinib) for the extended adjuvant treatment of early-stage, HER2-positive breast cancer. For patients with this type of cancer, Nerlynx is the first extended adjuvant therapy, a form of therapy that is taken after an initial treatment to further lower the risk of the cancer coming back. Nerlynx is indicated for adult patients who have been previously treated with a regimen that includes the drug trastuzumab.

“HER2-positive breast cancers are aggressive tumors and can spread to other parts of the body, making adjuvant therapy an important part of the treatment plan,” said Richard Pazdur, M.D., director of the FDA’s Oncology Center of Excellence and acting director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research. “Now, these patients have an option after initial treatment that may help keep the cancer from coming back.”

Breast cancer is the most common form of cancer in the United States. The National Cancer Institute (NCI) estimates approximately 252,710 women will be diagnosed with breast cancer this year, and 40,610 will die of the disease. According to the NCI, approximately 15 percent of patients with breast cancer have tumors that are HER2-positive.

Nerlynx is a kinase inhibitor that works by blocking several enzymes that promote cell growth.

The safety and efficacy of Nerlynx were studied in a randomized trial of 2,840 patients with early-stage, HER2-positive breast cancer who completed treatment with trastuzumab within the previous two years. The study measured the amount of time after the start of the trial that it took for the cancer to come back or for death to occur from any cause (invasive, disease-free survival). After two years, 94.2 percent of patients treated with Nerlynx had not experienced cancer recurrence or death compared with 91.9 percent of patients receiving placebo.

Common side effects of Nerlynx include diarrhea, nausea, abdominal pain, fatigue, vomiting, rash, swollen and sore mouth (stomatitis), decreased appetite, muscle spasms, indigestion (dyspepsia), liver damage (AST or ALT enzyme increase), nail disorder, dry skin, abdominal swelling (distention), weight loss and urinary tract infection.

Patients should be given loperamide for the first 56 days of treatment with Nerlynx and as needed thereafter to help manage diarrhea. Additional antidiarrheals, fluids and electrolytes should also be given as clinically indicated to help manage diarrhea. Patients who experience severe side effects, including diarrhea or liver damage (hepatotoxicity), should stop taking Nerlynx. Women who are pregnant or breastfeeding should not take Nerlynx because it may cause harm to a developing fetus or a newborn baby.

The FDA granted the approval of Nerlynx to Puma Biotechnology Inc.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

###
Inquiries

Media

Angela Stark
301-796-0397

Consumers

888-INFO-FDA

Related Information
FDA: Office of Hematology and Oncology Products
FDA: Approved Drugs: Questions and Answers
NCI: Breast Cancer
Follow FDA
Follow @US_FDA on Twitter disclaimer icon
Follow FDA on Facebook disclaimer icon
Follow @FDAmedia on Twitter disclaimer icon
Page Last Updated: 07/18/2017
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English
Accessibility

U.S. Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
1-888-INFO-FDA (1-888-463-6332)
Lani is offline   Reply With Quote
Old 08-03-2017, 10:34 AM   #2
Lani
Senior Member
 
Join Date: Mar 2006
Posts: 4,778
Re: neratinib approved for early breast cancer!

bumping thus up as it seems to have caught noone's attention

Study was for one year's treatment after 1 yr herceptin for early stage her2+ bc
Lani is offline   Reply With Quote
Old 08-04-2017, 01:34 AM   #3
sarah
Senior Member
 
Join Date: Sep 2005
Location: france
Posts: 1,648
Re: neratinib approved for early breast cancer!

Lani, I believe most people read your posts since they are always informative and helpful.
Is it used in cases of recurrence?
thanks
sarah
__________________
sarah is offline   Reply With Quote
Old 08-04-2017, 01:59 AM   #4
melruth
Member
 
Join Date: Jan 2017
Posts: 8
Re: neratinib approved for early breast cancer!

If only Australia followed suit.
melruth is offline   Reply With Quote
Reply

Thread Tools
Display Modes

Posting Rules
You may not post new threads
You may not post replies
You may not post attachments
You may not edit your posts

BB code is On
Smilies are On
[IMG] code is On
HTML code is Off

Forum Jump


All times are GMT -7. The time now is 06:54 AM.


Powered by vBulletin® Version 3.8.7
Copyright ©2000 - 2024, vBulletin Solutions, Inc.
Copyright HER2 Support Group 2007 - 2021
free webpage hit counter