PRTODAY / NewswireToday Free press release distribution service network

More news: Research
Written by / Agency / Source: Genentech, Inc.

Check Ads Availability|e-mail Article


Are you the owner of this article?, Turn it PREMIUM with your LOGO instead - and make it 3rd party Ads-Free! within the next hour!

FDA Grants Genentech's Trastuzumab Emtansine (T-DM1) Priority Review for HER2-Positive Metastatic Breast Cancer - Genentech announced that the U.S. Food and Drug Administration (FDA) has accepted the company's Biologics License Application (BLA) for trastuzumab emtansine (T-DM1) and granted Priority Review
FDA Grants Genentech's Trastuzumab Emtansine (T-DM1) Priority Review for HER2-Positive Metastatic Breast Cancer

 

NewswireToday - /newswire/ - South San Francisco, CA, United States, 2012/11/06 - Genentech announced that the U.S. Food and Drug Administration (FDA) has accepted the company's Biologics License Application (BLA) for trastuzumab emtansine (T-DM1) and granted Priority Review. SIX: RO, ROG; OTCQX: RHHB

   
 
Your Banner Ad Here instead - Showing along with ALL Articles covering Research Announcements

Replace these Affiliate Programs at ANYTIME! Your banner here within the next hour. Learn How!


 

Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the U.S. Food and Drug Administration (FDA) has accepted the company's Biologics License Application (BLA) for trastuzumab emtansine (T-DM1) and granted Priority Review. Trastuzumab emtansine's proposed indication is for the treatment of people with HER2-positive, unresectable locally advanced or metastatic breast cancer (mBC) who have received prior treatment with Herceptin® (trastuzumab) and a taxane chemotherapy. The FDA confirmed the action date is February 26, 2013.

"We are very pleased that the FDA has granted trastuzumab emtansine a Priority Review, as we know people with HER2-positive metastatic breast cancer still need new treatment options," said Hal Barron, M.D., chief medical officer and head, Global Product Development.

Roche's Marketing Authorization Application for trastuzumab emtansine for people with HER2-positive mBC has also been accepted for review by the European Medicines Agency (EMA).  

About Trastuzumab Emtansine
Trastuzumab emtansine is an antibody-drug conjugate (ADC) being studied in HER2-positive cancers. It is comprised of the antibody trastuzumab and the chemotherapy DM1 attached together using a stable linker. Trastuzumab emtansine is designed to target and inhibit HER2 signaling and deliver the chemotherapy DM1 directly inside HER2-positive cancer cells. Trastuzumab emtansine binds to HER2-positive cancer cells and is thought to block out-of-control signals that make the cancer grow while also calling on the body's immune system to attack the cancer cells. Once trastuzumab emtansine is taken up by those cancer cells, it is designed to destroy them by releasing the DM1.

Genentech licenses technology for trastuzumab emtansine under an agreement with ImmunoGen, Inc.

Building on the results of trastuzumab emtansine studies to date, there are approximately 25 ADCs in Genentech and Roche's pipeline.

About Breast Cancer
Breast cancer is the most common cancer among women worldwide. According to the American Cancer Society, approximately 229,000 people will be diagnosed with breast cancer, and 40,000 will die from the disease in 2012. In HER2-positive breast cancer, increased quantities of the Human Epidermal growth factor Receptor 2 (HER2) are present on the surface of the tumor cells. This is known as "HER2 positivity" and affects approximately 25 percent of people with breast cancer. HER2-positive cancer is a particularly aggressive form of breast cancer.

About Genentech

Founded more than 30 years ago, Genentech (gene.com) is a leading biotechnology company that discovers, develops, manufactures and commercializes medicines to treat patients with serious or life-threatening medical conditions. The company, a member of the Roche Group, has headquarters in South San Francisco, California.

 
 
Your Banner Ad Here instead - Showing along with ALL Articles covering Research Announcements

Replace these Affiliate Programs at ANYTIME! Your banner here within the next hour. Learn How!


 

Written by / Agency / Source: Genentech, Inc.

 
 

Availability: All Regions (Including Int'l)

 

Traffic Booster: [/] Quick Newswire Today Visibility Checker

 

Distribution / Indexing: [+] / [Company listed above is a registered member of our network. Content made possible by PRZOOM / PRTODAY indexing services]

 
 
# # #
 
 
  Your Banner Ad showing on ALL
Research articles,
CATCH Visitors via Your Competitors Announcements!


FDA Grants Genentech's Trastuzumab Emtansine (T-DM1) Priority Review for HER2-Positive Metastatic Breast Cancer

Company website links NOT available to basic submissions
It is OK to republish and/or LINK any newswire for any legitimate media purpose as long as you name Newswire Today and LINK as the source.
 
  Is this your article?
Activate ALL web links and social stream by Upgrading to Press Release PREMIUM Plan Now!

GenScript |
Publisher Contact: Press Office - Gene.com 
650-225-1000 press[.]gene.com
 
Newswire Today - PRZOOM / PRTODAY disclaims any content contained in this article. If you need/wish to contact the company who published the current release, you will need to contact them - NOT us. Issuers of articles are solely responsible for the accuracy of their content. Our complete disclaimer appears here.
IMPORTANT INFORMATION: Issuance, publication or distribution of this press release in certain jurisdictions could be subject to restrictions. The recipient of this press release is responsible for using this press release and the information herein in accordance with the applicable rules and regulations in the particular jurisdiction. This press release does not constitute an offer or an offering to acquire or subscribe for any Genentech, Inc. securities in any jurisdiction including any other companies listed or named in this release.

Research via RSSAdd NewswireToday - PRZOOM Headline News to FeedBurner
Find who RetweetFollow @NewswireTODAY



Are you the owner of this article?, Turn it PREMIUM with your LOGO instead - and make it 3rd party Ads-Free! within the next hour!


Read Latest Articles From Genentech, Inc. / Company Profile


Read Research Most Recent Related Newswires:

DSM-Niaga Ready for Commercial Scale Production of 100%-recyclable Carpets
DSM Dyneema Introduces Whole New Level of Cut Protection with Black Dyneema® Diamond Technology
DSM Presents Sustainable and Healthy Dairy Solutions At FoodTech 2016
Frost & Sullivan Highlights GENEWIZ's Commitment to Providing Cutting-edge Services in the Life Science Research Services Market
DSM to Present its Latest Advances in Skin Biochemistry At IFSCC Conference
DSM Launches ForTii® Ace Next Generation High Performance Polyamides
DSM Launches New Cultures to Reduce Cheese Ripening Time
DSM Launches New 3C Technology to Reinvigorate Omega-3 Supplements Category
DSM to Highlight its Health and Indulgence Solutions for Baked Goods At IBIE
DSM Welcomes EU Novel Foods Approval for Heart Health Antioxidant
DSM Dyneema Successfully Defends Key Patent Against Competitor Challenge
DSM Expands its Automotive Electronics Portfolio with High-flow Akulon PA66
BD Expands Portfolio of Reproductive and Sexually Transmitted Infections Solutions
BD Announces New Software Release for Pyxis Enterprise Solution
DSM Opens its Asia Pacific Personal Care Technical & Application Center in Shanghai

Boost Your Social Network
& Crowdfunding Campaigns


LIFETIME SOCIAL MEDIA WALL
NewswireToday Celebrates 10 Years in Business


PREMIUM Members


Visit  La Bella Bakery Artisan Bakery Arizona

Visit  JobsWare.com





 
  ©2016 Newswire Today — Limelon Advertising, Co.
Home | About | Advertise/Pricing | Contact | Investors | Privacy/TOS | Sitemap | FRANCAIS
newswire, PR free press releases distribution service magazines engine news alert newsroom press room breaking news public relations articles company news alerts newswiredistribution ezine bizentrepreneur biznewstoday digital business report market search pr firms agencies reports distri-bution today investor relation successful internet entrepreneurs newswire distribution prtoday.com freenewswiredistribution asianewstoday bizwiretoday USA pr UK today - NOT affiliated with PRNewswire as we declined their partnership offer in 2013
 
PRTODAY & NewswireTODAY are NOT affiliated with USA TODAY (usatoday.com)