logo
  Join        Login             Stock Quote

FDA Approves Roche's Kadcyla For Late-Stage Breast Cancer

 February 22, 2013 11:08 AM
 


(By Balachander) The U.S. Food and Drug Administration (FDA) has approved Roche Holding AG's Kadcyla, a treatment for HER2-positive metastatic breast cancer.

Roche's Genentech licenses technology for Kadcyla under an agreement with Immunogen Inc. (NASDAQ: IMGN), which will receive a $10.5 million milestone payment following the FDA approval.

Kadcyla is the fourth medicine from Genentech to receive clearance from the U.S. health regulators for people with advanced cancers within the past two years.

Kadcyla works by connecting trastuzumab - another anti-HER2 therapy - to a drug called DM1 that interferes with cancer cell growth, the FDA said.

[Related -Analysts' Rating Changes: AAPL, AKS, BBBY, FB, IMGN, LIFE, RIG]

The FDA said "Kadcyla delivers the drug to the cancer site to shrink the tumor, slow disease progression and prolong survival. It is the fourth approved drug that targets the HER2 protein."

The drug could generate annual peak sales of $1.9 billion, Reuters reported quoting analysts at Jefferies.

Breast cancer is the second leading cause of cancer-related death among women. An estimated 232,340 women will be diagnosed with breast cancer, and 39,620 will die from the disease in 2013, according to the National Cancer Institute. Around 20 percent of breast cancers have increased amounts of the HER2 protein.

Kadcyla is being approved with a boxed Warning that the drug can cause liver toxicity, heart toxicity and death. The drug can also cause severe life-threatening birth defects.

[Related -Nasdaq Outperforms In Mixed Session]

The most common side effects reported in patients treated with Kadcyla were nausea, fatigue, pain in the muscles or joints, low levels of platelets in the blood, increased levels of liver enzymes, headache, and constipation.

Immunogen said its TAP technology uses a tumor-targeting monoclonal antibody to deliver one of its highly potent cancer-killing agents specifically to tumor cells.

IMGN shares jumped 4.62 percent to trade at $14.96 on Friday.

iOnTheMarket Premium
Advertisement

Advertisement


Post Comment -- Login is required to post message
Name:  
Alert for new comments:
Your email:
Your Website:
Title:
Comments:
 

rss feed

Latest Stories

article imageLevel 3 Communications, Inc. (LVLT): A Good Time To Buy Says Macquarie

On a day Wall Street is struggling to advance, Level 3 Communications, Inc. (NYSE:LVLT) is having no such read on...

article imageAbercrombie & Fitch Co. (ANF) Q2 Earnings Preview: The Unkind Quarter

Abercrombie & Fitch Co. (NYSE:ANF) will be holding its second quarter 2014 earnings conference call for all read on...

article imageWorkday Inc. (WDAY) Q2 Earnings Preview: Built In Surprise

Workday Inc. (NYSE:WDAY) plans to announce its fiscal 2015 second quarter results after market close on read on...

article imageArcelorMittal SA (ADR)(MT): Steel Stocks about to Get Red Hot

For the second consecutive day, a major broker upgraded a steel company by advancing their recommendation read on...

Advertisement
Popular Articles

Advertisement
Daily Sector Scan
Partner Center

Related Articles:

Volatile Session Ends Narrowly Mixed
More Articles on: Medical , Europe



Fundamental data is provided by Zacks Investment Research, and Commentary, news and Press Releases provided by YellowBrix and Quotemedia.
All information provided "as is" for informational purposes only, not intended for trading purposes or advice. iStockAnalyst.com is not an investment adviser and does not provide, endorse or review any information or data contained herein.
The blog articles are opinions by respective blogger. By using this site you are agreeing to terms and conditions posted on respective bloggers' website.
The postings/comments on the site may or may not be from reliable sources. Neither iStockAnalyst nor any of its independent providers is liable for any informational errors, incompleteness, or delays, or for any actions taken in reliance on information contained herein. You are solely responsible for the investment decisions made by you and the consequences resulting therefrom. By accessing the iStockAnalyst.com site, you agree not to redistribute the information found therein.
The sector scan is based on 15-30 minutes delayed data. The Pattern scan is based on EOD data.