Create Account | Sign In: Author or Forum

 
 
News  |  Journals  |  Conferences  |  Blogs  |  Articles  |  Forums  |  Twitter    
 

 Headlines:

 

Category: Gynecology | Oncology | Pharmacy | Institutional

Back to Journal Articles

FDA Approves Kadcyla for Late-Stage Breast Cancer

Last Updated: February 22, 2013.

 

Fourth drug approved targeting HER2 protein; slows disease progression, prolongs survival

Share |

Comments: (0)

Tell-a-Friend

 

  Related
 
The U.S. Food and Drug Administration has approved Kadcyla (ado-trastuzumab emtansine), a new treatment for patients with human epidermal growth factor receptor 2-positive, metastatic (late-stage) breast cancer.

FRIDAY, Feb. 22 (HealthDay News) -- The U.S. Food and Drug Administration has approved Kadcyla (ado-trastuzumab emtansine), a new treatment for patients with human epidermal growth factor receptor 2 (HER2)-positive, metastatic (late-stage) breast cancer.

Kadcyla is intended for the treatment of patients who have been previously treated with trastuzumab and taxanes. The safety and effectiveness of Kadcyla were evaluated in a clinical study of 991 patients. Patients treated with Kadcyla had a median progression-free survival of 9.6 months, compared to 6.4 months in patients treated with lapatinib plus capecitabine. The median overall survival was 30.9 and 25.1 months in the two groups, respectively.

Kadcyla carries a boxed warning alerting patients and health care professionals that the drug can cause liver toxicity, heart toxicity, and death. The drug can also cause severe life-threatening birth defects, and pregnancy status should be verified prior to starting Kadcyla, according to the FDA. The most common side effects reported were nausea, fatigue, muscle or joint pain, thrombocytopenia, increased levels of liver enzymes, headache, and constipation.

"Kadcyla is trastuzumab connected to a drug called DM1 that interferes with cancer cell growth," Richard Pazdur, M.D., director of the Office of Hematology and Oncology Products in the FDA's Center for Drug Evaluation and Research, said in a statement. "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."

Kadcyla is marketed by San Francisco-based Genentech, a member of the Roche Group.

More Information

Health News Copyright © 2013 HealthDay. All rights reserved.


Previous: CDC: 2012-2013 Flu Vaccine Not As Effective in Elderly Next: Bariatric Surgery Does Not Appear to Cut Health Care Costs

Reader comments on this article are listed below. Review our comments policy.


Submit your opinion:

Name:

Email:

Location:

URL:

Remember my personal information

Notify me of follow-up comments?

advertisement.gif (61x7 -- 0 bytes)
 

Are you a Doctor, Pharmacist, PA or a Nurse?

Join the Doctors Lounge online medical community

  • Editorial activities: Publish, peer review, edit online articles.

  • Ask a Doctor Teams: Respond to patient questions and discuss challenging presentations with other members.

Doctors Lounge Membership Application

 
     

 advertisement.gif (61x7 -- 0 bytes)

 

 

Useful Sites
MediLexicon
  Tools & Services: Follow DoctorsLounge on Twitter Follow us on Twitter | RSS News | Newsletter | Contact us
Copyright © 2001-2014
Doctors Lounge.
All rights reserved.

Medical Reference:
Diseases | Symptoms
Drugs | Labs | Procedures
Software | Tutorials

Advertising
Links | Humor
Forum Archive
CME | Conferences

Privacy Statement
Terms & Conditions
Editorial Board
About us | Email

This website is certified by Health On the Net Foundation. Click to verify. This site complies with the HONcode standard for trustworthy health information:
verify here.