T-DM1 Approved For Her2 Breast Cancer

Photo courtesy of freedigitalphotos.net and antpkr
Photo courtesy of freedigitalphotos.net and antpkr

T-DM1 Approved For Her2 Breast Cancer
 
Further to my post of August 15, 2012, New Chemotherapy Drug for HER2 – Genentech’s T-DM1, I have an update for you.  The FDA has finally approved T-DM1, now known as the brand-name Kadcyla, for women with HER2+, metastatic breast cancer. The new therapy has been approved for use in patients who have already undergone unsuccessful treatment with a combination of trastuzumab (Herceptin) and a taxane. 
 
An Interesting Method of Delivery

Kadcyla is a conjugate – it combines the drug trastuzumab, better known by the brand name Herceptin, and a powerful chemotherapy drug called DM1.  The trastuzumab portion targets HER2+ cells, then the attached chemotherapeutic molecule – the DM1, which is too toxic to deliver directly into the patient’s bloodstream – is delivered and attacks the cancer cell.   T-DM1 has helped inspire a new generation of antibody + drug conjugates.

Study Results

FDA approval was based on a study known as EMILIA, in which patients with HER2+, metastatic breast cancer who had failed treatment with a combination of trastuzumab and taxane were randomized to ado-trastuzumab emtansine or conventional therapy with lapatinib and capecitabine (Xeloda).  The patients given ado-trastuzumab emtansine resulted in significant improvements in both progression-free survival (9.6 vs 6.4 months) and overall survival (30.9 vs 25.1 months). 

The Down-Side (Why Is There Always A Down-Side?)

This sounds like really great news, however, the drug is not without risk (what else is new?).  The FDA requires labeling on Kadcyla to warn of risks of liver toxicity, reductions in left ventricular ejection fraction for the heart, and death.  In addition, there is risk of severe birth defects, so a woman’s pregnancy status should be determined before starting treatment, the FDA said.  The most common side effects associated with the drug were nausea, fatigue, musculoskeletal pain, thrombocytopenia, elevated liver enzymes, headache, and constipation.

As if all of that weren’t enough, the drug will cost $9,800 a month, or about $94,000 for a 9.5-month course of therapy.  Let’s hope it can keep people alive.

References:

http://www.medpagetoday.com/HematologyOncology/BreastCancer/35052

http://www.asco.org/ASCOv2/Meetings/Abstracts?&vmview=abst_detail_view&confID=114&abstractID=98675

http://chicago2012.asco.org/ASCODailyNews/LBA1.aspx

I send my love to everyone taking this journey right now. If you would like my help with getting through breast cancer in an inspiring and ultra-healthy way, please sign up for my free e-newsletters on the right, or “like” me on Facebook (MarnieClark.com) and I’ll do my utmost to keep you informed and empowered on your healing journey… and beyond.

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