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FDA Approves Genentech’s Kadcyla (Ado-Trastuzumab Emtansine), the First Antibody-Drug Conjugate...
Business Wire via IBD ^ | 02/22/2013 | NA

Posted on 02/25/2013 12:45:13 PM PST by neverdem

FDA Approves Genentech’s Kadcyla (Ado-Trastuzumab Emtansine), the First Antibody-Drug Conjugate for Treating HER2-Positive Metastatic Breast Cancer

New Personalized Medicine Helped People in Phase III Study Live Longer, Compared to Standard Treatment -- SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)-- Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the U.S. Food and Drug Administration (FDA) has approved Kadcyla™(ado-trastuzumab emtansine or T-DM1) for the treatment of people with HER2-positive metastatic breast cancer (mBC) who have received prior treatment with Herceptin® (trastuzumab) and a taxane chemotherapy. Kadcyla is the fourth medicine from Genentech to receive FDA approval for people with advanced cancers within the past two years.

An antibody-drug conjugate (ADC) is a new kind of targeted cancer medicine that can attach to certain types of cancer cells and deliver chemotherapy directly to them. Kadcyla is the first FDA-approved ADC for treating HER2-positive mBC, an aggressive form of the disease.

“Kadcyla is an antibody-drug conjugate representing a completely new way to treat HER2-positive metastatic breast cancer, and it helped people in the EMILIA study live nearly six months longer,” said Hal Barron, M.D., chief medical officer and head, Global Product Development. “We currently have more than 25 antibody-drug conjugates in our pipeline and hope this promising approach will help us deliver more medicines to fight other cancers in the future.”

Kadcyla is made up of the antibody, trastuzumab, and the chemotherapy, DM1, joined together using a stable linker. Kadcyla combines the mechanisms of action of both trastuzumab and DM1, and it is the first Genentech ADC approved by the FDA. Genentech has studied ADC science for more than a decade and has eight ADCs in Phase I or Phase II studies for different types of cancer...

(Excerpt) Read more at news.investors.com ...


TOPICS: Business/Economy; Culture/Society; Government; News/Current Events
KEYWORDS: adc; breastcancer; cancerdrug; her2positivebreastca; her2positivembc; kadcyla; metastaticbreastca
Forget about Obamacare. The information is out there. How do you put a price on the work that was done to get that information or the worth of another 6 months, more or less, to live? The Chicoms, or somebody else, will be selling their version of it at some point in time. Does that work?
1 posted on 02/25/2013 12:45:23 PM PST by neverdem
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To: neverdem

Personally, I don’t think that $9000/month for an extra 6 months would be worth it for anyone—but the pharmaceutical company. Then again, maybe someone afraid of dying would think it a bargain.


2 posted on 02/25/2013 12:59:28 PM PST by freeangel ( (free speech is only good until someone else doesn't like it)
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To: neverdem

I would advise people to avoid any monoclonal antibody. They are extremely toxic. But do what you have to do.


3 posted on 02/25/2013 12:59:44 PM PST by Doc Savage ("I've shot people I like a lot more,...for a lot less!" Raylan Givins)
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To: Doc Savage

Antibodies are naturally occuring in the human body.


4 posted on 02/25/2013 1:45:44 PM PST by FB2
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To: Doc Savage

Are you a real doctor, or did you just stay at a Holiday Inn Express last night?


5 posted on 02/25/2013 2:37:10 PM PST by muleskinner
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To: Doc Savage

I have the opposite opinion. Monoclonal antibodies saved my wife’s life. She had B-cell mediastinal lymphoma, but has been cancer free for over 5 years after being treated with R-CHOP. The “R” is for rituximab, a monoclonal antibody.


6 posted on 02/25/2013 3:58:05 PM PST by vrwc1
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To: freeangel

In a well functioning market this will eventually become generic and cost a tenth or less of it’s current price. Who are you to decide who gets it?

No offense meant, but the major problem in American health care are third party decision makers be they in government or insurance companies.


7 posted on 02/26/2013 2:56:50 AM PST by 1010RD (First, Do No Harm)
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To: 1010RD

“Who are you to decide who gets it?”

Offense taken. I DID preface the post with the word “personally” which MEANS it wouldn’t be for me. Secondly, there is a history of breast cancer in my family which means I am likely to end up with it, so “personally” means just that. If one is truly afraid to die, then perhaps one is not quite right with the Lord. In which case, I suggest you might want to do that—no offense meant.


8 posted on 02/26/2013 3:21:39 AM PST by freeangel ( (free speech is only good until someone else doesn't like it)
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To: freeangel
I don't take offense easily and am right with God.

That said, you stating “personally” to any post is redundant, unless you're not speaking for yourself.

I am sorry about your family history, but the fact remains these and other interventions start off expensive and drop in price as competitive products reach the market or they go off patent. You or Obamacare bureaucrats shouldn't decide.

When you said, “Personally, I don’t think that $9000/month for an extra 6 months would be worth it for anyone—but the pharmaceutical company. Then again, maybe someone afraid of dying would think it a bargain” did you mean the money or the time? Did you mean that the company providing the service shouldn't be paid? Or that someone afraid of dying, which is quite normal, should be faulted for feeling that way?

It isn't clear.

I am saying the trouble is that people don't pay for their own health care. What that costs isn't your or anyone else’s business.

9 posted on 02/26/2013 3:55:54 AM PST by 1010RD (First, Do No Harm)
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To: 1010RD

“did you mean the money or the time? “

Both. And yes the price will come down after the patent expires—maybe as much as ONLY $2000/mo. It is MY business because I am at risk. I also think there are a lot of other drugs out there that will extend life for 6 months at a fraction of the cost. An example of rip-off drugs: Lucentis for macular degeneration is priced around $2000 a pop given about every 5 wks to 3 mos. Now, Avastin, which is $150 a pop works just as well—but really isn’t marketed for that use. Who is getting screwed? The patient by the pharmaceutical company that markets the more expensive drug, or the pharmaceutical company that the patient declines to use because the drug is more expensive than the one being used “off market” and thus is not paid for the “service” it provides? And who, in the FDA, is getting paid to prevent the less expensive drug from being approved? What I am ultimately saying is that patients need to do their research VERY carefully and make informed decisions. They do not need to jump at every “hope” that may be marketed by researchers,docs and pharmaceutical companies without first considering a cost/benefit angle.


10 posted on 02/26/2013 4:37:45 AM PST by freeangel ( (free speech is only good until someone else doesn't like it)
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To: freeangel

Good and correct. Thanks for the clarification.


11 posted on 02/26/2013 4:53:53 AM PST by 1010RD (First, Do No Harm)
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