Friday, February 22, 2013

Breaking News.........

F.D.A. Approves Breast Cancer Drug  
By ANDREW POLLACK


The Food and Drug Administration on Friday approved a new type of drug that combines the widely used breast cancer medicine Herceptin with a powerful toxin to more effectively kill cancer cells while potentially reducing side effects.

The drug, which will be called Kadcyla but was known as T-DM1 during its development, extended the median survival of women with advanced breast cancer by nearly half a year in a clinical trial.

Genentech, which developed the drug, said it would cost about $9,800 a month, or $94,000 for a typical course of treatment. That is about twice the price of Herceptin itself, which is also made by Genentech, but it is similar to the price of some other new cancer drugs. It is approved for patients with HER2-positive breast cancer, about 20 percent of cases.
Kadcyla is one of the first successful examples of a new class of drug that link toxins to proteins known as monoclonal antibodies. The antibodies latch onto tumors and deliver the toxic payload. Because the toxin is not activated until it reaches the tumor, some side effects are avoided.

Such medicines, known as antibody-drug conjugates, are a hot area for cancer drug developers, with around two dozen such drugs in clinical trials. Another antibody-drug conjugate, Adcetris, developed by Seattle Genetics, was approved in 2011 as a treatment for two rare types of lymphoma.

The linker and toxin used in Kadcyla was developed by ImmunoGen, based in Waltham, Mass., which will receive royalties on sales of the drug. This is the first approved product for ImmunoGen, which has been working on antibody-drug conjugates for three decades.

The main clinical trial leading to approval of Kadcyla involved 991 patients with metastatic breast cancer that was worsening despite treatment with Herceptin and a taxane chemotherapy drug, such as paclitaxel. Half the women were given infusions of Kadcyla and the other half took two pills now commonly used for such patients: Tykerb, also known as lapatinib, and Xeloda, also known as capecitabine.

The patients getting Kadcyla lived a median of 30.9 months, compared with 25.1 months for those getting the two pills. The median time before the disease worsened, a measure known as progression-free survival, was 9.6 months for those getting Kadcyla, compared with 6.4 months for those getting the other drugs.

While having greater efficacy, Kadcyla also had fewer side effects. About 43 percent of patients on Kadcyla had serious side effects compared with 59 percent for those getting the two pills.



Still, the label of Kadcyla has a warning saying the drug can cause liver toxicity, heart toxicity and death. It also can cause serious birth defects or fetal death, so women of childbearing age taking the drug are urged to use contraception.

Herceptin, also known as trastuzumab, binds to a protein on the surface of breast cancer cells called HER2. Since Kadcyla incorporates Herceptin, it too is approved only for the roughly 20 percent of breast cancer cases with an overabundance of HER2.

Kadcyla’s approval is for use after a patient has already failed to respond to Herceptin and a taxane. But Roche, the Swiss company that owns Genentech, is already testing it for use as an initial treatment for metastatic cancer. It is also testing it in combination with Perjeta, another of its drugs for HER2-positive breast cancer, which was approved last June.



Roche executives say they hope that Kadcyla, along with Perjeta, will make Herceptin somewhat obsolete by the time it could face competition from cheaper biosimilars, which are similar to generics. Roche says the United States patent on Herceptin expires in 2019.

Herceptin had global sales of 5.9 billion Swiss francs ($6.3 billion at current exchange rates) in 2012. It was the world’s best-selling drug used only for cancer in 2012.

Genentech tried to win approval for T-DM1 in 2010 as a treatment for breast cancer patients who had run out of options, based on a small trial without a control group. But the F.D.A. turned down the application, angering some patients and patient advocates.


Dancin' the Happy Dance - Keep on Dancin"

Friday, February 15, 2013

A Belated Happy Valentine's Day to you all.

Not much to report.    I had an ECHO on Wednesday to make sure the old ticker is tolerating the chemo treatments.  So far so good.  Next was chemo which besides being stuck twice and it leaving a very colorful black and blue mark was uneventful.

Rumor is that this trial chemo (Hercepton DM-1) I have been on for one year now should be approved by the FDA the end of this month.  There are so many women out there who have been trying to get it that I hope this isn't another false alarm.  I try not to read too much about others experience because it could really start bringing you down when you hear some of it, but I did glance at a few comments from those who have been on it for the past few years and are doing remarkably well.  As I always say your only as good as your last CT scan and I don't want to get too far ahead of myself.

I declare that March 1 is the start of spring.  I'm so tired of being cold.

Until there is more to report.......  Lace up those dancing shoes!

Keep on Dancin"

Friday, February 1, 2013

My Birthday

Today’s my birthday. In the past I wouldn’t have cared much except for the fact that I was growing older. Just another reminder that I couldn’t do the same things I did ten or twenty years ago which would be reinforced every time I looked in the mirror and saw the increase of lines on my face (although no gray hair yet). Evident in my slower pace, falling asleep in the recliner and the fact that I would rather spend the evening watching TV or reading a good book then going out.

But birthdays since my diagnosis have taken on a whole new meaning. In fact I have instituted an event called “birthday week” where I celebrate all week instead of one day. Birthdays now mean I have made one more year then I thought I would. It’s not about celebrating turning a year older, it’s about life. Time I have been given to be with my family and friends. When I was at the hospital last week the nurse who checked me in mentioned we shared the same birthday. My response was something positive (sorry I don’t remember my exact words because her come back to me knocked me for a loop) and she said “just another year closer to dying”. For once I was speechless. Here she was working in a department where all the patients she saw were hoping and praying to see many more birthdays and saw them as positive events in their lives while she looked at the negative of getting older. My guess is that every patient having chemo that day would have gladly traded places with her,

So, did I mention today’s my birthday??? I have been celebrating it all week and will continue to into the weekend. As I look at the cake glowing brightly with one more candle added to it I’ll be thankful that I’ve added yet another year.

Wearing my new birthday Dancin’ shoes and singing Happy Birthday to me!