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lizws

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Bristol-Myers Cancer Drug

Wins Approval From FDA

<>

By JENNIFER CORBETT DOOREN
October 16, 2007 5:58 p.m.

WASHINGTON -- The Food and Drug Administration on Tuesday approved a new chemotherapy drug to treat advanced breast cancer, an agency spokesman said.

The drug, Ixempra, Bristol-Myers Squibb Co. was approved for use in women who have failed treatment on three other types of chemotherapy. The drug was also approved for use with another chemotherapy drug, capecitabine, sold under the brand name Xeloda by Roche Holding AG, in women with breast cancer that has spread to other parts of the body.

Ixempra was granted priority review status, which cuts four months off the standard 10-month drug review time and is reserved for treatments the FDA deems an advance over existing therapies on the market.

Ixempra targets a protein called tubulin, which is needed to help cells proliferate, and is designed to stop cancer cells from growing. The drug, also known by its generic name ixabepilone, falls into a new class of drugs known as epothilones.

Shares of Bristol-Myers, which were down 49 cents at $29.24 during Tuesday's regular session, rose to $29.95 in after-hours activity.

Over the past decade many drug companies have focused on developing so-called targeted therapies that either attack proteins involved with cancer growth or choke off a tumor's blood supply. Robert LaCaze, Bristol's vice president of oncology marketing, noted that chemotherapy is still the "backbone" of most cancer treatment, and he said new chemotherapy drugs are needed to treat cancer that's stopped responding to other types of chemotherapy drugs.

While chemotherapy, which is typically administered by an injection or an infusion, kills cancer cells, it also kills healthy cells and has side effects such as fatigue and neuropathy or the feeling of pins and needles or numbness in hands and feet.

One of the main clinical studies of Ixempra looked at the drug in combination with Xeloda in patients with breast cancer who had previously been treated with other chemotherapies.

About half of the 752 patients received Xeloda plus Ixempra, while half received Xeloda alone. Progression-free survival, which measures time until patient death or tumor growth, was 5.8 months among those taking Ixempra plus Xeloda, versus 4.2 months in the Xeloda-only group. There was a greater rate of tumor response in the Ixempra group. About 23% of patients in the Ixempra reported neuropathy while no patients receiving Xeloda alone had neuropathy.

Bristol-Myers is also studying Ixempra for use in treating earlier-stage breast cancer, non-small cell lung, ovarian, prostate, pancreatic and renal cancers.

 

 

WALL STREET JOURNAL


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Reply with quote  #2 
That is cool Liz!
Now how in heck do we pronounce it???


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Reply with quote  #3 
I read that yesterday also,,,wonderful news.

Amy
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Reply with quote  #4 
Icks. 
Odd, was asking about this new drug today, and like so many other Cisplatin, Xeloda, Abraxane, and the new forms of Anthrocyclines and Cytoxins; they are reserved for Mets or Patients who have not responded to "conservative standard treatments", even if they have the potential to halt cancer cells in it's tracks; not enough research, continued clinical trials, and the long term side effects keeps the early stage forms from using the Epilithilone and Moleculars drugs now assigned only to special circumstances. 
 
My mother was one...she was given Platinum and several other chemotherapy drugs for Inlammatory Breast Cancer.  Sure wish there was a way to improve the current practice used to test the possibly hopeful drugs.  My mother lived three years, died, reall from pneumonia due to a compromised immune systems brought on by the "overdose" of Platinum. 
 
They originally said she would live maybe six weeks to six months if she was lucky.
 
Who knows how long she had this cancer before it was discovered.  So, perhaps her longterm survivai is/was longer than they knew. 
 
Wish I was scientist, research specialist or pathologist.  Mighty interesting information!
 
Thanks Lizws!
 
Love, prayers, hope, (((zillions of gentle hugs)))
 
Indi
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Reply with quote  #5 
I asked my onc about this new drug and this was her take on it. She was part of the clinical trial.
She said it is a very hard drug..meaning it is hard on your body and it is reserved for people with mets  that have exhausted all the other chemos first. It's a fourth generation or fourth line chemo treatment.
So needless to say, she didn't recommend it for me.

As a reference- Xeloda is considered a second generation or second line chemo.
edge

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Reply with quote  #6 
Lori:
 
There is some confusion here, and these statements would be in error, moreover confusing the generation of an agent with it's sequence of deployment, it's "line" - the generation of an agent (when it was developed in a comparative broad timeline against other agents) and line (when an agent can be prescribed, namely after which other previous therapies) have nothing whatever to do with each other. Let me try to clarify.

Ixabepilone (Ixempra) is a fourth generation agent - and capecitabine is a third generation, not second generation, agent - but it is incorrect to say that Ixempra is reserved for patents with MBC (metastatic breast cancer) who have exhausted all other chemotherapies first: the FDA approved the doublet (combination) regimen of Ixempra + capecitabine (Xeloda) for MBC patients who have progressed or failed on, or are refractory to just previous anthracycline and taxane chemotherapy. So if a patient were first treated with AC ---> Paclitaxel (Taxol), or with TAC, but advanced, failed, or proved resistant on one of these combination anthracycline + taxane regimens, then Ixempra + Xeloda is deployable by FDA approval. If this were after the triple combination of TAC (three agents), it would be first or second-line, not fourth line, therapy - it follows therapy with the TAC (triple agent) regimen; we do not count each agent, as this was a combination regimen (AC ---> taxane and TAC are the most commonly deployed regimens in these cases, so I use these as examples). Whether it is first line or second line depends on whether the prior anthracycline-taxane therapy were for primary non-metastatic disease and the patient has since developed metastatic involvement, for which the Ixempra + Xeloda is being tried, in which case it is first line therapy for the metastases. If on the other hand, the patient was already metastatic, and the previous anthracycline-taxane therapy was for the metastatic disease itself, then the Ixempra + Xeloda would be considered second line therapy (not fourth-line therapy); one only has to progress or fail on, or be refractory to, two chemotherapies, anthracyclines and taxanes, to be approved for Ixempra + Xeloda (three if one goes for Ixempra monotherapy, used after failure on both previous anthracycline-taxane therapy and previous Xeloda therapy). In contrast, gemcitabine (Gemzar) is approved in combination with paclitaxel (Taxol), that is Gemzar + Taxol, for the first-line treatment of patients with metastatic breast cancer after failure of prior anthracycline-containing adjuvant chemotherapy.

As to tolerability, Gemzar does indeed have few severe adverse events, but treatment-related adverse events for Ixempra were found to be manageable, and treatment was judged to be well tolerated by patients, as concluded by the study authors themselves in the first of the two studies (Edith Perez and colleagues) upon which FDA approval was based, and this was similarly true even for the Ixempra + Xeloda combination regimen, as concluded in the second FDA-approving study (Linda Vahdat et al.). In an recent interview with the author, Linda Vahdat, Director of Breast Cancer Research at the New York-Presbyterian Hospital (Weill Cornell Medical College), she observed that "Ixabepilone as a single agent has a toxicity profile somewhat between paclitaxel and docetaxel in that peripheral neuropathy can be a prominent side effect. We manage the side effects of ixabepilone much the same way they are handled for paclitaxel or docetaxel, namely with dose reductions and dose delays". And as I noted, Ixempra is the first agent to show a survival benefit in triple negative disease for patients who have progressed or failed on, or proved refractory to, these previous chemotherapies.

Note I am not here pressing the matter of the choice of therapy, something that of course you in consultation with your oncologist decide; I have already stated my own opinion elsewhere in these forums when requested to do so. I am here only clarifying the facts - and they are, as stated above, not in dispute and reflect the official FDA approval and use standards - about use ("line") versus generation, and about the acceptable and manageable tolerability of Ixempra-based regimens and Ixempra itself.


Constantine Kaniklidis
Breast Cancer Watch
edge@evidencewatch.com

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Angel
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Reply with quote  #7 

Thanks....just stating how it was explained to me by my oncologist.

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Reply with quote  #8 
Beautiful Dream...Constantine,
and to softly breezes sweeping a Rainforest's Ferne,
 
Thank you for clarifying this information.
 
Did you happen to see the Total Eclipse last night?
 
There is something mystical in regards to Ixempra and the unknown and what is and what is not known.
 
Time...the eclipse...the moon speaks.
 
When someone passes, I always make notes and draw pictures of the faces on the moon; I don't know what it actually signals, yet I know there is hope. 
 
I hope the flag has disintegrated and the moon will always tell us it's story...beauty, life, eternity, genius, universal love; all wrapped in a galaxy filled with black holes and shining stars.
 
This new drug...sounds frightening.  I was prescribed Lyrica; filled it, and talked to some science, med Friends began the usual research routine...nasty stuff. 
 
I am tired.  My body hurts from the chemo and radiation.
What is what in the ambiguity of toxic drugs, the limitations and the unknown?
 
I hope you witnessed the Total Eclipse.
 
It tells all.
 
Indi
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Drawing on the face of the moon is a primitive creative act. 

 

And the moon (celene (or selene) in Greek) has a special place in the world of Greek and Cyprian lore: the moon's Goddess is Artemis (Roman, Diana) who not only is the Goddess of the Hunt and Goddess of the Forest, Woman-Warrioress, but also the Goddess of Light and the Protector of the Vulnerable and the Suffering, and it is for that reason that some creative folks at Johns Hopkins named their unique and highly intelligent - but virtually unknown - breast cancer newsletter, Artemis (click to read). 

 

Greeks know all eclipses and darkness pass –

Artemis is in the sky, with her "curving line of imperturbable serenity" * 

 

* Thomas Hardy, At a Lunar Eclipse, 1928



I know Indi is back.

Constantine

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Reply with quote  #10 
Thank you Constantine for this "cultural break"... we need those, too... I grew up with Greek mythology (since I was studying "ancient" Greek in middle-school and high-school) and loved these stories... still do.

Thanks also for the link: very interesting indeed...

Kali spera sas,

Catherine
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Reply with quote  #11 

Man in the Moon, gliding across the horizon, and Mighty Catherine whose shimmering, glorious wings cause my heart to flutter and soar with  enchanted silver wings and minds, articulating ideals, confidence and to all of the  beautiful souls I am honored to connect with here:
 
Thank you.
 
Love to all, prayers, and (((gentle hugs))),
 
Indi
 
Funny about life's mysteries...Dan Fogleberg recently passed away from cancer...while writing and reading this post, a concert on PBS is being broadcasted on t.v.  I never watch television, and only turned it on for "noise".
I have always loved his music, and was very sad when he left this world.  My sister knew how I adored his music.  Connections, spiritual dimensions, hope, love, and the eternal quest of heart, mind, existance, happiness, suffering...it is an amazing wonder; life, death, all before, between, and thereafter...

Kali spera sas?  I know not what the interpretation means in English, however, my best friend is Greek, and my neice is currently (possibly engaged, almost) with a beautiful man she met this summer when visiting Greece.  He is involved with Medical Research...wouldn't it be too much if it was a friend of Constantine's?  She is in the early romantic "young first love", so I don't know the details.   Perhaps I will find out more when I ask her about "Kali spera sas".  Tee hee...

 

Love you all so much!
 
 

 


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Reply with quote  #12 

Indi:

Your niece possibly with a Greek medical researcher? Can heaven be closer to Earth? Are we poor medical researchers finally coming out of the shadows and into the spotlight?

You may not be aware that the Academy Awards tomorrow will have for the first time a new award category,
Best New Medical Researcher in a Supporting Role (one salacious entry will be the non-subtitled foreign animated black-and-white film, shot soley by a hand-held camera, the mesmerizing "Hedgehog Signal Transduction in Malignant Human Mammary Stem Cells"; who could forget? (the X-rated version is still causing sporadic riots)), to be aired in the coveted slot immediately following an Abreva herpes commercial), and just after the award for Best Assistant Gaffer in a Supporting Role to Second Key-Grip. The tension will be horrific.

So let the general public ogle the hunks and hunkesses, I know what the faithful readers of this forum will be glued to!

Johnny Depp, prepare for obscurity.

P.S. Indi: A couple of my many favorite Dan Fogelberg lines:

Beyond the edge way beyond the limit

Out on the edge it's another story

[D. Fogelberg, Beyond the Edge, 1987]

Kali spera sas = Good Evening

P.S. Catherine: Thanks, always good to hear from you (and in Greek).

Constantine


Constantine Kaniklidis
Breast Cancer Watch
edge@evidencewatch.com

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Reply with quote  #13 
...and to top it all, Constantine, you have a terrific sense of humour and write not only efficiently but beautifully... Thanks for this very funny post... and should I say "kali nikhta" (it's getting late, so "good night" would now be more in order...)...
Catherine
ps: I can't believe that at one point in my life I knew Theodorakis & Farandouri's songs by heart, and could read Kazantzakis in the original... (not to mention the classics)... not enough room in my little head to keep all that in "working" order... some day...
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Reply with quote  #14 
There was a time, many moons ago that I used to attend the Oscars and Emmy's because of  a relationship with the sponsor of the events.
I found the stars to be ordinary people, with a few exceptions. But this was back when stars were stars, at least to me.
However, I would trade all those awards ceremonies in to attend the one where the Medical Researcher is the contender, dare I say it? Frontrunner??
I will never forget the classic monologue on gene assays delivered by Spencer Tracy at the end of  Guess Whose DNA is Coming to Dinner.


Constantine, what WOULD we do without you??????


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A lovely video about a Hedgehog who was also a Russian Researcher, and able to cure his friends with raspberries...

Sweet little hedgehog...

click on  and take a break, sweet Constantine!

Have a lovely day.

Indi

Don't know if it won an Acadamy Award...never watch t.v.
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Reply with quote  #16 
Indi... such a cute "multfilm" (from the Soviet era...)... they had quite a production in those days... adorable story (I adore hedgehogs)... and they still "cure" everything with raspberry jam (uncooked, though, just a paste made of berries and sugar) from the common cold to any aches and pains... the equivalent of chicken soup here. They know the goodness of raspberries in those cold climates... and Russian language is so smooth...

Thank you for spending your "unsleepy" hours to the gathering of lovely videos...

Catherine
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Reply with quote  #17 
Indi- I wonder if Gertrude needs to meet a Hedgehog?
Where have we last left our heroine????


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Reply with quote  #18 

i am starting Ixempra this coming Wednesday, May 28th. Does anyone have any ideas what to expect from it? I have been hearing mixed reports about the SEs. (Mostly bad, sorry to say)

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