FDA Approves Abraxane

Metastatic Breast Cancer Survivors,

We now have a new weapon. It has been a long time waiting for approval, but Abraxane should be available very soon. I am convinced from the clinicals that this drug will save many lives, and just as important, provide a better "Quality of Life" for those who need the taxanes.

The link to APP,
http://www.appdrugs.com/Press.htm
APP

I hope this makes someones day.
God Bless You All,
ron

Thanks for sharing the info & such a bright ray of hope for all of us. I've been following the development of Abraxane since my dx in May '02 & am so thankful that it is within reach.
Ironically, I'm wrestling w/a single liver met that's popped up after a year of NED. So far back to Taxol for me-I'm very fortunate that I'm still very sensitive to this combo, but I can't wait til Abraxane is approved & part of standard of care.
Currently Abraxane is on "fast track" for FDA approval & is available for "compassionate use" for those who are heavily pre-treated and looking for another option.There's a very specific protocol to follow when applying for compassionate use of a drug pending approval, but certainly worth it for a drug with as much potential as this one.
Hooray, another firearm to add to our arsenal!
Prayers, Faith & Courage!

Thanks, Ron..certainly sounds encouraging!

Thanks Ron: This is what we have been waiting for and very encouraging news. Taxol works great for me but at some point will need to change. This is great timing for many of us. Lots of good infor explained in the link. Blessings, Sandy

[StephN]

Great News!
At San Antonio (Annual Breast Cancer Symposium in early Dec., for those who don't know what this is when we mention "San antonio") I visited a booth in the Exhibition Area. The sign said ABRAXIS.

There were fresh printouts of the "poster session" (this term means a report of data or studies presented at the symposium by researchers). I asked the woman if this had anything to do with "Abraxane." The drug talked about in the poster was by some letter/number name.
She told me that she was not allowed to mention the commercial name of the drug, but since I had brought it up, would talk about it! No one else was near to hear us.

She told me that the drug would very likely get the approval in Jan. and be out with a few short months fairly widely. I told her that my med onc had talked to me about it as a drug he would like to use if necessary in the future since all the Taxol I took had destroyed my deep tendon reflexes, and this one was supposed to be much more gentle in this respect.
She was also glad to meet someone from the patient side of things and get a peek into the clinical angle.

[Lolly]

Thank you Ron, I haven't had the time to do much research lately and this is a welcome bit of news. I know several women at my treatment center who have been on many different combos, and this will defininately be a new option for them. Thanks again!

Were any of our women in the trials?

I'm a bit confused. In one paragraph it touts Abraxane's non-toxicity, in the other it lists its percentages of side effects, all which seem higher than Taxol. Can somebody clear this up for me?

Love and light,

Lisa

Lisa,

One of the main things to notice in those comparisons is the dose of medication, it is about 1 1/2 times higher for Abraxane. If I remember correctly from earlier research the side effects generally dissipated more rapidly with Abraxane than Taxol.

For Cyndi the Taxotere was worse than Taxol and she could not tolerate Herceptin with either. She is on Gemzar + Herceptin now but the last scan only showed stability. We are not excited with stabile, we want shrinkage.

God Bless You,
ron

This new chemo is a great glimmer of hope from God to me. As you know, if you have been following my condition with my lung mets. last week at my oncologist office, I mentioned Abraxane to her since I have exhausted almost all standard chemos for metastatic breast cancer. She told me she couldn;t give it to me because it was not approved it. Then a few days, later, I hear on the news that is approved. I was just so happy. It just seemed at God was there at that moment, letting me hear this. I am writing this because I believe in the power of prayer and in God';s presence. As soon as it is available, my onc. will try it. I hope this is the answer I;ve been praying for. However, though, they did find a brain met also which is a recurring one for which I will get Gamma Knife tomorrow. Please keep me in your prayers. God bless you all!

found this interesting...

[1070] Weekly nanoparticle albumin paclitaxel (Abraxane) results in long-term disease control in patients with taxane-refractory metastatic breast cancer.

OShaughnessy JA, Blum JL, Sandbach JF, Savin M, Fenske E, Hawkins MJ.. Baylor-Charles A. Sammons Cancer Center, Dallas, TX; US Oncology, Houston, TX; Texas Oncology, P.A., Austin, TX; Texas Oncology, P.A, Plano, TX; American BioScience, Inc., Santa Monica, CA

Background: Nanoparticle albumin paclitaxel (Abraxane, ABI-007, ABX) is the first biologically interactive composition exploiting a receptor-mediated (gp60) pathway achieving high intracellular tumor concentrations of the active ingredient, paclitaxel. Weekly administration (3 doses, 1 week of rest) of 100 mg/m2 ABX in 106 patients with taxane-refractory metastatic breast cancer (MBC) was active and well tolerated with no grade (GR) 4 nonhematologic toxicities and 91% of patients maintaining full dose with no dose reduction. In that study, overall response rate was 15% (95% CI: 8%-22%), with a 13% probability of being progression-free at 12 months and a 38% probability of survival at 12 months. Since long-term disease control was achieved with this extremely well-tolerated weekly regimen of ABX, we explored the higher dose of 125 mg/m2 in this same patient population.
Methods: In this Phase II study, patients with taxane-refractory, measurable MBC received ABX 125 mg/m2 weekly IV over 30 minutes on days 1, 8, and 15 on a 28-day cycle without premedication. Patients were considered taxane-refractory if they had progressive MBC while receiving paclitaxel, docetaxel, or both; or if they had relapsed within 12 months of adjuvant taxane.
Results: 75 patients enrolled; 74 received treatment. Median age was 53 (range, 33-74); 94% were postmenopausal; median number of metastatic sites was 4 (range: 1-13); 61% had hormone receptor positive MBC; and median number of prior chemotherapy regimens for metastatic disease was 3 (range: 0-5; n=66). 19 patients (26%) had dose reductions, mostly for sensory neuropathy and neutropenia. Treatment-related (TR) GR 4 toxicities were neutropenia (2 patients), anemia (1), thrombocytopenia (1), infection (1), stomatitis/pharyngitis (1), hypokalemia (1), and thrombosis/embolism (1). TR GR3 toxicities for >1 patient were neutropenia (21 patients), sensory neuropathy (8), fatigue (6), nausea (2), diarrhea (2), anorexia (2), anemia (2), thrombocytopenia (2), febrile neutropenia (2), and muscle weakness (2).
Conclusion: ABX 125 mg/m2 administered weekly is well tolerated for this poor prognosis patient population with taxane-refractory MBC. We have demonstrated that 100 mg/m2 is extremely well tolerated and active in this patient population, and the potential risk-benefit of the higher dose (125 mg/m2) awaits efficacy analysis as the data matures.

Wednesday, December 8, 2004 4:30 PM

Poster Session: Treatment: Chemotherapy -- New Drugs and Formulations (4:30 PM-7:00 PM)