nun ist es amtlich... Taxotere ist gegen HRPC zugelassen worden. Wenn alles läuft wie geplant, dann wird Satraplatin zunächst die 2nd-line Therapie
Reuters UPDATE - Aventis cancer drug approved in U.S. for new use Wednesday May 19, 3:33 pm ET
(Adds company reaction, details) WASHINGTON, May 19 (Reuters) - The U.S. Food and Drug Administration (News - Websites) on Wednesday approved Aventis's (Paris:AVEP.PA - News; NYSE:AVE - News) drug Taxotere for treating advanced prostate cancer. Aventis, which is being acquired by Sanofi-Synthelabo (Paris:SASY.PA - News), already sells Taxotere for fighting advanced lung and breast cancer.
Taxotere is the first approved drug shown to help extend the lives of men whose prostate cancer does not respond to hormonal treatments, FDA regulators said in a statement.
The FDA approved Taxotere, which is given by injection, for use with prednisone, a steroid.
"This approval for Taxotere provides evidence that our drug can positively impact the lives of men around the world with this disease," Frank Douglas, a vice president for Aventis, said in a statement.
Last year, the drug took in worldwide sales of about $1.56 billion (1.3 billion euros) and held between 60 and 80 percent of global market share, according to Aventis.
Company officials have said approval for additional cancer uses could boost Taxotere sales to more than $3.6 billion (3 billion euros) during the next five years. Overall cancer drug sales should be more than $9.6 billion (8 billion euros) by 2010, officials said.
Prostate cancer is the second biggest cancer killer in men, according to the FDA. This year about 230,900 more men will be diagnosed with the disease and 29,900 will die from it, the American Cancer Society estimates.
A clinical trial of more than 1,000 patients compared Taxotere plus prednisone to another combination, prednisone and the cancer drug mitoxantrone. Patients given the Taxotere combination survived about 2.5 months longer than the other patients, the FDA said.
Yesterday FDA regulators gave Taxotere priority review status for additional use in women with early-stage breast cancer that has spread to the lymph nodes. Aventis also plans to submit it as a treatment for gastric cancer later this year.
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und das schreibt GPC:
While most patients initially respond to hormone therapy, the vast majority eventually relapse, becoming hormone refractory, typically after 18 to 24 months of such treatment. For those patients failing hormone therapy, follow-on treatment involves a limited number of options, including chemotherapy. Currently approved chemotherapeutic agents for prostate cancer include Emcyt® (estramustine phosphate) and NOVANTRONE® (mitoxantrone). Both are approved as palliative treatments. A marketed taxane-based drug, TAXOTERE® (docetaxel), has been submitted for marketing approval in both the U.S. and Europe for use as a first-line chemotherapy treatment in HRPC. There are well-proven synergies between the taxane and platinum families of compounds.
For those patients who fail first-line chemotherapy, there are currently no approved second-line chemotherapy treatment regimens. GPC Biotech is studying satraplatin in combination with prednisone, a synthetic hormone often used to help alleviate pain in advanced cancer patients, as a second-line chemotherapy treatment in HRPC. GPC Biotech believes satraplatin is the only agent currently in a registrational trial for second-line chemotherapy of HRPC.
@ForstFalkenau, wo ist denn dein wichtiger Strahlentherapie-Ansatz hier geblieben? In der Aventis-Taxotere-Meldung wird er jedenfalls nicht erwähnt...
mfg ipollit :-) |