Re: [MOL] Navelbine/ Reply [00181] Medicine On Line


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Re: [MOL] Navelbine/ Reply



Welcome to our wonderful forum, a place away from home where you will meed
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lillian

NAVELBINE

FDA has authorized a "treatment IND" for the investigational drug Navelbine
for ambulatory patients with advanced non-small cell lung cancer who are not
candidates for potentially curative regional therapy (for example, surgery
or radiation therapy) or whose disease has spread to other organs of the
body. The following may be used to answer questions.

Surgery and radiation for treatment of three main kinds of non-small cell
lung cancer -- squamous cell carcinoma, adenocarcinoma and large cell
carcinoma -- can cure some patients with localized disease. However,
patients with advanced local or metastatic disease generally cannot be
cured. FDA authorized the treatment IND for Navelbine because clinical
trials showed increased survival time in patients on the drug.

FDA's treatment IND regulations offer a mechanism that allows drug
developers to provide earlier and wider access to promising investigational
therapies for patients with life-threatening or otherwise serious diseases
for which there is no satisfactory alternative treatment.

Two studies have demonstrated that Navelbine injection, used alone or in
combination with cisplatin, was slightly more effective than other
treatments. In one randomized study, patients treated with Navelbine had a
median survival of 30 weeks compared to 22 weeks in patients treated with an
unestablished regimen of other cancer drugs (leucovorin plus fluorouracil
(5FU)).

In a European multicenter, randomized trial, patients with inoperable cancer
given Navelbine plus cisplatin survived a median of 40 weeks compared to 32
weeks for patients given vindesine plus cisplatin and 31 weeks for Navelbine
alone.

The major side effects of Navelbine include neutropenia (a decrease in white
blood cells which increases susceptibility to infection), inflammation or
discomfort at injection site, nausea, vomiting, constipation, and numbness
or pain in fingers and toes.

On Dec. 15, l993, FDA's Oncologic Drugs Advisory Committee recommended
approval of Navelbine for treatment of ambulatory patients with metastatic
non-small cell lung cancer and in combination with cisplatin in ambulatory
patients with advanced disease.

Burroughs Wellcome Co. of Research Triangle Park, N.C., manufacturers the
drug.

-----Original Message-----
From: APatch8111@AOL.COM <APatch8111@AOL.COM>
To: mol-cancer@lists.meds.com <mol-cancer@lists.meds.com>
Date: Thursday, June 03, 1999 4:39 PM
Subject: [MOL] Navelbine


>Please send any and all information you can about Navelbine
>APatch8111@aol.com
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