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Biotech / Medical : CLTR COULTER PHARMACEUTICAL
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To: kendall harmon who wrote (286)8/31/1999 12:44:00 AM
From: Bharat H. Barai  Read Replies (2) of 666
 
Most people forget that once a drug is approved for one indication, the physicians can legally use the drug for any other indication and in a different dose, as long as there is scientific basis to support such use.

Rituxan is used lot more for indications other than in package insert. Bexaar may seek approval for a very limited indication, to get thru quickly. Then let MDs use it for other indications.

All pharmaceutical companies play this legal game to avoid Billions of Dollars in additional FDA related expenses. Lilly got Gemcitabine approved for Pancreatic Cancer, the drug is used mostly for Lung Cancer, Lymphomas etc. BMY got Etoposide approved for refractory Testicular Cancer and the drug is used 99% for other indications. Taxol was originally approved for refractory Ovarian Cancer and most use today is in Breast and Lung Cancers. So Off label uses are norms rather than exception in Oncology.

Bexaar appears to be far more effective than Rituxan, needs only 3 doses but will probably be administered in Hospital, because of radio active compound handling. Rituxan is used today more and more as 1st line therapy, with chemotherapy for low grade as well as high grade lymphomas. Some have started using Rituxan for refractory Hodgkin's also. If the response rates are as good as in pivotal trial, Bexaar will be a Drug Royale for treatment of Lymphomas.

Bharat H. Barai MD
Hematologist-Oncologist
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