First Approval For Cytogen's Quadramet

6 April 1997

Cytogen Corp has been granted marketing clearance from the US Food andDrug Administration for its radiopharmaceutical Quadramet (samarium Sm 153 lexidronam injection), for the treatment of severe pain associated with metastatic cancers that have spread to bone. This is the first approval for the product and follows review of the company's New Drug Application which was filed in the USA in August 1995.

Dissatisfaction With Analgesics Use of analgesics is often found to be ineffective in the long-term management of bone pain. Cytogen says that according to a report published in the journal Urology, about half of prostate cancer patients were dissatisfied with the pain relief obtained from analgesics.

External radiation therapy is also used in the treatment of painful bone metastases, but it only targets a specific area of bone. This compares to Quadramet, which is able to relieve the pain generated by multiple bone metastases throughout the body.

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