Home » Drug Information » FDA Approved Drugs » 1998
Medical Areas: Oncology
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The following drug information is obtained from various newswires, published
medical journal articles, and medical conference presentations.
Company: Anthra Pharmaceuticals
Approval Status: Approved October 1998
Treatment Area: Oncology
Valstar (Valrubicin) is used as an intravesical therapy of
BCG-refractory carcinoma in situ (CIS) of the urinary bladder in
patients for whom immediate cystectomy would be associated with
unacceptable morbidity or mortality.
Irritable bladder symptoms.
Valstar is contraindicated in patients with known
hypersensitivity to anthracyclines or Cremophor7 EL
Patients with concurrent urinary tract infections should not
Valstar should not be administered to a patient with a small
bladder capacity, i.e., unable to tolerate a 75 mL
Patients should be informed that Valstar has been shown to
induce complete responses in only about 1 in 5 patients, and that
delaying cystectomy could lead to development of metastatic bladder
cancer, which is lethal. They should discuss with their physician
the relative risk of cystectomy versus the risk of metastatic
bladder cancer and be aware that the risk increases the longer
cystectomy is delayed in the presence of persisting CIS.
Mechanism of Action
Valrubicin is an anthracycline that affects a variety of
inter-related biological functions, most of which involve nucleic
acid metabolism. It readily penetrates into cells, where it
inhibits the incorporation of nucleosides into nucleic acids,
causes extensive chromosomal damage, and arrests cell cycle in G2.
Although valrubicin does not bind strongly to DNA, a principal
mechanism of its action, mediated by valrubicin metabolites, is
interference with the normal DNA breaking-resealing action of DNA