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| |  FDA Grants Priority Review To Doxil For Refactory Ovarian Cancer PALO ALTO, CA -- April 15, 1999 -- The United States Food and Drug Administration has accepted for priority review a supplemental new drug application (sNDA) for Alza Corp.’s Doxil(R) (doxorubicin HCl liposome injection) in the treatment of refractory ovarian cancer. Doxil has been granted orphan drug status for ovarian cancer, which provides for seven years of marketing exclusivity. The sNDA seeks marketing approval for the use of Doxil in the treatment of patients with metastatic carcinoma of the ovary, who are refractory to both paclitaxel- and platinum-based chemotherapy regimens and who may be refractory to topotecan therapy. Refractory is defined as a patient having progressive disease while on treatment, or within six months of completing treatment. The December 1998 submission was supported by two Phase II clinical trials. The FDA has agreed that there is an unmet medical need for patients addressed by this sNDA, and as such, the agency would evaluate the supplemental application under accelerated approval regulations. Applications targeted for accelerated approval typically receive a priority review. The FDA goal for review and action on priority review applications is six months from the date of submission. Doxil is currently indicated for treatment of Kaposi's sarcoma (KS) in patients with disease that has progressed following first-line chemotherapy, or in patients who are intolerant to such therapy.
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