Paxene Wins ODAC Backing for Use In AIDS-Associated Kaposi’s Sarcoma

BETHESDA, Md—For the second time in as many meetings, the Oncologic Drugs Advisory Committee (ODAC) has recommended that the FDA approve a paclitaxel-based drug for the treatment of AIDS-related Kaposi’s sarcoma (KS).

The panel voted unanimously in favor of the approval of Baker-Norton Pharmaceuticals’ Paxene (paclitaxel) for use after failure of first-line or subsequent systemic chemotherapy for the treatment of advanced AIDS-related KS.

In June, ODAC members urged the approval of Bristol-Myers Squibb’s Taxol for Injection Concentrate for the second-line treatment of Kaposi’s sarcoma in AIDS patients. The FDA has since approved the new indication for Bristol-Myers Squibb’s Taxol as recommended.

In support of Paxene, Baker-Norton , a wholly owned subsidiary of IVAX Corporation, presented a study involving 89 HIV patients with KS who had previously undergone chemotherapy.

The company’s analysis and that of the FDA review team generally agreed on the response rate. Baker-Norton claimed two complete responses and 39 partial responses (44%). The FDA credited no complete responses and 37 partial responses (42%).

However, while the company listed 29 patents (33%) with stable disease and only five with progressive disease (6%), the FDA analysis concluded that only 16 patients (18%) remained stable and 22 (25%) progressed. Both analyses listed 14 patients (16%) as “not evaluable.”

The FDA reported that median duration of response was 128 days; median time to response was 34 days; and median time to progression was 164 days.

Data presented at the meeting showed that among the 89 patients, six had improvements in their facial lesions while 19 did not; one had improvement in his foot lesions while 12 did not; and six had improvement in lower extremity lymphedema while 45 did not.

On the basis of clinical benefit and quality-of-life assessments, as well as the cutaneous tumor response rate, the panel voted unanimously that Paxene showed patient benefit. Finally, and again in 11-to-0 votes, the ODAC members agreed that Paxene’s safety was acceptable “in view of the trial’s efficacy results and results available with alternative therapy” and that the FDA should approve it.