CN Mobile Logo

Search form


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

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.

Loading comments...

By clicking Accept, you agree to become a member of the UBM Medica Community.