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ODAC Recommends Accelerated FDA Approval of Ethyol for Cytoprotection

ODAC Recommends Accelerated FDA Approval of Ethyol for Cytoprotection

ROCKVILLE, Md--The Food and Drug Administration's Oncologic Drugs
Advisory Committee (ODAC) has voted unanimously to recommend accelerated
approval of Ethyol (amifostine injection) as a cytoprotective
agent against cumulative renal toxicities associated with cyclophosphamide
(Cytoxan, Neosar) and cisplatin (Pla-tinol) in patients with advanced
solid tumors of non-germ-cell origin.

Accelerated approval, as opposed to unconditional approval, means
that a new drug may be marketed, but FDA will require additional
studies to determine if the observed effect will lead to clinically
meaningful benefits. If such studies are inconclusive, or if the
company, in this case, U.S. Bioscience, does not perform them,
FDA reserves the right to withdraw the accelerated approval.

Efficacy and Safety

In a randomized, double-blind study, women with ovarian cancer
were divided into two arms: one group received cis-platin and
cyclophosphamide alone and the other group received the two chemotherapeutic
agents with Ethyol. The objective was to determine whether amifostine
reduced cumulative renal toxicity associated with cisplatin, as
measured by creatinine clearance levels.

The toxic effects of cisplatin therapy (neurotoxicity, ototoxicity,
myelosuppression, and neutropenia, as well as nephrotoxicity)
can be permanent and severe. Patients may be left with significant
reduction in renal function, which can preclude their ability
to receive further cisplatin therapy, thus shortening their lives.

Moreover, renal failure, myelosuppression, and neutropenia can
negatively affect the action of other chemotherapeutic agents
such as carboplatin (Paraplatin), methotrexate, and bleomycin.

According to U.S. Bioscience, Ethyol, when given with cisplatin,
reduced nephrotoxicity, ototoxicity, and peripheral neuropathy.
In addition, possible confounding factors, such as preexisting
diabetes, preexisting hypertension, and the existence of other
tumors, had no significant negative effect on the efficacy of
amifostine.

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