12:00 AM
Sep 17, 2001
 |  BioCentury  |  Regulation

Understanding accelerated approval

Accelerated approval will be considered when approval "can be reliably based on evidence of the drug's effect on a surrogate endpoint that reasonably suggests clinical benefit or on evidence of the drug's effect on a clinical endpoint other than survival or irreversible morbidity, pending completion of studies to establish and define the degree of clinical benefits to patients."

- Federal Register, Dec. 11, 1992

Last week's recommendations by the FDA's Oncologic Drugs Advisory Committee (ODAC) highlight the flexibility the agency has in granting accelerated approval, a status that is intended to allow it to license products for sale based on convincing but not definitive evidence of efficacy.

In one of its actions, ODAC voted to recommend that Idec Pharmaceuticals Corp.'s Zevalin ibritumomab be granted accelerated approval, rejecting the company's request for full approval because the committee wanted to ensure that studies were conducted to confirm the product's clinical efficacy.

ODAC's Zevalin decision came a day after it voted unanimously to recommend against any form of approval for Matrix Pharmaceutical Inc.'s IntraDose cisplatin/epinephrine injectable gel, even though the company demonstrated improvement on a surrogate marker (see A7).

Contingent approval

Accelerated approval, FDA's framework for allowing products to be marketed before clinical efficacy has been shown, could more appropriately be called "contingent approval." The permission is...

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