Zevalin nears approval

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FDA Panel Backs Approval of Idec's Zevalin

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WASHINGTON (Reuters Health) Sept 12 - A panel of

expert advisors to the US Food and Drug Administration

backed on Tuesday the approval of a drug with the

unique ability to target and destroy cancer cells much

like a military " smart bomb. "

The FDA's Oncologic Drugs Advisory Committee voted

unanimously in favor of endorsing the approval of Idec

Pharmaceuticals Corp.'s Zevalin (ibritumomab;

tiuxetan), a radioimmunotherapy made by linking

monoclonal antibodies to radioactive isotopes.

Idec is seeking FDA approval for the treatment of

B-cell non-Hodgkin's lymphoma (NHL). If approved by

the agency, Zevalin would be the first

radioimmunotherapy available in the US. The FDA

usually follows its experts' advice, although the

agency is not bound by those recommendations.

To support the endorsement, the company presented data

from five clinical trials that involved about 350

patients. In the primary trial, about 73% of the

patients on Zevalin experienced significant tumor

shrinkage compared with 47% of patients receiving the

monoclonal antibody Rituxan.

The FDA panel's primary concerns were safety and the

relatively small size of the patient population used

to demonstrate the drug's effectiveness, considering

the prevalence of non-Hodgkin's lymphoma.

Although the majority of side effects were mild to

moderate, there was a high rate of patients with low

blood cell counts. The company responded that despite

these low counts, few patients experienced serious

side effects such as infections that required

hospitalization. The company also said that the low

counts might have aided treatment by drawing the drug

into the bone marrow.

Other common side effects included fever, chills,

throat irritation and nausea.

Because of the small patient population, the committee

was reluctant to approve the drug for patients who

have not shown resistance to Rituxan. As a result, the

committee voted to allow for the use of Zevalin in

this patient population only if Idec committed to a

post-marketing study aimed at demonstrating a clinical

benefit beyond tumor shrinkage.

Zevalin clinical investigator Dr. E. Witzig, of

the Mayo Clinic in Rochester, Minnesota, told Reuters

Health that initially the drug would most likely be

used only for the treatment of patients who have

failed chemotherapy or Rituxan alone.

If the FDA should follow its committee's

recommendation, Idec is in a position to launch

Zevalin within 1 to 2 months, Connie Matsui, the

company's senior vice president of planning and

resource development, told Reuters Health. Although

the exact price has yet to be determined, Matsui said

that a course of Zevalin would be approximately the

same price as a course of Rituxan, which costs about

$12,000 per cycle and requires about four cycles of

treatment.

Dr. Witzig said that he expects the drug to be well

received. In the clinical trial, he told Reuters

Health, patients were very receptive to treatment with

Zevalin because it took only 1 week in contrast to the

3 weeks it takes for chemotherapy.

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