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Promising lymphoma treatment clears a hurdle

Research

Monoclonal antibody still needs FDA approval

July 28, 1997
Web posted at: 10:59 p.m. EDT (0259 GMT)

From Correspondent Jeff Levine

WASHINGTON (CNN) -- A promising new treatment for non-Hodgkins lymphoma cleared a hurdle Friday and is nearing government approval.

It's called a monoclonal antibody, a chemical agent that seeks out and destroys cancer cells the way a guided missile seeks out and destroys its target.

Among those attesting to its efficacy in treating the immune-system cancer was a doctor who sent her endorsement in a letter to a U.S. Food and Drug Administration advisory panel meeting in Washington.

"As far as she is concerned, it's sort of a miracle of modern science," says Kathryn Adams of the Cure for Lymphoma Foundation. "She feels this drug is her only hope and is a great hope, as she said in her statement, for a long and happy life."

vxtreme CNN's Jeff Levine reports.

The panel also heard about a study of 160 patients with non-Hodgkins lymphoma for whom other treatments had failed.

About half of them got better using a monoclonal antibody called IDEC C2B8, and they stayed healthy for at least nine months.

The letter, the study and other testimony convinced the panel to recommend unanimously that the FDA approve the therapy.

Easier on patients than chemotherapy

Grillo-Lopez

"I felt that the risks are certainly acceptable, and I think it does represent a drug that we can use," said Dr. Carole Miller of the Johns Hopkins Oncology Center and a member of the panel.

The new treatment is easier on patients than chemotherapy or radiation, and its main side effects are flu-like symptoms.

"This antibody is not just active, but it's safe," says Dr. Antonio Grillo-Lopez of IDEC Pharmaceuticals, the company that makes IDEC C2B8. "It is effective, and it provides significant benefits to the patient."

Monoclonal antibodies were heralded as a magic bullet 20 years ago, but they have proved difficult to target at tumor cells only.

If approved, IDEC C2B8 could be the beginning of a new generation of cancer treatments that are tough on tumors and kinder to the patient.

Although the FDA must still make the final decision to approve it, backers of the treatment feel it could be approved and available by the end of the year.

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