FDA Approves Adcetris to Treat Two Types o... (ness of Adcetris in patients with HL was...)

FDA Approves Adcetris to Treat Two Types of Lymphoma

Date:8/19/2011

ness of Adcetris in patients with HL was evaluated in a single clinical trial involving 102 patients. In the single-arm trial, patients were only treated with Adcetris. The study's primary endpoint was objective response rate, the percentage of patients who experienced complete or partial cancer shrinkage or disappearance after treatment. Seventy-three percent of patients achieved either a complete or partial response to the treatment. On average, these patients responded to the therapy for 6.7 months.

The effectiveness of Adcetris in patients with systemic ALCL was evaluated in a single clinical trial in 58 patients. In the single-arm trial, patients were only treated with Adcetris. Similar to the HL trial, the trial's primary endpoint was objective response rate. Of the patients receiving Adcetris for ALCL, 86 percent experienced either a complete or partial response and responded on average for 12.6 months.

The most common side effects experienced with Adcetris were a decrease in infection-fighting white blood cells (neutropenia), nerve damage (peripheral sensory neuropathy), fatigue, nausea, anemia, upper respiratory infection, diarrhea, fever, cough, vomiting, and low blood platelet levels (thrombocytopenia).

Pregnant women should be aware that Adcetris might cause harm to their unborn baby.

The drug is being approved under the FDA's accelerated approval program, which allows the agency to approve a drug to treat a serious disease based on clinical data showing that the drug has an effect on a surrogate endpoint that is reasonably likely to predict a clinical benefit to patients. The program is designed to provide patients with earlier access to promising new drugs, but the company will be required to submit additional clinical information after approval to confirm the drug's clinical benefit.

Adcetris is marketed by Seattle Genetics of Bothell, Wash.

For more information:

FDA: Office of Oncology Drug Pr
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