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FDA APPROVES TWO NEW INDICATIONS FOR RITUXAN...
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FDA APPROVES TWO NEW INDICATIONS FOR RITUXANî (RITUXIMAB) IN PATIENTS WITH NON-HODGKINâÂÂS LYMPHOMA
The U.S. Food and Drug Administration (FDA) has approved two additional uses for Rituxan for patients with CD20-positive, B-cell non-Hodgkin's lymphoma (NHL).
One new indication for Rituxan is for first-line treatment of previously untreated patients with follicular NHL in combination with CVP (cyclophosphamide, vincristine and prednisolone) chemotherapy.
The second new indication is for the treatment of low-grade NHL in patients with stable disease or who achieve a partial or complete response following first-line treatment with CVP chemotherapy.
NHL is the sixth most fatal cancer in the U.S. and an estimated 360,000 Americans have NHL - more than 58,000 new cases are diagnosed annually. About 30 percent of those patients diagnosed have a slow-growing, but incurable (low-grade) form of the disease -- the most common type is called follicular lymphoma. Relapse is common in these patients, making the goal of treatment to delay disease progression for as long as possible.
The second new Rituxan indication represents a new approach to the treatment of NHL, enabling doctors to treat patients front-line with Rituxan, already one of the standard therapies for NHL, on an extended basis following a good response to upfront CVP chemotherapy. Studies showed that this treatment approach helped reduce the risk of disease progression, relapse or death in certain NHL patients.
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