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news.Cephalon has announced that the FDA has approved Treanda for Injection for the treatment of patients with chronic lymphocytic leukemia, a slowly progressing blood and bone marrow disease.
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The Treanda application as a chronic lymphocytic leukemia (CLL) treatment received priority review from the FDA and was approved within six months of the September 2007 submission. Cephalon anticipates that Treanda will be available to physicians and patients as a CLL treatment in the US in April 2008.
In a randomized, international, multicenter, open-label pivotal study of 301 treatment-naive patients with CLL, those who received Treanda had better clinical outcomes compared to patients treated with chlorambucil, an FDA-approved chemotherapy for patients with CLL. Treanda has been granted orphan drug status by the FDA for the treatment of CLL. The orphan drug designation will provide marketing exclusivity in this indication until March 2015.
Lesley Russell, executive vice president, worldwide medical and regulatory operations at Cephalon, said: “Treanda is an important new treatment for patients with chronic lymphocytic leukemia, and this first-cycle approval by FDA represents a significant milestone in the growth of our oncology business.”