Cephalon ( CEPH) on Friday received a second approval from the Food and Drug Administration for its cancer drug Treanda, this time as a treatment for patients with non-Hodgkins lymphoma (NHL). Treanda is the only new cancer drug to receive FDA approval this year. In March, regulators approved the drug as a treatment for chronic lymphocytic leukemia (CLL), a cancer of the blood and bone marrow. Friday's approval extends Treanda's use to the indolent, or slow-growing, form of NHL, a cancer of the immune system. Cephalon views Treanda as the backbone of a new cancer-drug business, which, along with its pain franchise, shifts the growth drivers for the company away from its maturing central nervous system drugs like Provigil. Treanda's sales in the third quarter totaled $25 million, just a fraction of Cephalon's $490 million in total revenue for the quarter. With two approvals now under its belt, however, Treanda's peak annual sales could reach $400 million to $500 million, according to various analyst estimates.
Friday, the FDA approved Treanda for use in indolent NHL patients whose cancer continued to grow after treatment with Genentech's ( DNA) Rituxan and chemotherapy. The approval was based on a pivotal study of 100 patients, all treated with Treanda given by injection, which showed a 75% response rate with a median duration of response of just over nine months. Indolent NHL is a far larger commercial market for Treanda than CLL. Genentech's Rituxan is the dominant treatment in indolent NHL, contributing the lion's share of the drug's $2.3 billion in sales last year. Rituxan is such a big NHL drug, in part, because patients can be retreated with the drug once the cancer starts growing again. While patients can be retreated with Rituxan for years, the efficacy of Rituxan decreases with every retreatment and the drug eventually stops working.