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Cephalon's Treanda OK'd for Second Cancer Indication
(BioWorld Today Via Acquire Media NewsEdge) The FDA Friday granted approval to Cephalon Inc. to market Treanda (bendamustine hydrochloride), a purine analogue/alkylator hybrid, as a treatment for a certain type of non-Hodgkin's lymphoma (NHL).
The decision comes seven months after Treanda was cleared as a treatment for chronic lymphocytic leukemia (CLL), which makes the medication the only new drug this year to gain approval for two cancer indications. (See BioWorld Today, March 21, 2008.)
The approval granted Friday was for indolent NHL, a slow-growing form of the disease in which patients are prone to multiple relapses after initial therapy. The disease affects about 30,000 people annually in the U.S.
Treanda is indicated in patients whose disease has progressed during or within six months of treatment with Rituxan (rituximab), a drug marketed jointly by Genentech Inc. and Biogen Idec, or a regimen containing that product.
The FDA approval is supported by a 100-patient pivotal trial that demonstrated an overall response rate of 74 percent in patients who received Treanda as a single agent. Treanda achieved a 9.2 month median duration of response and a 9.3 month median progression-free survival response rate, said Charles Morris, Cephalon's vice president of worldwide clinical research.
The most serious adverse events in study participants included myelosuppression, infections, infusion reactions and anaphylaxis, tumor lysis syndrome, skin reactions and other malignancies, Morris told BioWorld Today.
Those reactions, he insisted, are "things that are generally manageable, and nothing we wouldn't expect in a typical oncology setting."
Treanda is administered as an intravenous infusion over 60 minutes. The recommended dosage for indolent NHL is 120 mg/m2 administered on days one and two of a 21-day cycle, for up to eight cycles.
The drug is a synthesized agent that combines an alkylating group and a purine-line benzimidazole ring, Morris explained. The exact mechanism of action of Treanda is unknown, he said. However, Morris noted, preclinical studies suggested that the agent may lead to cell death by apoptosis or mitotic catastrophe, a nonapoptotic pathway.
Cephalon gained the rights to Treanda from its 2005 buyout of San Diego-based Salmedix Inc., which was granted a license from German firm Astellas Deutschland GmbH. Mundipharma International Corp. Ltd., of Cambridge, UK, markets bendamustine hydrochloride, the active ingredient in Treanda, in Germany as a single agent or in combination with other anticancer agents for indolent NHL, multiple myeloma and CLL under a license from Astellas.
Tokyo-based SymBio Pharmaceuticals Ltd. holds exclusive rights to develop and market bendamustine in Japan and certain Asia-Pacific Rim countries.
Apriso Gains Approval
Also Friday, Raleigh, N.C.-based Salix Pharmaceuticals Ltd. said the FDA granted marketing approval for Apriso (mesalamine) extended-release capsules, a locally acting 5-aminosalicylic acid, to maintain the remission of ulcerative colitis, a chronic inflammatory disease of the colon or large intestine, in adult patients. The drug is the first and only mesalamine product approved by the FDA for once-daily dosing for the maintenance of remission of ulcerative colitis.
Salix's Intellicor extended-release delivery technology is designed to distribute the active ingredient in Apriso beginning in the small bowel and continuing throughout the colon. The drug's gelatin outer capsule quickly dissolves in the stomach to disperse microgranules into the digestive tract.
Apriso's approval is based on results from two randomized, double-blind, placebo-controlled multicenter, multinational studies of 562 adults in remission from ulcerative colitis, which showed that Apriso was more effective than placebo in maintaining long-term remission for six months in seven out of 10 patients and sustained improvement in rectal bleeding and bowel movement frequency.
Vascana Gets Complete Response
While Cephalon and Salix had reason to celebrate last week, the news from the FDA was much less positive for MediQuest Therapeutics Inc.
Regulators issued a complete response letter for the firm's new drug application (NDA) for Vascana (MQX-503), a topical therapy proposed to treat Raynaud's disease, a condition that affects about 11 million people in the U.S. and causes severe pain associated with chronic vasospasm episodes in patients' hands, feet and other extremities.
The agency said the Bothell, Wash.-based company's NDA could not be approved in its current form. MediQuest did not disclose the reasons for the complete response, stating only that the agency had raised issues that must be addressed by the firm before final marketing approval could be granted for Vascana.
There currently are no drugs approved in the U.S. to treat Raynaud's disease. n
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