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U.S. BIOSCIENCE's HEXALEN APPROVED FOR PERSISTENT/RECURRENT OVARIAN CANCER; LAUNCH OF FIRST U.S. BIOSCIENCE PRODUCT SCHEDULED FOR LATE JANUARY

Executive Summary

U.S. Bioscience will launch its first product, the anticancer drug Hexalen, later in January following FDA approval on Dec. 26. Hexalen (altretamine) received a 1-A rating (new molecular entity representing a significant therapeutic advance) from FDA. The drug is indicated for "use as a single agent in the palliative treatment of patients with persistent or recurrent ovarian cancer following first-line therapy with a cisplatin and/or alkylating agent based combination," according to the approved labeling. The company estimated that there are 20,000 new cases of ovarian cancer in the U.S. each year, resulting in approximately 12,000 deaths. Hexalen, also known as hexamethylmelamine, was originally developed by NCI. It has been used clinically for almost two decades as a Group C drug. The company said that it expects the transition from Group C to commercial access of the drug to go smoothly. Due to the relatively small size of the prescribing group of doctors (roughly 1,000), U.S. Bioscience plans to detail the product through its own six-person sales force. Launch activities will include direct mailings to gynecologic oncologists, medical oncologists, pharmacists, and pharmaceutical wholesalers. The sales force is tentatively scheduled to begin detailing on Jan. 28. The product will be distributed through wholesalers at a price not yet disclosed. U.S. Bioscience plans to scale-up the size of its sales force to about 30 reps in time for its next product launch, which will likely be for its radio-protective agent Ethyol (ethiofos). The company anticipates filing an NDA for that product in early 1991. U.S. Bioscience licensed Hexalen from Wyeth-Ayerst three years ago, and filed an NDA in December 1988. Hexalen was recommended for approval by FDA's Oncologic Drugs Advisory Committee in June 1989. U.S. Bioscience President and CEO Philip Schein predicted later in 1989 that he hoped for an approval in the first quarter of 1990 ("The Pink Sheet" Dec. 4, 1989, T&G-11). This November, Schein said that the agency's final sign-off on the NDA had been delayed in part by the budget crisis in the fall ("The Pink Sheet" Dec. 3, 1990, T&G-9). Hexalen is delivered orally in 50 mg capsules. In studies supporting approval, the drug was administered as a single-agent for either 14 or 21 days in a 28-day cycle. Labeling notes that in 51 patients with measurable or evaluable disease, "there were six clinical complete responses, one pathologic complete response, and two partial responses for an overall response rate of 18%." The duration of responses ranged from two months to 36 months. "In some patients," the labeling adds, "tumor regression was associated with improvement in symptoms and performance status." The drug is contraindicated in patients with severe bone marrow depression or neurological toxicity. Adverse reactions reported in the approved label include nausea and vomiting, peripheral sensory neuropathy (dizziness, mood disorders, etc.), leukopenia and thrombocytopenia. The labeling for Hexalen includes three boxed warnings: (1) the drug "should only be given under the supervision of a physician experienced in the use of antineoplastic agents"; (2) "Peripheral blood counts should be monitored at least monthly, prior to the initiation of each course of Hexalen, and as clinically indicated"; and (3) "Because of the possibility of Hexalen-related neurotoxicity, neurologic examinations should be performed regularly during Hexalen administration." Hexalen has been studied at NCI in breast cancer, small cell lung cancer, lymphomas, and cervical cancer, and "has been shown to be active" in treating those diseases, the company said. U.S. Bioscience will begin its own trials "in the early part of 1991" using Hexalen in combination with carboplatin and cisplatin in the treatment of small cell, breast and ovarian cancers, the company said.
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