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Small cell lung cancer treatment receives orphan drug designation

FDA also approved new drug application for drug used in chemotherapy-induced nausea and vomiting.

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Last week, the FDA assigned orphan drug designation to amrubicin, a third-generation anthracycline analogue, for treating small cell lung cancer, according to a press release.

The FDA’s orphan drug designation provides products with seven years of market exclusivity, regulatory fee reduction and additional regulatory support for research and development, according to the March 25th announcement.

Researchers are currently studying amrubicin (Celgene Corporation), a potent topoisomerase II inhibitor, as a single agent and in combination with anticancer therapies for various solid tumors, including breast and lung cancer. The drug is currently approved and marketed in Japan for the treatment of small cell lung cancer.

Also last week, the FDA granted approval of the abbreviated new drug application for ondansetron hydrochloride injection USP, 2 mg/mL (Taro Pharmaceuticals Industries Ltd.), which is used in the prevention of chemotherapy-induced nausea and vomiting. This new sterile injectable prescription product is bioequivalent to the ondansetron hydrochloride (Zofran) injection, 2 mg/mL, manufactured by GlaxoSmithKline.