Shares of ImmunoGen, Inc. (NASDAQ: IMGN) shot up as much as 3% in midday Wednesday after it announced that the US Food and Drug Administration (FDA) has granted orphan drug designation to its lorvotuzumab mertansine (formerly IMGN901) product candidate when used for the treatment of small-cell lung cancer (SCLC). Through a separate process, ImmunoGen has received a positive opinion for lorvotuzumab mertansine as an orphan medicinal product for the treatment of SCLC from the European Medicines Agency (EMA) Committee for Orphan Medicinal Products (COMP) and is awaiting final designation from the European Commission. The compound previously was granted orphan drug designation for the treatment of Merkel cell carcinoma in both the US and European Union.
In the US, the Orphan Drug Act is intended to encourage companies to develop therapies for the treatment of diseases that affect fewer than 200,000 people in this country. Orphan drug designation provides ImmunoGen with seven years of market exclusivity that begins once lorvotuzumab mertansine receives FDA marketing approval for the treatment of SCLC. It also provides certain financial incentives that can help support the development of the compound for this indication.
In the US, the Orphan Drug Act is intended to encourage companies to develop therapies for the treatment of diseases that affect fewer than 200,000 people in this country. Orphan drug designation provides ImmunoGen with seven years of market exclusivity that begins once lorvotuzumab mertansine receives FDA marketing approval for the treatment of SCLC. It also provides certain financial incentives that can help support the development of the compound for this indication.
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