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- Shire's Vyvanse approved for maintenance treatment in adults with ADHD
- FDA accepts Ziopharm's IND application for oral formulation of Zymafos
- Private FFS MA plans may be linked with higher costs for beneficiaries, GAO report shows
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- In Brief: California Supreme Court
FDA grants ImmunoGen's investigational skin cancer compound orphan drug status
Friday, March 12 2010 | Comments
What's This?
The Food and Drug Administration designated ImmunoGen Inc.'s IMGN901 an orphan drug for the treatment of Merkel cell carcinoma, a rare but highly aggressive neuroendocrine cancer of the skin.The company said it is working toward initiating pivotal testing of IMGN901 for this indication next year, pending the evaluation of additional clinical data and regulatory input.
The compound also obtained concurrent orphan status by the European Medicines Agency.
IMGN901 targets cancer cells that express the protein CD56, and ImmunoGen said the agent is in early clinical testing for other cancers besides Merkel cell carcinoma that also express CD56, including small-cell lung cancer, ovarian cancer and multiple myeloma.
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