The FDA approved Orca-T, issued a CRL to a NET imaging agent, and more.
|Articles|March 9, 2011
- December 2010
- Volume 4
- Issue 12
FDA Considers Approval of Fusilev for Colorectal Cancer
Author(s)OBTN
The FDA has notified Spectrum Pharmaceuticals that it will decide whether to approve Fusilev (levoleucovorin) for colorectal cancer within 6 months.
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The FDA has notified Spectrum Pharmaceuticals that it will decide whether to approve Fusilev (levoleucovorin) for colorectal cancer within 6 months. The current indications for Fusilev include osteosarcoma and methotrexate-related toxicity. In October 2009, the FDA rejected a request to approve Fusilev for colorectal cancer based on lack of efficacy. The manufacturer submitted additional data in support of its application to the FDA on October 29, 2010.
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The FDA has issued a CRL to LNTH-2501 for the localization of SSTR-positive NETs.
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