IND Safety Letters

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IND Safety Report Summary (updated 07/15/2010)**

BY DATE:

• 15JUL2010

• 15JUN2010

• 17MAY2010 Two changes have been made since original post:
  Page Correction - Zactima 2010SE14148(2)

  Page Correction - Avastin 300105(0)

• 15APR2010  

• 17MAR2010  Two changes have been made since original post:
  Name Correction - 2009SE10146 to 2009SE10143

  Page Corrections - Zactima 2009SE30784  (missing pg 2&3 in original doc) 

   

BY DRUG NAME:

• Alimata (pemetrexed) - No INDs*
  • LUN08-137 
• AMG479 - Amgen safety dept distributes INDs to sites directly.
  • LUN08-129  
• Amrubicin (Calsed) (updated 7/15/10)
  • LUN07-130 
• ASA404 (updated 5/17/10)
  • GU09-144
• Aprepitant - No INDs*
  • QL05-37
• Avastin (bevacizumab)  (updated 07/15/10)
  • BRE06-109, COE-02, GU04-75, LUN04-77, LUN05-99, LUN06-116
• BNC-105 - No INDs*
  • GU-145
• Erbitux (cetuximab) (updated 10/07/09)
  • GI05-92, GI05-102, LUN04-79
• Dasatinib (Sprycel) (updated 11/06/09 - IB only)
  • GU07-122, GU07-124
• Enzastaurin (updated 12/04/08)
  • BRE05-97, BRE06-117, LUN06-116
• Lonafarnib (updated 06/15/2010)
  • BRE07-126
• Procrit /Aranesp (epoetin alpha) (updated 09/17/08)
  • No open studies
• RAD001 (everlimus) (updated 07/15/10)
  • GI05-102, GU09-145, GU10-147
• Sutent (sunitinib malate) - No INDs*
  • GI06-112, GU07-123
• Tarceva_(erlotinib) (updated 10/09/08)
  • GI06-101
• Taxol (paclitaxel) - No INDs*
  • GI06-112
• Treanda (bendamustine) (updated 7/15/2010)
  • MM08-141
• Zactima (vandetanib) (updated 07/15/10)
  • LUN06-113
• Zometa (zoledronic acid)  (updated 04/14/08)
  • No open studies

* NO INDs: We are in the process of verifying with the drug companies that no INDs are currently available for the listed drug. If there are any necessary INDs for these drugs, we will include these in the monthly IND notification.

 ** PLEASE NOTE: The date indicated in the IND Safety Report Summary is the date on the letter received from the drug company. The file date on the individual IND Safety Reports is the date the report was uploaded to the website and may not correspond to the date in the IND Summary.