IND Safety Letters

Username: HOG_CRA

Password:  (contact Deb Cole if you need help)

BY DATE:

• 18JAN2012

• 15DEC2011

• 16NOV2011

   

BY DRUG NAME:

• Alimata (pemetrexed) - No INDs as is an SMO*
  • LUN08-137 
• AMG479 - Amgen safety dept distributes INDs to sites directly.
  • LUN08-129  
• Amrubicin (Calsed) (updated 3/17/11)
  • LUN07-130 
• ASA404 (updated 11/17/10)
  • GU09-144
• Avastin (bevacizumab)  (updated 6/15/2011)
  • BRE06-109, COE-02, GU04-75, LUN04-77, LUN05-99, LUN06-116
• BNC-105 - No INDs PM will distribute directly to sites*
  • GU-145
• Erbitux (cetuximab) (updated 01/18/2012)
  • GI05-92, GI05-102, LUN04-79
• Dasatinib (Sprycel) (updated 01/18/2012)
  • GU07-122, GU07-124
• Imetelstat - No INDs - sites receive directly from Geron since SMO
  • BRE10-150
• Irinotecan (updated 8/16/2011)
  • GI05-102
• Lonafarnib (updated 03/17/2011)
  • BRE07-126
• PF-01367338 (formerly known as AG-014699) (updated 9/15/2011)
  • BRE09-146   *Bi-Annual Line Items *
• RAD001 (everlimus) (updated 01/18/2012)
  • GI05-102, GU10-147
• Sutent (sunitinib malate) (updated 09/15/10)
  • GI06-112, GU07-123
• Treanda (bendamustine) (updated 01/18/2012)
  • MM08-141
• Velcade (bortezomib) (updated 11/16/2011)
  • LYM08-134
• Zactima (vandetanib) (updated 01/18/2012)
  • LUN06-113