Anemia reported with unapproved Avastin combination

Genentech has received reports of several cases of microangiopathic hemolytic anemia (MAHA) in patients with solid tumors receiving Avastin (bevacizumab) in combination with Sutent (sunitinib malate, from Pfizer). In a dose-escalation study combining Avastin and Sutent, 5 of 12 patients at the highest Sutent dose level were diagnosed with MAHA. Avastin and Sutent combination therapy is not recommended and is not FDA approved.

Avastin is indicated for metastatic colorectal carcinoma, in combination with 5-FU-based chemotherapy; first-line treatment of unresectable, locally advanced, recurrent or metastatic non-squamous, non-small cell lung cancer (NSCLC), in combination with carboplatin and paclitaxel; and metastatic HER2-negative breast cancer in chemotherapy-naïve patients, in combination with paclitaxel.

For more information call (888) 835-2555 or visit www.fda.gov/medwatch/safety/2008/safety08.htm#Avastin.