FDA Approves New Colon Cancer Drug
Vectibix Follows Chemotherapy for Colorectal Cancer That Has Spread
WebMD News Archive
Drug's Trials continued...
Overall survival was similar for both groups during the 48-week study.
"Almost everyone had progressed by 48 weeks," J. Randolph Hecht, MD,
tells WebMD. By "progressed," he means their tumors had worsened.
"But at eight weeks, the first look, 70% of the people had progressed on
best supportive care, while only 51% had progressed [with] Vectibix," Hecht
says. "That 20% or so difference persisted for awhile. By the time you get
to 32 weeks it was not a big difference."
Hecht has conducted U.S. studies of Vectibix, but he wasn't involved in the
European trial. He directs the gastrointestinal oncology program at the
University of California, Los Angeles.
In addition, tumors shrank in 8% of the patients taking Vectibix. In some
cases, those tumors shrank to less than half of their pretreatment size.
"At every time point that you looked at, if you were in the Vectibix arm
you were much less likely to have your tumor progress than if you were on the
best supportive care arm," Hecht says.
"That's another way of looking at that," says Hecht.
The most serious adverse events in the Vectibix studies included pulmonary
fibrosis (the formation of fibrous tissue in the lungs), severe skin
rashcomplicated by infections,
infusion reactions, abdominal pain, nausea, vomiting, and constipation.
The most common adverse events associated with the drug included skin rash,
fatigue, abdominal pain, nausea, and diarrhea.
Vectibix is made by Amgen, Inc. The drug company has committed to conduct a
postmarketing trial to show whether Vectibix improves patients' survival in
patients with fewer prior chemotherapies.