FDA OKs Drug for Advanced Lung Cancer
Avastin Already Approved for Treating Colorectal Cancer
Oct. 12, 2006 -- The FDA has approved the colon cancer drug Avastin for use
with chemotherapy in treating advanced lung cancer.
Avastin may now be used with the chemo drugs carboplatin and paclitaxel as
an initial treatment for advanced cases of non-squamous, non-small cell lung
Lung cancer is the leading cause of cancer death for U.S. men and women.
Non-small cell lung cancer is the most common type of lung cancer. It
accounts for three out of four of the 174,400 new cases of lung cancer that are
expected to be diagnosed this year, according to the FDA.
"[The] FDA believes it is crucial for cancer patients to have many
treatment options available to them in their battle against this disease,"
says the FDA's Richard Pazdur, MD, in the FDA news release.
"With the approval of Avastin, patients with this type of lung cancer
will not only have access to another treatment option, but one that has been
shown in clinical trials to increase survival time," Pazdur says.
Avastin Starves Tumors
Avastin, which is given intravenously, is not a new drug.
The FDA first approved it in February 2004 for use in combination with
chemotherapy to treat metastatic colorectal cancer (cancer that has spread beyond
the colon or rectum).
Avastin is believed to target a growth factor called VEGF (vascular
endothelial growth factor). By blocking the action of VEGF, Avastin hampers the
growth of new blood vessels that bring blood to tumors.
Basically, the strategy is to deprive tumors of their blood supply, thereby
starving them. Such drugs are called angiogenesis inhibitors.
Avastin is made by Genentech.
Avastin plus chemotherapy "is the first therapy in 10 years to improve
on standard first-line treatment for advanced lung cancer and the first FDA
approved therapy ever to extend survival for these patients beyond one year in
a large, randomized clinical study," Alan Sandler, MD, says in Genentech's
Sandler headed the study upon which the FDA based Avastin's new approval. He
is the director of medical thoracic oncology at Vanderbilt-Ingram Cancer Center
in Nashville, Tenn.
The American Cancer Society (ACS) also weighed in on Avastin's new
"The approval of Avastin represents an important new option for patients
with the most common type of lung cancer," says Len Licthenfeld, MD, in an
Licthenfeld is the ACS' deputy chief medical officer.
"For decades, we've known that standard chemotherapy can improve
survival for lung cancer patients, but we have not made improvements in
survival beyond the gains made using that approach," Licthenfeld notes.
"That makes even the modest improvement in survival provided by Avastin
important," he says.
Avastin's new approval is based on a study that showed a 25% improvement in
overall survival in patients taking Avastin with chemotherapy, compared with
chemotherapy alone, says Genentech.
That study included 878 patients with advanced non-squamous, non-small cell
The patients had not received chemotherapy before the study. They were
randomly assigned to get chemotherapy or chemotherapy plus Avastin.
Fifty-one percent of those receiving Avastin plus chemotherapy survived for
at least one year, compared with 44% of those who got chemotherapy without
Avastin, according to Genentech.
On average, patients who received Avastin plus chemotherapy lived one year,
compared with 10 months for patients treated with chemotherapy alone.
The FDA says the most serious adverse events associated with Avastin,
including some deaths, were gastrointestinal perforations (holes in the stomach
or intestines), wound healing complications, bleeding (hemorrhage), blockage of
the arteries, abnormally high
blood pressure, low blood levels of a protein called albumin, and congestive heart
The most common adverse events in patients receiving Avastin included
weakness, abdominal pain, headache, diarrhea, nausea, and vomiting, says the FDA.