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 cancer.
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 news release.
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 approval.
"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 ACS statement.
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 lung cancer.
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 failure.
The most common aderse events in patients receiving Avastin included weakness, abdominal pain, headache, diarrhea, nausea, and vomiting, says the FDA.
SOURCES: News release, FDA. News release, Genentech. American Cancer Society statement attributed to Len Licthenfeld, MD, deputy chief medical officer, American Cancer Society. FDA: "Questions and Answers on Avastin." WebMD Medical Reference: "Avastin Questions and Answers."
By Miranda Hitti
Reviewed by Louise Chang