FDA Gives Avastin First-Line NSCLC Indication

ROCKVILLE, Md., Oct. 12 -- The FDA has approved Avastin (bevacizumab), in combination with Taxol (paclitaxel) and Paraplatin (carboplatin), as first-line therapy for non-small-cell lung cancer (NSCLC).

In a phase III study of patients with unresectable, locally advanced, recurrent or metastatic non-squamous NSCLC, adding Avastin to the standard chemotherapy regimen extended survival by an average of two months, from 10.3 months to 12.3 months, a 25% improvement, according to Genentech, the maker of Avastin.

In announcing the latest Avastin indication -- the anti-angiogenic drug was already marketed for first- or second-line treatment of metastatic colorectal cancer -- Genentech also said that in January it would cap the annual price. No eligible patient taking Avastin for an FDA-approved indication would pay more than ,000.

The company said that the monthly price of Avastin for treatment of colorectal cancer is ,400 a month or ,800 a year, but the phase III trial in NSCLC used a higher dose boosting the price for Avastin to ,800 a month, or ,600 a year.

Price was on the mind of Len Lichtenfeld, M.D., deputy chief medical officer at the American Cancer Society, who said that while the Avastin approval was an important new option for patients with the most common form of lung cancer, the high price of drugs like Avastin "can have an immediate and dramatic effect on cancer patients and their families."

Dr. Lichtenfeld said that the high price of drugs like Avastin has the potential to "reduce access to the best available treatment because families with limited incomes will be forced to make choices based on their finances." He did not, however, comment directly on the Avastin pricing program announced by Genentech.

The phase III trial enrolled 878 patients who were randomized to Avastin plus chemotherapy or chemotherapy alone. One year survival was 51% in the Avastin arm versus 44% in the control arm. The trial was sponsored by the National Cancer Institute and coordinated by the Eastern Cooperative Oncology Group.

The most common toxicities among patients treated with Avastin were neutropenia, fatigue, hypertension, infection, and hemorrhage.

The rate of pulmonary hemorrhage requiring medical attention was more than twice as high in the 427-patient Avastin arm (2.3%, 10 patients and seven deaths) than in the 441-patient control arm (0.5%, two patients, one death).