FDA advisory committee votes against approval of Tarceva for lung cancer treatment

Dec 18 2009

Panel Votes Against Approval of Tarceva(R) as Maintenance Drug

Yesterday, an advisory committee to the Food and Drug Administration voted against the approval of Tarceva(R) (erlotinib) as maintenance treatment for advanced lung cancer patients.

The Drug Evaluation and Research Oncologic Drugs Advisory Committee (ODAC), a panel of independent medical and scientific experts and patient representatives that reviews drug safety and efficacy data, voted 12-1 against the approval. The panel's vote is not binding on the FDA which must reach a final decision by January 18, 2010.

At issue is whether Tarceva should be approved for first line maintenance monotherapy treatment for patients with locally advanced or metastatic non-small cell lung cancer and for those patients who have not progressed on first line treatments with a platinum-based chemotherapy.

"We are very disappointed with this recommendation," said Laurie Fenton Ambrose, Lung Cancer Alliance (LCA) President & CEO. "While we understand the importance of statistical analysis when evaluating drug approval, the Committee's recommendation fails to appreciate the practical patient applications, especially with no safety concerns noted. The result is additional limitations on already limited options."

Lung cancer is the leading cause of cancer death in the United States. It takes more lives than breast, prostate and colon cancers -- combined. Over 70% of lung cancers are diagnosed at an advanced stage when curative surgery is not an option. Tarceva(R) is critically important to many lung cancer patients as it provides an option with limited side effects and portability.

"I was given two months to live when I was diagnosed almost five years ago. Tarceva(R) changed my life," said Mike Stevens, four and a half year late stage lung cancer survivor and LCA-California Chair, in a statement read at the meeting. "During the nearly four years I was on Tarceva, I was able to travel with my wife for our 25th wedding anniversary, watch my daughter start college and my son turn 16. I truly owe my life and the quality of my life to Tarceva(R)."

"We hope that FDA leadership will not follow the recommendations of ODAC and will approve Tarceva(R) in the maintenance setting so that lung cancer patients have another option that will help them live longer and enjoy a heightened quality of life," concluded Fenton Ambrose.