FDA Approves Alimta As Lung-Cancer Maintenance Therapy

The U.S. Food and Drug Administration has approved Alimta, an Eli Lilly & Co. (LLY) drug, as the first maintenance treatment for advanced lung cancer.

Traditionally patients with advanced, or metastatic, lung cancer that has spread to other parts of the body, are treated with four to six rounds of chemotherapy, and then treatment is stopped in patients whose tumors either stop growing or shrink.

Now, the FDA has given doctors the official go-ahead to continue treatment with Alimta in patients with certain types of non-small cell lung cancer. Alimta, considered a less-toxic chemotherapy drug, is initially given with cisplatin to treat lung cancer.

Until recent studies were released earlier this year showing that drugs like Alimta can prolong lives without the side-effects of initial treatment with chemotherapy, doctors typically waited until tumors started growing again before starting more treatment.

"This drug represents a new approach in the treatment of advanced non-small cell lung cancer," said Richard Pazdur, FDA's Office of Oncology Drug Products director.

Many doctors also give drugs such as Avastin or Tarceva in addition to chemotherapy. Avastin, marketed in the U.S. by Roche Holding AG's (RHHBY) Genentech unit, blocks blood vessels that feed cancerous tumors while Tarceva, also marketed by Genentech along with OSI Pharmaceuticals Inc. (OSIP), blocks an enzyme involved in cancer growth. The companies are waiting for FDA approval of Tarceva as a maintenance therapy for certain advanced-lung-cancer patients.

Alimta, first approved in 2004, is now approved specifically for patients who have nonsquamous non-small cell lung cancer whose disease hasn't progressed after four cycles of platinum-based chemotherapy.

The FDA said a clinical trial that involved more than 600 patients, people with predominantly squamous cell cancer, didn't benefit from Alimta. But those with other subtypes of non-small lung cancer survived an average 15.5 months following treatment compared with 10.3 months for patients who received a placebo treatment. All patients were initially treated with standard chemotherapy. Side-effects seen in the study included fatigue, nausea, loss of appetite, tingling or numbness in the hands and feet, and skin rash.

Most people with lung cancer are diagnosed with advanced-stage disease that cannot be surgically removed or has spread to other parts of the body. The majority of people with advanced lung cancer survive less than one year.

-By Jennifer Corbett Dooren, Dow Jones Newswires; 202-862-9294; [e-mail]