FDA Approves Alimta As Lung-Cancer Maintenance Therapy
07 July 2009 - 2:05AM
Dow Jones News
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;
jennifer.corbett@dowjones.com