FDA Approves First Maintenance Therapy Drug for Lung Cancer


 Lung cancer treatment typically plays out in stages: Doctors administer a first-line treatment such as chemotherapy or Avastin, wait to see if the tumor progresses, and then administer a second-line treatment such as Alimta or Tarceva. Now, two pharmaceutical companies are eager to advance a different approach to treating lung cancer. The approach, called “maintenance therapy,” removes the wait in between treatments. Patients are treated right after first-line therapy in the hopes of delaying or stopping cancer progression.

In the past week, both Eli Lilly and Roche have made news with their maintenance therapy drugs. The U.S. Food and Drug Administration recently approved the first maintenance drug to treat advanced non-small cell lung cancer (NSCLC), the most common form of the disease. Eli Lilly’s Alimta was shown in clinical trials to be effective against nonsquamous NSCLC in patients who had previously undergone first-line chemotherapy.  Non-squamous NSCLC includes the subtypes adenocarcinoma and large cell carcinoma. The drug is not indicated for patients with squamous cell NCSLC.

Alimta works by inhibiting three enzymes that cause the cancer to grow. The drug has been approved since 2004 to treat mesothelioma, a form of cancer typically linked to asbestos exposure.

Alimta may face competition from Roche. The company announced that its EGFR inhibitor Tarceva had extended the lives of lung cancer patients in a Phase III clinical trial. Tarceva is already approved for second-line therapy to treat both squamous and nonsquamous cancer, and pancreatic cancer. The FDA is expected to rule on Tarceva next January. Tarceva works by targeting a protein that is instrumental in cell growth in NSCLC.

Both companies are optimistic about maintenance therapy, but as BNET reports, the approach has yet to gain acceptance among physicians. Doctors may prefer to give patients a “drug holiday” instead of continous therapy.

NSCLC accounts for an estimated 85 percent of cancers. A report published in April found that the market for NSCLC therapies will more than double to $684 million by 2017. Companies developing lung cancer treatments include Clarient,  Endocare, NeoPharm, Genta, AmpliMed, and GlobeImmune.

Related post: Clarient Launches New Gene Mutation Test for Lung Cancer

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