Tarceva as an effective FIRST LINE STAND ALONE treatment!!!

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Tarceva Found to be Effective in Treating Lung Cancer

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Genetech Inc and OSI Pharmaceuticals have announced their drug Tarceva is effective in delaying the advance of lung cancer. Tarceva is a target agent that is currently used as a second line treatment for patients with Non-small cell lung cancer (NSCLC) after they have failed chemotherapy. OSI and Genentec said their drug met its main goal in a primary treatment clinical trial as it stopped the spread of advanced NSCLC significantly longer than placebo.

The clinical trial called SATURN (SequentiAl Tarceva in UnResectable NSCLC) involved 889 patients at 160 lung cancer treatment centers worldwide. The patients were given Tarceva, a once-per-day oral drug after receiving at least four cycles of standard chemotherapy. A control group was given placebo. The patients who received Tarceva significantly extended their life without advancing cancer.

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Lung Cancer Symptoms and Treatment

Tarceva had previously been used in patients whose treatment had failed. SATURN showed the drug is effective as a first-line treatment, without the side effects of chemotherapy.

Lung Cancer is the most common cancer in the world and NSCLC accounts for almost 80% of all lung cancers. There are 1.4 million new cases of lung cancer diagnosed annually. The majority of NSCLC cases are diagnosed at an advanced stage when the cancer is inoperable or has spread to another part of the body. Less than 5% of people with advanced Non-small cell lung cancer survive for 5 years after diagnosis.

Treatment of NSCLC has proven difficult and in October the results of a late-stage clinical trial to prove the benefits of combining Genetech’s cancer drug Avastin with the drug Tarceva did not show an improvement in the overall survival of patients with lung cancer.

Tarceva has been approved in the European Union since September 2005 and in the US since November 2004 for the treatment of patients with metastatic Non small cell lung cancer, after failure of at least one prior chemotherapy regimen. It is well tolerated without the side effects usually associated with chemotherapy, such as nausea and vomiting.

Doctor Hal Barron, Genetech’s chief medical officer, said the findings “represent another step forward in our hopes of providing more options to patients…” “Tarceva remains our core asset and principle source of revenue, and we were really pleased to see the study results,” said Colin Goddard, OSI’s chief executive officer.

The results of the trial will be submitted to the U.S. Food and Drug Administration where Genetech and OSI hope to gain approval to use Tarceva in earlier states of lung cancer treatment. The results of SATURN are a step forward in the treatment of lung cancer.

OSI Pharmaceuticals is based in Melville, N.Y. and Genetech is based in San Francisco. Roche Holding of Switzerland conducted the trial.

The complete results of the Tarceva trial in the treatment of lung cancer will be reported at a future medical conference.

By: Toni Brayer MD - Sat, 11/08/2008 - 16:51