Oncology Xagena

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Lung cancer, Tarceva receives positive opinion from CHMP

Tarceva ( Erlotinib ) has received a positive recommendation from the European Committee for Medicinal Products for Human Use ( CHMP ) for the treatment of non-small cell lung cancer, the most common form of lung cancer.

Tarceva is the first and only EGFR-targeted treatment to have shown a significant survival benefit in patients with non-small cell lung cancer ( NSCLC ) and offers new hope to the 370, 000 people suffering with lung cancer each year in Europe.

EGFR is a key component of the human epidermal growth factor receptor pathway, which plays a role in the formation and growth of numerous cancers.

The CHMP has recommended that Tarceva be indicated for the treatment of patients with locally advanced or metastatic non-small cell lung cancer after failure of at least one prior chemotherapy regimen.

No survival benefit or other clinically relevant effects of the treatment with Tarceva have been demonstrated in patients with EGFR-negative tumours.

The CHMP recommendation is based on data from a pivotal phase III study that compared Tarceva to placebo for the treatment of patients with advanced NSCLC, following failure of first or second-line chemotherapy.

Patients receiving Tarceva lived significantly longer than those in the placebo arm. There was also a significant increase in both the length of time before patients' disease symptoms deteriorated and the time when patients were stable and there was no progression of their cancer.
It was also observed that one out of three patients on Tarceva was alive at one year as opposed to only one of five in the placebo group.

There is no specific recommendation for EGFR IHC ( immunohistochemistry ) testing.

Lung cancer is the most common cancer worldwide with 1.2 million new cases annually with someone, somewhere dying of the disease every 30 seconds.
NSCLC accounts for almost 80 percent of all lung cancer cases and there are few treatment options available.

Tarceva is an investigational small molecule that targets the human epidermal growth factor receptor ( HER1 ) pathway.
HER1, also known as EGFR, is a key component of this signaling pathway, which plays a role in the formation and growth of numerous cancers.
Tarceva blocks tumour cell growth by inhibiting the tyrosine kinase activity of the HER1 signaling pathway inside the cell.

Similarly to the significant survival benefit in NSCLC, Tarceva has also shown survival benefit in a phase III study in locally advanced or metastatic pancreatic cancer patients.
The study met its primary endpoint of improving overall survival.

Source: Roche, 2005