Roche’s cancer medicine Tarceva (erlotinib), has received a negative opinion from the European Committee for Medicinal Products for Human Use (CHMP) for use in combination with gemcitabine chemotherapy for the first line treatment of advanced pancreatic cancer.
In spite of Roche’s confidence that the Tarceva combination treatment significantly increases patient survival, the European CHMP thought otherwise. Following the decision, Roche (Public, OTC:RHHBY) is willing to consider all options including request for re-consideration.
Tarceva (erlotinib) has been USFDA approved in November 2005 for the first-line treatment of patients with locally advanced, unresectable or metastatic pancreatic cancer in combination with gemcitabine chemotherapy.
Both US and EU applications were based on the Phase III study (PA3)[2] data which showed that treatment with Tarceva plus gemcitabine results in significantly longer survival compared to gemcitabine alone (22%). Moreover, 24% of patients receiving Tarceva plus gemcitabine were alive after one year, compared to 19% on gemcitabine alone.
Pancreatic cancer is considered the most aggressive form of cancer, killing more people in the first year of diagnosis. Roche on the other hand will pursue more clinical trials on Tarceva in order to realize its potential in treating pancreatic cancer.
Read more at Roche.
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Hi, May I know where we can get discounted Tarceva in the Philippines and is there a clinical trial for pancreatic patients? Thank you.
Posted by: Anonymous | July 16, 2009 4:37 AM | Permalink to Comment