Tarceva impresses again as it seeks to extend its EU licence
pharmafile | June 3, 2011 | News story | | NSCLC, Roche, Tarceva
Roche and its partner OSI Pharmaceuticals have released another series of positive results for its lung cancer drug Tarceva as it looks to extend the drug’s licence.
In the second phase III study in a Western population, Roche’s non-small cell lung cancer drug Tarceva (erlotinib) nearly doubled progression free survival in patients over expressing the EGFR mutation when compared to chemotherapy alone.
Patients on Tarceva in the EURTAC study achieved median progression-free survival of 9.7 months compared to 5.2 months on standard chemotherapy, whilst significantly reducing the risk of the disease getting worse by 63 per cent.
Roche and partner OSI (now apart of Astellas) applied to the EMA to extend the current EU label for Tarceva in June last year to include first line use for the drug.
Discussions are also ongoing with the FDA regarding a submission that will include the use of a companion diagnostic test to help identify EGFR patients who can use Tarceva.
Hal Barron, head of global product development at Roche, said: “This is an important step forward in our goal of providing personalised options for people with advanced lung cancer.
“Two studies have now shown that Tarceva as a first-line therapy for EGFR mutation-positive advanced lung cancer increased the time people lived without cancer worsening compared with standard chemotherapy.”
It was licenced in the EU as a maintenance therapy regardless of genetic profile in 2005, but Roche is now seeking a new licence as a first line treatment for EGFR patients, which should help boost sales of the drug.
It is also licenced in the EU for the treatment of patients with locally advanced or metastatic non-small cell lung cancer after failure of at least one prior chemotherapy regimen.
As a maintenance therapy, Tarceva has shown it can extend progression free survival by an average of 3.3 months, and made Roche CHF 1.33 million in sales last year.
Tarceva is a once-daily, oral, non-chemotherapy treatment for the treatment of advanced or metastatic NSCLC.
Further data on the drug will be shown at the upcoming ASCO cancer conference in Chicago starting today.
AstraZeneca’s rival product Iressa (gefitinib) is currently the only approved oral first line treatment, in combination with a doublet chemotherapy regime, for EGFR patients.
A 2010 study of Iressa published in the New England Journal of Medicine showed that it achieved a median progression-free survival of 10.8 months compared with 5.4 months from standard chemotherapy regimens.
Ben Adams
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