Friday, June 14, 2013

Tarceva receives approval in Japan for additional indication - First line therapy in NSCLC patients with EGFR mutations

Chugai Pharmaceutical Co., Ltd has obtained approval by the Japanese Ministry of Health, Labour and Welfare (MHLW) on June 14, 2013, for the additional indication of “chemotherapy-naïve, unresectable, recurrent/advanced non-small cell lung cancer (NSCLC) with EGFR mutations,” for the epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor, "Tarceva® Tablet 25mg, 100mg and 150mg" [generic name: erlotinib hydrochloride] 

Chugai filed an application for approval for “chemotherapy-naïve, unresectable, recurrent/advanced NSCLC with EGFR mutationswith the MHLW based on the results from a Japanese phase II clinical trial and an overseas phase III clinical trial (The EURTAC trial).

Results of Phase 2 trial conducted in Japan patients

In the phase II clinical trial conducted in Japan in 103 NSCLC patients with EGFR mutations, the median progression-free survival, the primary endpoint, was 11.8 months (95% CI: 9.7 months - 15.3 months)1). The EURTAC trial compared Tarceva® monotherapy to platinum-based standard chemotherapies in 174 NSCLC patients with EGFR mutations. The study met its primary endpoint by demonstrating statistically significant improvement in median progression-free survival in patients who received Tarceva® monotherapy (10.4 months vs. 5.1 months), significantly reducing the risk of the disease getting worse by 66 percent compared with standard chemotherapies 

Results of the Global Phase 3 trial - EURTAC

The EURTAC trial was stopped at a pre-planned interim analysis as the study met its primary endpoint. In both studies, the safety profile was consistent with the previous reports related to Tarceva®, and Tarceva® was well tolerated.
Similar results were reported in the OPTIMAL trial, which is a study conducted in China with the same design as the EURATAC tria.

Tarceva® was approved for EGFR mutation positive NSCLCs in Europe in August 2011 and in the US in May 2013.

The number of patients newly diagnosed as lung cancer in Japan is estimated to be approximately 115,000 in 2015. The occurrence of EGFR gene mutation in NSCLC patients observed in the EURTAC study was approximately ten percent in the European patients and approximately 30 percent in Asian patients.

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