Tagrisso’s revenue trends
In 4Q17, AstraZeneca’s (AZN) Tagrisso reported revenues of $304.0 million compared to $147.0 million in 4Q16. In 4Q17, Tagrisso witnessed ~23.0% growth on a quarter-over-quarter basis.
In fiscal 2017, Tagrisso generated revenues of $955.0 million, which is ~126.0% growth on a year-over-year (or YoY) basis. In 2017, revenues from the sales of Tagrisso represented 5.0% of AstraZeneca’s net revenues from product sales.
Tagrisso is approved in more than 60 countries. In 2017, in the US market, Tagrisso generated revenues of $405.0 million, which reflected ~59.0% growth on a YoY basis. Gradual increase in EGFR (epidermal growth factor receptor) T790M-mutation testing rates primarily contributed to the increase in disease diagnosis and simultaneous sale of the drug.
In the European market, Tagrisso generated revenues of $187.0 million, which reflected ~146.0% YoY growth. Increasing uptake of Tagrisso in Europe, favorable reimbursement decisions, and growth in EGFR testing rates primarily contributed to the revenue growth of Tagrisso in Europe in 2017.
At the end of 2017, Tagrisso received reimbursement in 15 European countries while more positive reimbursement decisions are expected in 2018. This trend is expected to push the revenue growth of the drug.
In 2017, in the emerging markets and Japan, Tagrisso reported revenues of $135.0 million and $219.0 million, respectively.
In December 2017, the FDA accepted AstraZeneca’s supplemental New Drug Application (or sNDA) for the use of Tagrisso for the treatment in the first-line setting of individuals with metastatic NSCLC (non-small cell lung cancer) whose tumors showed EGFR mutations.
The FDA sNDA is supported by data from the Phase 3 FLAURA trial. In the Phase 3 FLAURA trial, Tagrisso demonstrated improvement in PFS (progression-free survival) in treatment-naïve individuals with metastatic NSCLC with EGFR mutation compared to erlotinib or gefitinib, which use tyrosine kinase inhibitors in the first-line setting.
In November 2017, AstraZeneca also submitted sNDA and MAAv (variation to the Marketing Authorization Application) for approval of Tagrissio for the same indication (metastatic NSCLC with EGFR mutation) to Japan’s Pharmaceuticals and Medical Devices Agency and European Medicines Agency, respectively.
The approval of label expansion of Tagrissio in major established markets is expected to push the sales growth of the drug in 2018.
In the NSCLC drugs market, Tagrisso’s peer drugs used for NSCLC with EGFR mutation include Boehringer Ingelheim’s Gilotrif (afatinib), Roche’s (RHHBY) Tarceva, and AstraZeneca’s Iressa.