Tagrisso’s growth trends
AstraZeneca’s (AZN) Tagrisso was approved by the FDA first for the treatment of EGFR (epidermal growth factor receptor) T790M mutation-positive metastatic NSCLC (non-small cell lung cancer) and then as a first-line therapy for EGFR-mutated NSCLC. The drug has become the highest-selling drug in AstraZeneca’s portfolio. According to a first-quarter earnings investor presentation, the drug is already approved in 67 countries in first-line indications and 83 countries in second-line indications. Tagrisso reported $630 million in revenue in the first quarter, a YoY (year-over-year) rise of 92%.
While Tagrisso has already established itself as the standard of care in first-line EGFR-mutated NSCLC indications in US and Japanese markets, the drug is being successfully launched in the European Union and other ROW (rest of world) markets in a first-line setting.
Performance by market
In the US, Tagrisso reported $259 million in revenue from the US market, a YoY rise of 76%, mainly driven by its more than 60% penetration in the first-line EGFR-mutated NSCLC segment and its more than 80% penetration in the EGFR T790M mutation-positive metastatic NSCLC segment. The drug, however, reported a sequential decline in revenue in the first quarter due to a decline in inventory and certain gross-to-net adjustments in its selling price.
According to AZN’s first-quarter earnings investor presentation, Tagrisso’s sales rose 55% YoY in Europe, 163% in established ROW markets, and 108% in emerging markets. Tagrisso’s ongoing commercial launch in Denmark, France, and Italy in first-line EGFR-mutated NSCLC indications, its penetration in the range of 35%–50% in the first-line target patient population, its rising testing rates and increasing demand in second-line EGFR T790M mutation-positive metastatic NSCLC indications, and its improving access are the key revenue drivers for it in Europe. The drug reported $100 million in sales in Europe in the first quarter.
According to AZN’s first-quarter earnings conference call, in Japan, Tagrisso reported revenue of $123 million in the first quarter, a YoY rise of 153%. With two-thirds of the eligible patient population on Tagrisso therapy, the drug has the highest penetration rate in Japan. Finally, Tagrisso reported revenue of $138 million in Emerging markets, a YoY rise of more than 108%. China accounted for almost half of Tagrisso’s emerging market revenue and reported solid uptake in second-line EGFR T790M mutation-positive metastatic NSCLC indications, especially after the drug was added to the country’s National Reimbursement Drug List. AstraZeneca expects a regulatory decision for Tagrisso in first-line EGFR-mutated NSCLC indications in China in the second quarter.