AstraZeneca gets FDA accelerated approval for lung cancer drug Tagrisso

There was some good news of Anglo-Swedish pharma major AstraZeneca (LSE: AZN) on Friday, when, under the USA’s accelerated approval program, the Food and Drug Administration cleared for marketing its new cancer treatment Tagrisso (AZD9291). The firm’s shares edged up just 0.47% to £40.94 in London trading.

The approval is for 80mg once-daily tabletsfor the treatment of patients with metastatic epidermal growth factor receptor (EGFR) T790M mutation-positive non-small cell lung cancer (NSCLC), as detected by an FDA-approved test, who have progressed on or after EGFR tyrosine kinase inhibitor (TKI) therapy. AZD9291 is the only approved medicine indicated for patients with metastatic EGFR T790M mutation-positive non-small cell lung cancer.

Blockbuster sales forecast

Tagrisso is one of several cancer investigational drugs that AstraZeneca hopes will rebuild its sales following patent losses on older drugs. This approval follows AstraZeneca's recent launch of Lynparza (olaparib) for ovarian cancer, taking the company closer to its goal of bringing six new cancer treatments to market by 2020. The company has previously forecast the drug could eventually sell as much as $3 billion a year. However, industry analysts are more cautious about sales in the next few years, with consensus expectations pointing to revenue of $1.1 billion in 2020, according to Thomson Reuters Cortellis. Tagrisso's path to market has been unusually fast, taking just over two and a half years from the start of clinical trials to approval in the world's biggest drugs market, a Reuters report noted.