AstraZeneca PLC (LSE:AZN) shares swung 4% higher on Monday after blockbuster drug Tagrisso (osimertinib), with the addition of chemotherapy, has been approved in the US for a specific type of lung cancer.
Adult patients with locally advanced or metastatic epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC) will now be able to receive the treatment.
The approval followed a priority review by the Food and Drug Administration (FDA) based on the results from the FLAURA2 Phase III trial published in The New England Journal of Medicine.
It showed Tagrisso slowed disease progression in patients with advanced lung cancer.
Dave Fredrickson, executive vice president of AstraZeneca’s Oncology Business Unit, said: "This important new treatment option can delay disease progression by nearly nine additional months, establishing a new benchmark with the longest reported progression-free survival benefit in the 1st-line advanced setting.
“This approval reinforces Tagrisso as the backbone of EGFR-mutated lung cancer treatment either as monotherapy or in combination with chemotherapy.
“This news is especially important for those with a poorer prognosis, including patients whose cancer has spread to the brain and those with L858R mutations."
Shares were swapping for 10,482p.