The U.S. FDA has approved a new lung cancer pill for British drugmaker AstraZeneca.
AZD9291 is a drug that targets advanced non-small cell lung cancer, which is the most common type of lung cancer. The drug will be sold as Tagrisso, an 80-milligram once-daily tablet.
Tagrisso aims at a genetic mutation called T790M, which is responsible for helping tumors evade current lung cancer pills. It is the only approved medicine indicated for patients with metastatic EGFR T790M mutation-positive non-small cell lung cancer.
The price of Tagrisso, according to a spokeswoman will be "comparable to other oral cancer therapies." AstraZeneca will disclose the price early next week.
Tagrisso, developed in Cheshire, England, is estimated to rack in sales of $3 billion a year. Analysts, however, have cautiously dropped the figure to $1.1 billion in 2020.
AstraZeneca has "deep-rooted heritage" in the therapeutic area of oncology. CEO Pascal Soriot is acting on clinical evidence to make sure that Tagrisso is accessible to patients in the near future.
"The FDA approval of TAGRISSO marks an important milestone for lung cancer patients who urgently need new treatment options," Soriot shared in a press release.
Through the advancement of its lung cancer portfolio, AstraZeneca seeks to treat bigger numbers of patients, spanning all stages of the disease.
Lung cancer is the leading cause of cancer death for both men and women. It accounts for more than a third of all cancer deaths, a higher statistic than colorectal, prostate and breast cancers combined. With a 5-year survival rate of less than 20 percent, 85 percent of all lung cancers in the U.S. are non-small cell lung cancer, while 10 to 15 percent of such cases are EGFR mutation-positive.
A resistance related to the T790M mutation will then be acquired by two-thirds of patients who are treated with EGFR TKI therapy.
The approval of Tagrisso came only two-and-a-half years since it was first tested on humans. It has received breakthrough status, accelerated assessment and priority review in the U.S., Europe and Japan.
