A new lung cancer treatment from the British company AstraZeneca PLC (LON: AZN) received the early approval of the U.S. Food and Drug Administration (FDA).
The pill, named Tagrisso and also known as AZD9291, is designed for those patients whose conditions have got worse after being treated by other means. The company expects to rebuild its sales after losing the patents of their older drugs.
The federal entity approved the once-daily tablet for treating a group of patients suffering from an advanced type of lung cancer earlier than it was expected, as the FDA announced the decision was set to be made by February 2016.
A complete or partial reduction on the tumor size was showed by patients in two clinical trials of the company. According to the information, 57 and 61 percent of the subjects showed improvements on fighting the disease, although the more common side effects were diarrhea, and skin and fingernail problems.
Paul Hudson, head of AstraZeneca, said that the drug will be launched next week, and it will be available for the price of $25 per month. “We’ve worked very hard at early conversations with payers and plans, and we’ve had very positive conversations to date. We’re expecting to be able to get the right level of access to patients,” he said to the Wall Street Journal.
According to Thomson Reuters Cortellis, analysts predict that the sales of the drugs will provide the company with a revenue of $1.1 billion in 2020, although the company believes that they could sell it for an amount of $3 billion a year.
What about Tagrisso?
Tagrisso works by targeting a genetic mutation, known as T790M, that makes the disease resistant to the regular cancer treatments. A rival company, named Clovis Oncology, is also developing a similar product. In order to detect this mutation on lung cancer patients, the FDA also approved a new diagnostic test, developed by Roche, to determine the use of Tagrisso.
Tagrisso has made its way to the market pretty fast, as its early clinical trials took place only 2 years ago when AstraZeneca started pushing hard to develop the drug so the FDA accelerated the approval process.
The analyst Eric Cruscuolo said that “the speedy FDA decision suggested a similarly early approval of Clovis’ rival drug rociletinib, whose official FDA decision date is at the end of March. “Rociletinib could be right behind,” according to Reuters.
AstraZeneca continues to follow their goal of bringing six new cancer treatments to the market by 2020, as they recently launched Lynparza, a drug for ovarian cancer. Nevertheless, the launch of Tagrisso could be huge news given that lung cancer is the leading cause of cancer death in the U.S., according to the Centers for Disease Control and Prevention.