Paul Hudson, head of AstraZeneca, USApast year, Chief Executive Pascal Soriot had warned that the new cancer pill's progress could be disrupted by the distraction of a mega-merger. AstraZeneca can be working a seamless section-three medical trials on Tagrisso to assemble extra information on the drug's security and effectiveness.
Tagrisso, developed in Cheshire, England, is estimated to rack in sales of $3 billion a year.
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. The drug targets at a genetic mutation, T790M, which let tumors to skip now available lung cancer drugs.
AstraZeneca has "deep-rooted heritage" in the therapeutic area of oncology. That pace reflects an accelerated approval process at the FDA and AstraZeneca's determination to push development as fast as possible.
Lung cancer is the leading cause of cancer death for both men and women. With a 5-year survival rate of less than 20 percent, 85 percent of all lung cancers in the US are non-small cell lung cancer, while 10 to 15 percent of such cases are EGFR mutation-positive. It approval comes for patients in two categories, those having tumors with specific epidermal growth factor receptor (EGFR) mutation (T790M), and those whose condition worsened following the use of other EGFR-blocking therapies.
Furthermore, Alberto Gutierrez, MD, is the director of the FDA Center for Devices and Radiological Health's Office of In Vitro Diagnostics and Radiological Health "The approval of safe and effective companion diagnostic tests and drugs continue to be important developments in oncology". It had received breakthrough status in the United States and has also received an accelerated assessment in the European Union following its filing in the summer, as well as priority review in Japan.