China, where drug approvals historically have come years after those elsewhere, has opted to accept overseas trial data to accelerate approvals after high costs and a lack of access to new treatments have forced desperate patients to turn to the gray market when they get sick.
Roche said China’s speedy approval shows officials responsible for vetting new drugs have changed their thinking.
“It... represents a significant regulatory shift, with the approval received under unprecedented timelines,” Sandra Horning, MD, Roche’s chief medical officer.
Alecensa is one of the Basel-based company’s newest medicines and targets a relatively rare kind of lung cancer, affecting about 5 percent of non-small-cell lung cancer sufferers.
The drug won Chinese approval based on a main trial, called Alex, conducted with 303 people in 31 countries, as well as early results from a separate study that focused on Asian patients that is due to be completed in 2019.
The China market for Roche is modest but increasing in importance.
In the first half of 2018, its pharmaceuticals revenue in the country grew 9 percent to more than 1 billion Swiss francs ($1 billion), or about 5 percent of its total drug sales.
The Swiss company has also been developing manufacturing facilities within the country.
($1 = 0.9957 Swiss francs)