Chinese regulators approve Roche’s Alecensa in regulatory shift

pharmafile | August 20, 2018 | News story | Sales and Marketing Cancer, China, Roche, approval, lung cancer 

China’s National Drug Administration has granted rapid approval for Roche’s lung cancer treatment Alecensa (alectinib).

Chinese regulators have in the past approved drugs years later than other regions such as Europe and the United States. However the lengthy regulatory process and the associated lack of access to drugs has turned patients towards the grey market.

Nevertheless the approval of Roche’s Alecensa has come less than after the treatment was granted approval in the United States and in Europe by the FDA and the EMA respectively. The rapid approval suggests that Chinese regulators may be taking a new approach towards a speedier regulatory process.

The drug was granted approval for anaplastic lymphoma kinase or ALK positive lung cancer, an aggressive form of lung cancer. The approval marks a shift as Chinese regulators accepted overseas clinical trial data in order to facilitate a speedier approval.

“Today’s approval marks a new era for ALK-positive lung cancer patients in China, who now have a treatment option that offers a meaningful, sustained benefit compared with the previous standard of care,” said Dr Sandra Horning, Roche’s Chief Medical Officer and Head of Global Product Development. “It also represents a significant regulatory shift, with the approval received under unprecedented timelines. We are proud to be at the forefront of healthcare innovation in China by helping to bring Alecensa to patients as quickly as possible.”

Alecensa is now approved in 57 different countries as an initial first line treatment for ALK-positive advanced NSCLC.

Louis Goss

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