Roche’s Alecensa fast-tracked in China

China’s national regulator has granted a rapid approval for Roche’s lung cancer treatment Alecensa just months after European and American approvals, following a revamp of the country’s notoriously slow review process.

Roche announced that the China’s National Drug Administration (CNDA) has granted a rapid approval for Alecensa (alectinib) as a monotherapy treatment for patients with anaplastic lymphoma kinase (ALK)-positive, advanced non-small cell lung cancer.

China rebranded and restructured its regulator in 2013 and since then has been working to make the approval process for new drugs faster and more efficient.

The announcement follows priority review of the treatment in China and has been granted just eight and nine months after EMA and FDA approvals, respectively.

The approval is based on a series of primary results from the pivotal global phase 3 ALEX and phase 3 ALESIA assessing Alecensa versus Pfizer’s Xalkori (crizotinib) in the first-line treatment of people with ALK-positive lung cancer.

Alecensa has also been tested against Xalkori in phase 2 studies in patients who have progressed on or are intolerant to standard regimen.

Supporting data from all three trials showed Alecensa significantly reduced the risk of disease progression or death by more than half compared to Xalkori.

Roche’s Sandra Horning

Sandra Horning, Roche’s chief medical officer and head of Global Product Development, commented: “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.”

Chinese regulators have a long history of delayed drug approvals with many cases of treatment green-lighted years after other regions such as Europe and the United States. Today’s rapid approval of Alecensa might be an indication of changes in the Chinese regulatory system.

“It 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,” added Horning.

Lung cancer incidence rates in China have continued to rise, with NSCLC being the most common form of the disease. Lengthy reviews and the associated lack of access to drugs has often turned Chinese lung cancer patients towards the grey market.

Alecensa is now approved in over 57 countries around the world as a first-line treatment for ALK-positive advanced lung cancer, including the US, Europe and Japan.

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