Roche lung cancer treatment gets marketing nod in China

The Swiss drugmaker said the approval followed priority review of Alecensa in China, and was granted eight and nine months after European Medicines Agency and US Food and Drug Administration approvals, respectively.

“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 Roche chief medical officer and head of global product development Sandra Horning.

“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.”

The company said the approval was based on primary analyses from the pivotal global phase III ALEX study, assessing Alecensa versus crizotinib in the first-line treatment of people with ALK-positive metastatic (advanced) NSCLC, the pharmacokinetics results in Asian patients from the phase III ALESIA study, also investigating Alecensa compared to crizotinib in the first-line setting, and two phase II studies assessing Alecensa in patients who had progressed on or were intolerant to crizotinib.

It said that in updated analyses of the phase III ALEX study presented at the 2018 American Society of Clinical Oncology annual meeting, the primary endpoint of investigator assessed progression-free survival was more than tripled in people who received Alecensa compared to those who received crizotinib.

Further supporting the use of Alecensa in that setting, the phase III ALESIA study - which met its primary endpoint and showed that Alecensa as an initial treatment “significantly reduced” the risk of disease worsening or death compared to crizotinib in Asian patients with ALK-positive NSCLC - would be submitted to the CNDA to complete a post-approval agreement.

Roche said that was the third phase III study to show that Alecensa was superior as an initial treatment compared to crizotinib in the type of lung cancer.

Unlike in western countries, lung cancer incidence rates had continued to rise in China, and the disease was said to be the most commonly diagnosed cancer type and the leading cause of cancer-related deaths.

NSCLC was the most common form of lung cancer, with ALK-positive NSCLC - a distinct form - commonly affecting younger people, and those with a light or non-smoking history.

Roche said around 5% of NSCLC cancer cases were ALK-positive, with approximately 75,000 people diagnosed with ALK-positive NSCLC every year.

Alecensa was now approved in more than 57 countries globally as an initial treatment for ALK-positive advanced NSCLC, including the US, Europe and Japan.

It was approved by the FDA and the EMA in November and December 2017, respectively.