China National Drug Administration grants rapid approval of Roche's Alecensa (alectinib) as a treatment for ALK-positive lung cancer

F. Hoffmann-La Roche Ltd / China National Drug Administration grants rapid approval of Roche's Alecensa (alectinib) as a treatment for ALK-positive lung cancer . Processed and transmitted by Nasdaq Corporate Solutions. The issuer is solely responsible for the content of this announcement.

• Approval follows priority review of Alecensa in China, just eight and nine months after EMA and FDA approvals, respectively

Supporting data showed Alecensa significantly reduced the risk of disease progression or death by more than half compared to crizotinib

Lung cancer incidence rates in China have continued to rise, with NSCLC the most common form of the disease

Basel, 20 August 2018 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the China National Drug Administration (CNDA) has granted marketing authorisation for Alecensa® (alectinib) as a monotherapy treatment for patients with anaplastic lymphoma kinase (ALK)-positive, advanced non-small cell lung cancer (NSCLC). The approval follows priority review of Alecensa in China and has been granted just eight and nine months after European Medicines Agency (EMA) and US Food and Drug Administration (FDA) 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 Sandra Horning, MD, 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."

The approval is 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 have progressed on or are intolerant to crizotinib.