Roche receives EU Approval of Avastin in Combination with Ta
· This marks the first approval for Avastin in combination with another targeted therapy
Basel, 8 June 2016 Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the European Commission has approved the use of Avastin ® (bevacizumab ) in combination with Tarceva ® (erlotinib ) for the first-line treatment of adult patients with unresectable advanced, metastatic or recurrent non-squamous non-small cell lung cancer (NSCLC) with Epidermal Growth Factor Receptor (EGFR)-activating mutations.
The pivotal phase II JO25567 study showed a statistically significant 46 percent relative reduction in the risk of disease progression or death (median PFS: 16.0 months versus 9.7 months; [HR]=0.54, p=0.0015) for people treated with the combination of Avastin plus Tarceva compared to Tarceva alone.1 Avastin and Tarceva each target pathways which are known to be key drivers in the development and growth of tumours. The beneficial effect of Avastin plus Tarceva is supported by results of other clinical studies which showed the combination was effective and tolerable.2,3
“The combination of Avastin and Tarceva represents a new standard of care for patients with this type of lung cancer,” said Sandra Horning, M.D., Chief Medical Officer and Global Head of Product Development. “This approval provides physicians in Europe with a powerful combination therapy that can significantly extend progression-free survival beyond one year, representing important progress for a group of patients who typically face a poor prognosis.”
Each year, an estimated 23,000 Europeans are diagnosed with non-squamous NSCLC with EGFR-activating mutations, the equivalent of more than 60 diagnoses every day.4-8 NSCLC is the most common type of lung cancer, the leading cause of cancer-related death in Europe and across the world.4,7-9 Of all cancers, lung cancer has the greatest global economic and societal impact, making improvements in outcomes for patients with lung cancer a key global healthcare challenge.10