The positive opinion will now be submitted to the European Commission (EC) by a decision on marketing authorisation (MA) scheduled for the end of the year.
Eric Ducournau, Chief Executive Officer of Pierre Fabre Laboratories, said: “The CHMP’s positive opinion marks a critical step in our commitment to providing an additional effective therapeutic option for patients with advanced NSCLC with BRAF V600E mutation who currently have limited treatment options. We look forward to the European Commission’s decision to make BRAFTOVI + MEKTOVI available for patients with non-small cell lung cancer in Europe.”
The CHMP’s positive opinion is supported by data from the global, open-label, multicenter, and non-randomized Phase II PHAROS study study, which included 98 patients from 56 study centers in 5 countries[.[1]
At the primary analysis (cut-off date: 22 September 2022), the primary endpoint of the study (objective response rate [ORR] determined by independent radiological review [IRR]) was reached.
The PHAROS study showed that in patients with advanced NSCLC with a BRAF V600E, BRAFTOVI ®and MEKTOVI ®mutation, they provided significant clinical benefit with an ORR of 75% (95% CI: 62, 85) in treatment-naive NSCLC patients (n?59), with 59% of them maintaining a response for at least 12 months. For patients who had received prior therapy (n.39), the ORR was 46% (95% CI: 30, 63), with 33% maintaining a response for at least 12 months.