Pierre Fabre Laboratories has received the European Commission (EC) approval for Braftovi (encorafenib) plus Mektovi (binimetinib) to treat adult patients with advanced non-small cell lung cancer (NSCLC) with a BRAFV600E mutation.
Braftovi is a highly selective BRAF inhibitor with a distinct pharmacological profile compared with other BRAF inhibitors, and Mektovi inhibits kinases in the MAPK pathway.
In October last year, Pierre Fabre’s partner Pfizer announced the US Food and Drug Administration (FDA) approval for Braftovi plus Mektovi for the same indication.
The combination is also approved in other countries for the treatment of adult patients with metastatic colorectal cancer (mCRC) with a BRAFV600E mutation, who received prior therapy.
Pierre Fabre Laboratories CEO Eric Ducournau said: “We are pleased to be able to extend the treatment of Braftovi (encorafenib) in combination with Mektovi (binimetinib) to adult patients with advanced NSCLC with a BRAFV600E mutation in Europe.
“There are currently limited targeted treatment options for BRAFV600E mutant NSCLC patients, so this approval is a significant milestone as Braftovi plus Mektovi will give patients the option of an additional effective targeted therapy.”
The approval follows a positive opinion by the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP), issued on 25 July.
The EC approval is based on positive results from the PHAROS, an open-label, multicentre, non-randomised, Phase 2 clinical trial.
The Phase 2 study evaluated the efficacy and safety of Braftovi plus Mektovi in treatment-naïve and previously treated patients with BRAFV600E mutant metastatic NSCLC.
In the primary analysis, the study met the primary endpoint of objective response rate (ORR), as determined by independent radiology review (IRR).
The drug regimen resulted in a 75% ORR in the treatment-naïve population, including 15% complete responses (CRs) and 59% partial responses (PRs).
An additional 10-month follow-up showed that 64% of patients maintained a response for at least 12 months, with a median duration of response (mDOR) per IRR of 40 months.
The most common treatment-related adverse events, including nausea, diarrhoea, fatigue, and vomiting, occurred in 14% of patients, with the most common being colitis.
Pierre Fabre Laboratories medical, patient, and consumer affairs head Núria Perez-Cullell said: “The EC approval highlights our ongoing commitment to bring meaningful change to patients with diseases such as lung cancer where there is a high unmet need.
“Through our longstanding partnership with Pfizer, we have been able to utilize our capabilities and experience to deliver this innovative treatment combination for patients with BRAFV600E mutant advanced NSCLC.
“We remain committed to harnessing the full potential of our clinical development programme so that we can continue to bring promising targeted oncology compounds to patients in Europe.”
Pfizer holds exclusive rights to commercialise Braftovi and Mektovi in the US, Canada, and all countries in the Latin American, African, and Middle Eastern regions.
Ono Pharmaceutical holds exclusive rights to both products in Japan and South Korea, Medison in Israel and Pierre Fabre in all other countries, in Europe and Asia-Pacific.
