Since Roche‘s Zelboraf gained (vemurafenib) FDA approval in 2011, significant strides have been made in BRAF-targeted cancer therapies, underscoring the significance of combating BRAF mutations in melanoma. Against this backdrop, Pfizer‘s Braftovi (encorafenib) is positioned to secure a dominant 42 per cent share of the BRAF inhibitors market for melanoma by 2028, underscoring its pivotal role in cancer therapy. Braftovi’s emergence underscores Pfizer’s commitment to advancing oncological treatments to address critical medical needs, according to GlobalData.
GlobalData’s patient-based forecast reveals that the BRAF inhibitor market for melanoma will reach a key milestone by 2028, with over $1 billion in sales in eight major markets (the US, Canada, France, Germany, Italy, Spain, the UK, and Australia). Pfizer’s Braftovi will take the lead, boasting $424 million in sales, with Novartis’ Tafinlar (dabrafenib) in second place with $364 million and 36 per cent of the overall BTK inhibitor therapy market by 2028.
Biswajit Podder, Oncology and Hematology Analyst at GlobalData, comments, “Braftovi, in combination with Eli Lilly’s Erbitux (cetuximab), is used for patients with metastatic colorectal cancer harboring the BRAF V600E mutation. Braftovi’s role is expected to grow in the future because of its October 2023 approval, together with Mektovi, for the treatment of metastatic BRAF-mutated non-small cell lung cancer (NSCLC) newly diagnosed patients or those who received prior therapy but not BRAF inhibitors.”
The approval is based on a Phase II clinical study (PHAROS; NCT03915951), which found a 75 per cent objective response rate in treatment-naïve individuals and 46 per cent in previously treated patients.
Braftovi, in combination with Pfizer’s Mektovi (binimetinib), outperforms its close competitor, Tafinlar, in combination with Novartis’s Mekinist (trametinib), in efficacy, tolerability, and side effects. This regimen is approved for melanoma that has spread or cannot be removed by surgery. Combining MEK inhibitors with BRAF kinase inhibitors would delay mitogen-activated protein kinase (MAPK)-driven acquired resistance and increase response rate and duration.
Podder concludes, “After FDA approval of Braftovi, the European Medicines Agency received an MAA for the combination of Braftovi and Mektovi to treat treatment-naïve NSCLC harboring BRAF V600E mutation. GlobalData reports 27 Phase I-III ongoing clinical trials investigating its effectiveness in solid and hematological cancers. If Braftovi gets approval for other indications, like relapsed multiple myeloma or metastatic brain tumor, or in combination with immunotherapy for melanoma, it will strengthen its market position.”