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Adalvo Advances Binimetinib Development Towards Day-1 Launch Readiness

Business
10 July 2025

Adalvo is progressing its Binimetinib program, targeting a Day-1 launch opportunity upon expiry of the IP Rights in major regulated markets through a clearly defined IP strategy. The program is also designed to support early entry within the oncology market in certain territories. 

Binimetinib, developed as a generic version of Mektovi®, is used in combination with another medicine*, and is indicated for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 mutation, a population where treatment options are limited and clinical urgency is high. 

The National Comprehensive Cancer Network® (NCCN) has given this combination a Category 1 recommendation as a first-line systemic therapy, based on evidence showing it more than doubles median progression-free survival (PFS) compared to control therapies. 

With lifecycle innovation in mind, Adalvo’s program includes both 15 mg and 45 mg tablet strengths, supporting improved dosing flexibility and streamlined administration. 

According to IQVIA, global sales of Binimetinib reached approximately $455 million in 2024, with a 3-year CAGR of 19%

Adalvo’s oncology portfolio is built around technical depth, regulatory clarity, and a focus on delivering partner-ready assets where global market access and medical value align. 

To explore licensing opportunities or access Adalvo’s oncology portfolio, contact the team today. 

*Encorafenib (Braftovi®)