Mirdametinib 1 mg, 2mg Suppliers & Bulk Manufacturers

Available Forms: Capsules

Available Strengths: 1 mg, 2mg

Reference Brands: Gomekli (USA), Ezmekly (EU/UK)

Category: Oncology Cancer Care

Mirdametinib is an orally administered small-molecule inhibitor of MEK1 and MEK2 (part of the RAS/RAF/MEK/ERK signalling pathway). It is indicated for the treatment of patients (2 years and older) with neurofibromatosis type 1 who have symptomatic plexiform neurofibromas that cannot be completely removed by surgery.

Product Description:

Mirdametinib inhibits MEK1 and MEK2. In neurofibromatosis type 1 the NF1 gene, which normally restrains RAS, is defective, so RAS signalling runs unchecked through the MAPK pathway. The tumours that result are benign but can be disfiguring, painful and dangerous by position, and they are frequently impossible to remove surgically because they weave through nerves. Blocking the pathway downstream shrinks them without an operation.

It is indicated for patients aged two and over with neurofibromatosis type 1 who have symptomatic plexiform neurofibromas not amenable to complete resection, taken on an intermittent schedule of three weeks on and one week off. The measurable benefit is tumour volume reduction, but the point patients feel is reduced pain and improved function. Class-specific toxicities require active surveillance: serous retinopathy and other ocular changes, reduced cardiac ejection fraction, acneiform rash, diarrhoea and raised creatine kinase.

Sourcing notes. Originator product, on patent, recently approved and marketed under different brand names in the United States and Europe. Two capsule strengths and a dispersible presentation support weight-based paediatric dosing, so both strengths are needed. Long-duration treatment gives predictable repeat demand. Oral, room temperature.