13 April 2025
A targeted combination of dabrafenib (a BRAF inhibitor) and trametinib (a MEK inhibitor) has shown significantly improved response rates, progression-free survival, and safety compared to traditional chemotherapy. Both drugs are FDA-approved for use in children, with age-appropriate formulations available , and each may also be used as monotherapy for other MAPK pathway-driven tumours. However, the use of these medicines requires BRAF mutation testing, which may limit access in LMICs. Of notice, these agents have a broader indication, such as for melanoma, and have a large use in adult diseases. The primary patents on dabrafenib and trametinib (owned by Novartis) expire in 2025 and 2029 respectively. Secondary patents on the combination extend to 2030, and additional formulation patents may last until 2033–2038. The primary dabrafenib patent is present in over 30 LMICs, with secondary patents on the combination in 25 LMICs. As part of the PADO–cancer process, the MPP was asked to explore licensing options for this combination.