Ojemda(tovorafenib)

Ojemda (tovorafenib) is a drug for which an Orphan designation was granted on 20 May 2021. The application for marketing authorisation was submitted on 26 February 2025, with a procedure start date of 27 March 2025. A CHMP positive opinion for Conditional Marketing Authorisation is anticipated on 26 February 2026, and the CHMP opinion date for New Active Substance (NAS) status is also 26 February 2026. An accelerated assessment request was not granted on 30 January 2025. The approval date for Ojemda was 23 April 2024.

In the FIREFLY-1 study, which included 137 patients across 32 study sites in 11 countries, the best response to prior MEK and/or BRAF inhibitors included Partial response in 19, 8, and 27 patients, and Stable disease in 20, 19, and 39 patients. For patients with prior MEK and BRAF inhibitors, Partial response was observed in 2 and 4 patients, and Stable disease in 3, 1, and 4 patients. For those with prior MEK inhibitors, Partial response was observed in 16 patients. The safety analysis set included 77 patients, with 54 patients ongoing primary study treatment. Notable safety findings (Any Grade) included Vomiting (56.2%) and Headache (52.6%). Oedema was reported as very common (33.6%).