EC grants conditional marketing authorization for Taiho's Lytgobi

The European Commission has granted conditional marketing authorization for Lytgobi (futibatinib) monotherapy for the treatment of adult patients with locally advanced or metastatic cholangiocarcinoma (CCA) with a fibroblast growth factor receptor (FGFR2) fusion or rearrangement that have progressed after at least one prior line of systemic therapy.

The treatment for this rare form of bile cancer was developed by Taiho Oncology and Taiho Pharmaceuticals, both subsidiaries of Japanese drugmaker Otsuka Holdings (TYO: 4578).

While rare – in Europe, approximately 6,000-8,000 people are diagnosed with CCA1– this disease is associated with poor outcomes and is growing in prevalence worldwide, underscoring the need for new treatment options.