Taiho Oncology Europe GmbH and Taiho Pharmaceutical Receive EC’s Conditional Marketing Authorization for Lytgobi to Treat Cholangiocarcinoma
Shots:
- The EC has granted conditional marketing authorization for Lytgobi monotx. to treat adult patients with LA or metastatic CCA with an FGFR2 fusion or rearrangement that have progressed after one prior line of systemic therapy
- The conditional marketing authorization was based on the (FOENIX-CCA2) open-label trial evaluating Lytgobi (20mg, qd) in 103 patients with unresectable, LA or metastatic intrahepatic CCA harboring FGFR2 gene rearrangements, incl. fusions
- The results showed that patients treated with Lytgobi achieved an ORR of 42% as assessed by independent review and m-DoR (9.7mos.) while 72% of the responses lasted >6mos.
Ref: PRNewswire | Image: Taiho
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