FDA Approval Insights: Futibatinib in FGFR2-Positive Cholangiocarcinoma

Dr Goyal discusses the FDA approval of futibatinib in FGFR2-positive cholangiocarcinoma, key safety data from the FOENIX*-CCA2 trial, and the importance of biomarker testing in the cholangiocarcinoma population.

Welcome to OncLive On Air®! I’m your host today, Ashling Wahner.

OncLive On Air® is a podcast from OncLive®, which provides oncology professionals with the resources and information they need to provide the best patient care. In both digital and print formats, OncLive® covers every angle of oncology practice, from new technology to treatment advances to important regulatory decisions.

In today’s episode, we had the pleasure of speaking with Lipika Goyal, MD, an assistant professor of medicine in the Department of Medicine at Massachusetts General Hospital. Dr Goyal joined us to discuss futibatinib (Lytgobi) in FGFR2-positive cholangiocarcinoma.

On September 30, 2022, the FDA granted accelerated approval to futibatinib, an FGFR inhibitor, in adult patients with previously treated, unresectable, locally advanced or metastatic intrahepatic cholangiocarcinoma with FGFR2 gene fusions or other rearrangements. The regulatory decision was based on findings from the phase 2 FOENIX*-CCA2 trial (TAS-120-101; NCT02052778), in which the agent elicited an overall response rate of 42%. All responders experienced partial responses. Additionally, the median duration of response (DOR) was 9.7 months, and 72% of patients experienced a DOR lasting at least 6 months.

In our exclusive interview, Dr Goyal highlighted the significance of this approval, key safety data from the FOENIX*-CCA2 trial, and the importance of biomarker testing in the cholangiocarcinoma population to detect FGFR, as well as other targets.


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