Onco-Summaries: Daily Oncology Updates at a Glance

29/12/2025

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• HUTCHMED's fanregratinib received priority review status in China for second-line intrahepatic cholangiocarcinoma

• Genmab discontinued the clinical development of acasunlimab following a portfolio review

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HUTCHMED's fanregratinib received priority review status in China for second-line intrahepatic cholangiocarcinoma (Ref)

China's NMPA accepted and granted priority review status to HUTCHMED Limited's NDA for fanregratinib (FGFR 1/2/3 inhibitor) for the treatment of adult patients with advanced, metastatic or unresectable intrahepatic cholangiocarcinoma with FGFR-2 fusion or rearrangement who have previously received systemic therapy.

• The NDA was filed based on data from a single-arm, multi-center, open-label, Phase 2 NCT04353375 registration study in China

Genmab discontinued the clinical development of acasunlimab following a portfolio review (Ref)

Genmab announced the discontinuation of further clinical development of its acasunlimab (PD-L1 x 4-1BB BsAb).

• This decision was made as part of Genmab’s strategic focus on the most value‑creating opportunities in its late‑stage portfolio and following a thorough assessment of the evolving competitive landscape

• Genmab will concentrate resources on programs with the highest potential impact, including epcoritamab, petosemtamab and rinatabart sesutecan

• Jan van de Winkel, CEO, Genmab: “After careful consideration, we have decided to discontinue the acasunlimab program. Although the data have been encouraging, the compelling opportunities we see in our late‑stage pipeline led us to focus our investments where we believe we can deliver the greatest benefit for patients and shareholders. We are highly energized by the momentum of EPKINLY, petosemtamab and Rina‑S, and we remain committed to executing these programs with speed and rigor.”