Onco-Summaries: Daily Oncology Updates at a Glance

10/02/2026

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• Abbisko Therapeutics' irpagratinib received the FDA fast track designation for certain patients with HCC

• Merck's Keytruda/Keytruda Qlex regimen received FDA approval for PD-L1 positive Ovarian Cancer

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Abbisko Therapeutics' irpagratinib received the FDA fast track designation for certain patients with HCC (Ref)

The US FDA granted the fast track designation to Abbisko Therapeutics' irpagratinib (FGFR4 inhibitor) for the treatment of patients with hepatocellular carcinoma (HCC) with FGF19 overexpression who have been previously treated with immune checkpoint inhibitors (ICIs) and multi-targeted kinase inhibitors (mTKls) therapies.

• The designation is primarily based on positive results from a Phase 1 clinical study presented at the 2024 ESMO Annual Congress

• In May 2025, irpagratinib was granted Breakthrough Therapy Designation (BTD) by the Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA)

Merck's Keytruda/Keytruda Qlex regimen received FDA approval for PD-L1 positive Ovarian Cancer (Ref)

The US FDA approved Merck & Co/MSD's Keytruda (pembrolizumab; anti-PD-1) as well as Keytruda Qlex (pembrolizumab and berahyaluronidase alfa-pmph subcutaneous product) in combination with paclitaxel, with or without bevacizumab, for adult patients with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal carcinoma whose tumors express PD-L1 (CPS≥1) as determined by an FDA-authorized test, and who have received one or two prior systemic treatment regimens.

• The FDA also approved the PD-L1 IHC 22C3 pharmDx (Agilent Technologies, Inc) as a companion diagnostic device to identify patients with epithelial ovarian, fallopian tube, or primary peritoneal carcinoma whose tumors express PD-L1 (CPS≥1) for treatment with pembrolizumab.

• The approval was granted based on positive results from the Phase 3 KEYNOTE-B96 (NCT05116189) trial