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Oncology Updates - Key Oncology News


April 1st Week, 2026




Regulatory Events 


🎯 The EC approved Merck & Co./MSD's pembrolizumab (anti-PD-1) + paclitaxel ± bevacizumab for the Tx of platinum-resistant epithelial ovarian, fallopian tube or primary peritoneal carcinoma in adults with PD-L1 CPS ≥1, and who have received one or two prior systemic Tx regimens (Ref 1) 


❓ How is the regimen positioned in EU market landscape?


 


Special Designations  



⭐ The US FDA granted the breakthrough therapy designation to Fore Biotherapeutics' plixorafenib (BRAF inhibitor) for the Tx of adults with BRAF V600E+ high-grade glioma (Ref 2) 


❓ What are plixorafenib’s differentiators vs other key assets in the pipeline landscape?


 


⭐ The US FDA granted the fast track designation to Context Therapeutics' CTIM-76 (CLDN6 x CD3 BsAb) for the Tx of PROC in patients that have received all standard of care therapies (Ref 3) 


❓ What is the addressable patient population for this regimen? 


 


⭐ The US FDA granted the fast track designation to A2 Biotherapeutics, Inc.'s A2B543 (logic-gated CAR T-therapy) for the Tx of germline heterozygous HLA-A02 adults with recurrent LA/M solid tumors that express MSLN and have lost HLA-A02 expression (Ref 4) 


❓ Are there any planned registrational trials for A2B543?



⭐ The US FDA granted the Regenerative Medicine Advanced Therapy designation to Caribou Biosciences' CB-011 (allogeneic anti-BCMA CAR-T) for relapsed or refractory multiple myeloma (Ref 5) 


❓ Which are the key competitors to CB-011 in the MM landscape?


 


⭐ The US FDA granted the fast track designation to Zymeworks Inc.’s ZW191 (FRα-targeting ADC) for the Tx of patients with advanced or metastatic PROC (Ref 6) 


❓ What is the expected launch timeline for ZW191?


 


⭐ The US FDA accepted the NDA and granted priority review status to Elevar Therapeutics Inc's lirafugratinib (FGFR2 inhibitor) for the Tx of patients with cholangiocarcinoma with FGFR2 fusions or rearrangements who have received prior therapy (Ref 7)


❓ How is lirafugratinib positioned within the development landscape of cholangiocarcinoma? 


 


Clinical Events 


🔬 AstraZeneca's Phase 3 EMERALD-3 trial of durvalumab (anti-PD-L1) + tremelimumab (anti-CTLA-4) + lenvatinib + TACE demonstrated a statistically significant and clinically meaningful improvement in PFS vs TACE alone for patients with unresectable HCC eligible for embolization (Ref 8)


❓ What is the expected regulatory approval timeline for this regimen?


 

To know answers to these questions and for additional insights, write to us support@oncofocus.com. 


 


🌐 References:



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