Oncology Updates - Key Oncology News

May 3rd Week, 2026

Regulatory Events 

🎯 Shanghai Junshi Biosciences Co Ltd’s NDA for toripalimab (anti-PD-1) + RemeGen Biosciences’ disitamab vedotin (HER2 ADC) for patients with HER2-expressing LA/M urothelial carcinoma was approved by the NMPA. (Ref 1)

❓ What are the clinical outcomes that support this approval?

Special Designations

⭐ The US FDA granted the Priority Review status to Bayer’s sevabertinib (HER2 TKI) for the first-line treatment of adult patients with LA/M NSCLC whose tumors have HER2 TKD activating mutations in patients with no prior therapy. (Ref 2)

❓ How is the regimen expected to impact the NSCLC Tx paradigm?

⭐ The US FDA granted the Rare Pediatric Disease Designation and Orphan Drug Designation to Canget BioTekpharma’s FL118 (novel camptothecin-derived small molecule) for the treatment of osteosarcoma. (Ref 3)

❓ What are the key unmet medical needs of this indication?

⭐ The US FDA granted the Orphan Drug Designation to Cullinan Therapeutics’ CLN-049 (FLT3 x CD3 T cell engager) for the treatment of R/R acute myeloid leukemia. (Ref 4)

❓ What are the key pros and cons associated with T cell engagers?

Clinical Events 

🔬 The Phase 3 OptiTROP-Breast03 trial of Kelun-Biotech Biopharmaceutical and Merck & Co./MSD’s sacituzumab tirumotecan (TROP2 ADC) vs investigator's choice of chemotherapy as first‑line treatment for unresectable LA/M triple‑negative breast cancer has met its primary endpoint of PFS. (Ref 5)

❓ How will this impact the asset’s positioning among other TROP2 ADC competitors?

🔬 Phase 3 TroFuse-005 trial of Merck & Co./MSD and Kelun-Biotech Biopharmaceutical’s sacituzumab tirumotecan (TROP2 ADC) vs treatment of physician’s choice met its primary endpoints of OS and PFS in certain patients with advanced or recurrent endometrial cancer. (Ref 6)

❓ What are the launch timeline estimates for this regimen?

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

🌐 References: 

1) https://www.globenewswire.com/news-release/2026/05/21/3299131/0/en/junshi-biosciences-announces-approval-of-toripalimab-nda-for-the-1st-line-treatment-of-her2-expressing-urothelial-carcinoma.html

2) https://www.bayer.com/en/us/news-stories/new-drug-application-for-hyrnuo

3) https://www.roswellpark.org/newsroom/202605-fl118-granted-fda-rare-pediatric-disease-designation-orphan-drug-designation

4) https://investors.cullinantherapeutics.com/news-releases/news-release-details/cullinan-therapeutics-receives-fda-orphan-drug-designation-cln

5) https://www.prnewswire.com/news-releases/kelun-biotech-announces-phase-iii-trial-of-sacituzumab-tirumotecan-sac-tmt-versus-chemotherapy-as-firstline-treatment-for-advanced-tnbc-met-primary-endpoint-of-pfs-302779066.html?tc=eml_cleartime

6) https://www.merck.com/news/merck-announces-trofuse-005-trial-evaluating-sacituzumab-tirumotecan-sac-tmt-met-primary-endpoints-of-overall-survival-os-and-progression-free-survival-pfs-in-certain-patients-with-advanced-or-r/