Oncology Updates - Key Oncology News

January 2nd Week, 2026

Regulatory Events

🎯 Summit Therapeutics, Inc. has submitted a biologics license application to the US FDA seeking approval for Akeso Biopharma & Summit's ivonescimab (PD-1 x VEGF BsAb) + chemotherapy in second-line or later treatment of patients with EGFR-mutated locally advanced or metastatic non-squamous NSCLC. (Ref 1)

❓ What are the launch timeline estimates for the regimen in this indication?

Special Designations

⭐ The US FDA granted the regenerative medicine advanced therapy designation to Eureka Therapeutics, Inc' ECT204 (GPC3-targeting CAR T-cell therapy) for the treatment of patients with advanced hepatocellular carcinoma. (Ref 2)

❓ What were the clinical outcomes that supported this designation?

⭐ The US FDA granted the breakthrough therapy designation to Ipsen's IPN60340 (anti-BTN3A) in combination with venetoclax and azacitidine in first line unfit acute myeloid leukemia. (Ref 3)

❓ Which are the other key promising assets being evaluated in this indication?

⭐ The US FDA granted fast track designation to Nanjing Leads Biolabs' opamtistomig (PD-L1 x 4-1BB BsAb) for the treatment of extra-pulmonary neuroendocrine carcinoma (Ref 4).

❓ Which are the other key bispecifics being evaluated for this indication?

⭐ The US FDA granted the orphan drug designation to Novita Pharmaceuticals' NP-G2-044 (fascin inhibitor) for the treatment of pancreatic cancer. (Ref 5)

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

Deals And Collaborations

🤝 AbbVie & RemeGen Biosciences announced an exclusive licensing agreement for the development, manufacturing and commercialization of RemeGen's RC148 (PD-1 x VEGF BsAb). (Ref 6)

❓ Which are the other key PD(L)-1 x VEGF targeting assets being developed under licensing agreements?

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

🌐 References:

1) https://smmttx.com/news/press-releases/news-details/2026/Summit-Therapeutics-Announces-Submission-of-Biologics-License-Application-BLA-to-U-S--FDA-Seeking-Approval-for-Ivonescimab-in-Combination-with-Chemotherapy-in-2L-Treatment-of-Patients-with-EGFRm-NSCLC/default.aspx

2) https://www.eurekatherapeutics.com/press-releases/2026/u-s-fda-grants-rmat-designation-to-ect204-an-artemis-car-abtcr-t-cell-therapy-for-advanced-hepatocellular-carcinoma/

3) https://www.ipsen.com/press-release/u-s-fda-grants-ipsens-ipn60340-ict01-breakthrough-therapy-designation-in-first-line-unfit-acute-myeloid-leukemia-3218133

4) https://m.leadsbiolabs.com/news/detail?id=169

5) https://www.prnewswire.com/news-releases/novita-pharmaceuticals-announces-fda-orphan-drug-designation-granted-to-np-g2-044-for-the-treatment-of-pancreatic-cancer-302658088.html

6) https://news.abbvie.com/2026-01-12-AbbVie-and-RemeGen-Announce-Exclusive-Licensing-Agreement-to-Develop-A-Novel-Bispecific-Antibody-for-Advanced-Solid-Tumors