Oncology Updates - Key Oncology News

January 1st Week, 2026

Clinical Events

🔬 Per primary analysis from the Phase 3 HERIZON-GEA-01 trial, Jazz Pharmaceuticals, BeOne Medicines and Zymeworks Inc.'s zanidatamab (bispecific HER2-directed antibody) + chemo ± BeOne Medicines' tislelizumab (anti-PD-1) met the PFS endpoint as a first-line treatment of HER2+, locally advanced or metastatic gastroesophageal adenocarcinoma. (Ref 1)

❓ What are the current survival benchmarks for this indication?

Special Designations

⭐ The US FDA and China's CDE granted the breakthrough therapy designation to Bayer's sevabertinib (tyrosine kinase inhibitor) as a first-line therapy in patients with locally advanced or metastatic NSCLC with HER2 activating mutations. (Ref 2)

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

⭐ The US FDA granted the breakthrough therapy designation to Revolution Medicines' zoldonrasib (RAS(ON) G12D-selective inhibitor) for the treatment of adult patients with KRAS G12D-mutated locally advanced or metastatic NSCLC who have been previously treated with anti-PD-1/PD-L1 therapy and platinum-based chemotherapy. (Ref 3)

❓ What were the clinical outcomes that supported this designation?

⭐ The US FDA granted the fast track designation to 858 Therapeutics' ETX-19477 (PARG inhibitor) for the treatment of adult patients with BRCA-mutated, platinum-resistant, high-grade serous ovarian cancer (HGSOC). (Ref 4)

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

⭐ The US FDA granted the orphan drug designation to Arbele's ARB1002 (CDH17 targeting ADC) for the treatment of pancreatic cancer. (Ref 5)

❓ Which are the other key ADCs being evaluated for pancreatic cancer?

⭐ The US FDA and the EMA granted the orphan drug designation to Curadel Pharma's CPI-008 (cRGD-ZW800-1; integrin-targeted, zwitterionic imaging drug) for margin detection of pancreatic cancer during surgery. (Ref 6)

❓ Who are the other key players developing imaging drugs?

⭐ The US FDA granted the orphan drug designation to Cellenkos, Inc.'s CK0804 (CXCR4hi Treg therapeutic) for treatment of myelofibrosis. (Ref 7)

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

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

🌐 References:

1) https://investor.jazzpharma.com/news-releases/news-release-details/ziiherar-zanidatamab-hrii-combinations-achieve-unprecedented

2) https://www.bayer.com/media/en-us/bayer-receives-breakthrough-therapy-designation-in-the-us-and-china-for-sevabertinib-as-a-first-line-treatment-for-patients-with-her2-mutant-non-small-cell-lung-cancer/

3) https://www.globenewswire.com/news-release/2026/01/08/3215331/0/en/Revolution-Medicines-Announces-FDA-Breakthrough-Therapy-Designation-for-Zoldonrasib.html

4) https://www.businesswire.com/news/home/20260108319598/en/858-Therapeutics-Announces-FDA-Fast-Track-Designation-for-PARG-Inhibitor-ETX-19477-for-the-Treatment-of-Patients-with-BRCA-Mutated-Platinum-Resistant-Ovarian-Cancer

5) https://www.prnewswire.com/news-releases/arbele-receives-fda-orphan-drug-designation-for-arb1002-an-anti-cdh17-antibodydrug-conjugate-for-the-treatment-of-pancreatic-cancer-302654913.html

6) https://www.curadelpharma.com/2026/01/07/fda-and-ema-grant-orphan-drug-designation-for-curadels-cpi-008-a-targeted-zwitterionic-imaging-drug-for-pancreatic-cancer/

7) https://www.prnewswire.com/news-releases/fda-grants-orphan-drug-designation-to-cellenkos-ck0804-treg-therapy-for-treatment-of-myelofibrosis-302653827.html