Oncology Updates - Key Oncology News

August 1st Week, 2026

Regulatory Events 

🎯 The US FDA granted a Type C Statistical Methods Meeting to OS Therapies to review the 2.5yrs OS data from the Ph2b trial of daznelimgene lisbac (OST-HER2; HER2 targeted immunotherapy vaccine) in the prevention of recurrence in fully resected, pulmonary metastatic osteosarcoma (Ref) 

❓ How is OST-HER2 positioned in the osteosarcoma developmental landscape? 

Special Designations 

⭐ The US FDA granted a Fast Track Designation to Grand Pharmaceutical Group Limited's GPN01530-2 (fibroblast activating protein [FAP] targeted radionuclide-drug conjugate) for the diagnosis of solid tumors (Ref) 

❓ Which are the oncology indications with can be detected using FAP? 

⭐ The US FDA granted a Fast Track Designation to Celltrion Inc's CT-P73 (tissue factor–targeting ADC) for patients with recurrent and metastatic cervical cancer who have a history of platinum-based chemotherapy (Ref) 

❓ What is the current SOC for pre-treated cervical cancer in the US? 

⭐ The US FDA granted a Fast Track Designation to Phanes Therapeutics, Inc.'s spevatamig (CLDN18.2 x CD47 BsAb) in advanced and metastatic biliary tract carcinoma (BTC) (Ref) 

❓ In which other cancers are CLDN18.2 and CD47 targeted therapies being evaluated? 

⭐ The US FDA granted a Breakthrough Device Designation to Freenome’s SimpleScreen™ Lung (blood-based lung cancer screening test) for the proposed use in adults ages 50 - 80 who have at least a 20 pack-year smoking history and are not currently participating in guideline-recommended lung cancer screening (Ref) 

❓ What is the addressable market size for SimpleScreen™? 

Clinical Updates 

🔬The Ph3 REZILIENT3 trial of Cullinan Therapeutics and Taiho Oncology, Inc.'s zipalertinib (irreversible EGFR inhibitor) + platinum-based chemo vs chemo alone in 1L LA/M EGFR ex20ins mutation NSCLC met its primary endpoint of PFS at a planned interim analysis (Ref) 

❓ What is the expected launch timeline for zipalertinib in the US? 

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

🌐 References:

1) https://ir.ostherapies.com/news-events/press-releases/detail/123/os-therapies-granted-u-s-fda-type-c-statistical-methods

2) https://ea-cdn.eurolandir.com/press-releases-attachments/4165371/HKEX-EPS_20260809_12277954_0.PDF

3) https://www.celltrion.com/ko-kr/company/media-center/press-release/4887

4) https://www.phanesthera.com/news/phanes-therapeutics-receives-fda-fast-track-designation-for-spevatamig-in-advanced-and-metastatic-biliary-tract-carcinoma/

5) https://www.freenome.com/newsroom/fda-grants-breakthrough-device-designation-to-freenomes-blood-based-simplescreen-lung-cancer-screening-test/

6) https://investors.cullinantherapeutics.com/news-releases/news-release-details/zipalertinib-plus-chemotherapy-meets-primary-endpoint