Onco-Summaries: Daily Oncology Updates at a Glance

20/11/2025

Taiho and Cullinan initiated the rolling submission of a NDA for zipalertinib in EGFR-mutant NSCLC (Ref)

Taiho and Cullinan Therapeutics have initiated the rolling submission of a NDA to the US FDA seeking accelerated approval of zipalertinib (EGFR tyrosine kinase inhibitor) for the treatment of patients with locally advanced or metastatic NSCLC with EGFR ex20ins mutations who have previously received platinum-based systemic chemotherapy.

• The submission is based on the primary efficacy data from the Ph1/2 REZILIENT1 trial of zipalertinib monotherapy in patients with NSCLC harboring EGFR ex20ins mutations who have received prior therapy

  
  

• Zipalertinib previously received the FDA Breakthrough Therapy Designation in 2021

  
  

• The companies anticipate completion of the NDA submission in Q1'26 with an associated request for priority review