Onco-Summaries: Daily Oncology Updates at a Glance

24/09/2025

AstraZeneca and Daiichi's trastuzumab deruxtecan + pertuzumab received priority review status for first-line HER2+ve breast cancer (Ref)

The US FDA accepted and granted Priority Review to AstraZeneca and Daiichi Sankyo’s sBLA for trastuzumab deruxtecan (Enhertu; HER2 ADC) + pertuzumab for the first-line Tx of adult patients with unresectable or metastatic HER2-positive breast cancer.

• The PDUFA date is anticipated during Q1'26

  
  

• The sBLA was based on results from the Ph3 DESTINY-Breast09 trial, in which the combo reduced the risk of disease progression or death by 44% vs a taxane, trastuzumab and pertuzumab (THP)

Artios' alnodesertib received the FDA Fast Track designation for ATM-negative mCRC (Ref)

The US FDA granted the fast track designation to Artios Pharma's alnodesertib (ATR inhibitor) + low dose irinotecan (chemotherapeutic agent) for the treatment of adult patients with ATM-negative mCRC in the third-line setting.

• The designation is based on results from the ongoing Phase 1/2a STELLA trial in which the combo showed promising efficacy and a favorable safety profile

  
  

• Mike Andriole, CEO, Artios: “The Fast Track designation for alnodesertib underscores its first-in-class potential for third-line mCRC patients with ATM-negative tumors. Approximately 3,000 patients with ATM-negative third-line mCRC succumb to this disease annually in the United States, with no treatment options that specifically address this protein deficiency. Alnodesertib has the potential to be the first treatment specifically for this invariably lethal disease.

  
  

  • Additionally, we are encouraged by the durable responses this program has demonstrated across other tumor types, highlighting its ability to target replication stress across a range of solid tumors.”