Onco-Summaries: Daily Oncology Updates at a Glance

01/10/2025

The US FDA accepted the sBLA for Enhertu® followed by THP for HER2+ve early-stage Breast Cancer (Ref)

Daiichi Sankyo and AstraZeneca’s sBLA for famtrastuzumab deruxtecan-nxki (ENHERTU; HER2 ADC) followed by paclitaxel, trastuzumab and pertuzumab (THP) has been accepted for review by the US FDA for the neoadjuvant treatment of adult patients with HER2 +ve stage 2/3 breast cancer.

• The acceptance is based on results from the Phase 3 DESTINY-Breast11 trial

  
  

• The PDUFA date is May 18, 2026

Ensem Therapeutics' ETX-636 received the FDA Fast Track Designation for Advanced Breast Cancer (Ref)

The US FDA granted the Fast Track designation to Ensem Therapeutics' ETX-636 (pan mutant-specific allosteric PI3Kα inhibitor and degrader) for the treatment of adult patients with PIK3CA-mutant, HR+/HER2- advanced breast cancer.

• The Phase 1/2 NCT06993844 trial is ongoing to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary antitumor activity of ETX-636 in participants with advanced solid tumors harboring a PIK3CA mutation

• Dr. Shengfang Jin, CEO and Co-Founder, ENSEM: “Patients with advanced HR+/HER2- breast cancer harboring PIK3CA mutations have poor prognosis, and there is an unmet need for therapies targeting this population that are safer and more efficacious than the current FDA approved non-mutant selective treatments. We are appreciative that the FDA has recognized ETX-636 as a potentially important treatment for this indication and we remain laser-focused on demonstrating its benefit to patients in our current clinical trials.”