Onco-Summaries: Daily Oncology Updates at a Glance

17/07/2025

Johnson & Johnson received Priority Review for TAR-200 from the US FDA in high-risk non-muscle invasive bladder cancer (Ref)

• The US FDA granted Priority Review to Johnson & Johnson's NDA filed for TAR-200 (intravesical gemcitabine releasing system) for the treatment of BCG-unresponsive, high-risk NMIBC with carcinoma in situ (CIS), with or without papillary tumors.

  
  

  • The filing was based on results from the Phase 2b SunRISe-1 trial which demonstrated a CR of 82.4% with 52.9% patients remaining cancer-free at least one year or more after achievement of a CR

    
    

  • The majority of adverse reactions were mild and moderate and no systemic adverse reactions were reported

The US FDA granted the Breakthrough Therapy Designation to fam-trastuzumab deruxtecan-nxki + pertuzumab for breast cancer (Ref)

• AstraZeneca and Daiichi's fam-trastuzumab deruxtecan-nxki (ENHERTU; HER2 ADC) + pertuzumab has been granted the Breakthrough Therapy Designation by the US FDA for the first-line treatment of adult patients with unresectable or metastatic HER2+ve breast cancer

• The BTD was granted based on results from the Phase 3 DESTINY-Breast09 trial presented at the 2025 ASCO Annual Meeting

  
  

• Ken Takeshita, Global Head, R&D, Daiichi Sankyo: “This Breakthrough Therapy Designation provides further recognition of the potential benefit of ENHERTU in combination with pertuzumab in the first-line setting of HER2 positive metastatic breast cancer. If approved, ENHERTU will continue to redefine the treatment of metastatic breast cancer as these latest results from DESTINY-Breast09 demonstrate a median progression-free survival of more than three years when using ENHERTU plus pertuzumab in this disease setting, which is an improvement over the current standard of care that has been in place for more than a decade.”