Onco-Summaries: Daily Oncology Updates at a Glance

07/07/2025

SIR-Spheres® Y-90 Resin Microspheres received FDA approval for HCC (Ref)

• The US FDA approved Sirtex Medical's SIR-Spheres Y-90 resin microspheres for the Tx of unresectable HCC

  • The approval is based on the results from the prospective, multi-center, open-label DOORwaY90 trial

    
    

    • DOORwaY90 met its prespecified primary endpoints with a ORR of 98.5%; the median DoR exceeded 300 days

      
      

  • Matt Schmidt, CEO, Sirtex: "The expanded indication makes SIR-Spheres® the only Y-90 treatment approved in the U.S. for both HCC and mCRC. This milestone reflects our ongoing commitment to delivering flexible, personalized therapies—with multiple dose options available daily—that empowers physicians to treat patients when and where it works best."

Anktiva received MHRA approval for NMIBC CIS (Ref)

• The UK MHRA granted marketing authorization for ImmunityBio's nogapendekin alfa inbakicept-pmln (ANKTIVA; lymphocyte-stimulating agent) in combination with BCG for the Tx of BCG-Unresponsive Non-Muscle Invasive Bladder Cancer Carcinoma In Situ

• Dr. Patrick Soon-Shiong, Founder, Executive Chairman and Global Chief Scientific and Medical Officer, ImmunityBio: “With the MHRA’s authorization of ANKTIVA plus BCG, we can now offer our immunotherapy outside the U.S. to help patients with a disease that, if not effectively treated, can lead to bladder removal. This immune-boosting, lymphocyte-stimulating agent, the first of its kind, is central to our Cancer BioShield platform, which is designed to restore immune function and support long-term disease control.”

  
  

• ImmunityBio has also submitted regulatory applications to the EMA to expand availability of ANKTIVA across the 27 EU member states, as well as Iceland, Norway and Liechtenstein