Onco-Summaries: Daily Oncology Updates at a Glance

09/12/2025

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• Senti Biosciences' SENTI-202 received the FDA's RMAT designation for hematologic malignancies

  
  

• Zydus and Formycon enter into an exclusive partnership for the Keytruda biosimilar, FYB206

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Senti Biosciences' SENTI-202 received the FDA's RMAT designation for hematologic malignancies (Ref)

The US FDA granted the Regenerative Medicine Advanced Therapy (RMAT) designation to Senti Biosciences' SENTI-202 (logic gated off-the-shelf CAR-NK cell therapy) for the treatment of relapsed/refractory hematologic malignancies, including AML.

• Timothy Lu, MD, PhD, Co-Founder and CEO, Senti Biosciences: “This significant FDA designation validates both the tremendous need for better treatments for R/R AML and the promise of SENTI-202 to transform the therapeutic landscape for this notoriously aggressive cancer. We are incredibly pleased with the exciting clinical progress we recently shared at the ASH conference on SENTI-202.”

• The designation was granted based on data from the ongoing Phase 1 trial of SENTI-202 in adult patients with relapsed or refractory CD33 and/or FLT3 expressing hematologic malignancies, including AML.

Zydus and Formycon enter into an exclusive partnership for the Keytruda biosimilar, FYB206 (Ref)

Zydus Lifesciences and Formycon entered into a strategic partnership for the exclusive licensing and supply of FYB206 (a biosimilar of Keytruda) in the USA and Canada market.

• Under the terms of this agreement, Formycon will develop, register, manufacture and supply FYB206

• Zydus Lifesciences will be responsible for the commercialization of FYB206 in the defined territories

• The BLA application is expected to be submitted to the US FDA in the near future