Onco-Summaries: Daily Oncology Updates at a Glance

07/05/2026

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• Pierre Fabre secures FDA alignment to resubmit tabelecleucel BLA with updated ALLELE Phase 3 data for EBV+ PTLD

  
  

• Halozyme Announces Global Collaboration and License Agreement with GSK for the first ADC-focused ENHANZE, targeting subcutaneous oncology formulations and milestone-driven royalties

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Pierre Fabre secures FDA alignment to resubmit tabelecleucel BLA with updated ALLELE Phase 3 data for EBV+ PTLD (Ref)

Pierre Fabre Pharmaceuticals (PFP) aligned with the FDA on a path forward for resubmission of the Biologic License Application (BLA) for tabelecleucel, an allogeneic T‑cell therapy for relapsed/refractory Epstein‑Barr Virus positive post‑transplant lymphoproliferative disease (EBV+ PTLD)

PFP will provide an updated dataset with more patients and longer follow‑up from the pivotal Phase 3 ALLELE study, covering adults and children ≥2 years with EBV+ PTLD after solid organ or hematopoietic cell transplant

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Halozyme Announces Global Collaboration and License Agreement with GSK for the first ADC-focused ENHANZE, targeting subcutaneous oncology formulations and milestone-driven royalties (Ref)

Halozyme entered a global collaboration and license agreement with GSK to use its ENHANZE® drug delivery technology for subcutaneous administration of multiple oncology targets, including antibody-drug conjugates (ADCs). GSK also has options for additional future targets

This marks Halozyme’s first ENHANZE® agreement involving ADCs, with the first clinical trial expected to begin in 2026

GSK will provide an upfront payment, milestone payments, and royalties to Halozyme on net sales of products incorporating ENHANZE

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