Onco-Summaries: Daily Oncology Updates at a Glance

03/02/2026

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• Relay Therapeutics' zovegalisib + fulvestrant received the FDA breakthrough therapy designation for breast cancer

  
  

• The US FDA granted priority review status to Datroway for the treatment of TNBC

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Relay Therapeutics' zovegalisib + fulvestrant received the FDA breakthrough therapy designation for breast cancer (Ref)

The US FDA granted the breakthrough therapy designation to Relay Therapeutics' zovegalisib (PI3Kα inhibitor) + fulvestrant for the treatment of adults with PIK3CA mutant, HR positive, HER2-negative, locally advanced or metastatic breast cancer following recurrence or progression on or after treatment with a CDK4/6 inhibitor.

• BTD for zovegalisib was supported by clinical data generated to date from the Phase 1/2 ReDiscover trial

• Don Bergstrom, M.D., Ph.D., President of R&D, Relay Therapeutics: “Approximately 40% of patients with HR+/HER2- advanced breast cancer harbor PIK3CA mutations, and most experience disease recurrence or progression following treatment with CDK4/6 inhibitors, leaving limited therapeutic options.

  
  

  • This Breakthrough Therapy designation underscores the FDA’s recognition of the potential of zovegalisib in combination with fulvestrant to meaningfully improve outcomes for these patients, reinforcing the impact of the encouraging clinical evidence we have demonstrated to date. We look forward to continuing to collaborate closely with the FDA as we work to advance this program as efficiently as possible for patients.”

The US FDA granted priority review status to Datroway for the treatment of TNBC (Ref)

AstraZeneca and Daiichi Sankyo’s sBLA for datopotamab deruxtecan (Datroway; TROP2 ADC) has been accepted and granted Priority Review in the US for the treatment of adult patients with unresectable or metastatic triple-negative breast cancer (TNBC) who are not candidates for PD-1/PD-L1 inhibitor therapy.

• The PDUFA date is anticipated during the second quarter of 2026

• The sBLA is being reviewed under Project Orbis

• The sBLA is based on results from the Phase III  TROPION-Breast02 trial