Onco-Summaries: Daily Oncology Updates at a Glance

16/03/2026

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• AstraZeneca’s perioperative durvalumab regimen received EC approval for early gastric and gastroesophageal cancers

  
  

• Telix resubmitted NDA to the US FDA for TLX101-Px brain cancer imaging candidate

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AstraZeneca’s perioperative durvalumab regimen received EC approval for early gastric and gastroesophageal cancers (Ref)

The EC granted approval to AstraZeneca’s durvalumab (anti-PD-L1) + standard-of-care FLOT chemotherapy for the treatment of adult patients with resectable, early-stage and locally advanced (Stages II, III, IVA) gastric and gastroesophageal junction (GEJ) cancers.

• The regimen includes two cycles of durvalumab + chemotherapy before and after surgery, followed by durvalumab monotherapy

• The approval follows the positive CHMP opinion and is based on the results from the Phase 3 MATTERHORN trial

  
  

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Telix resubmitted NDA to the US FDA for TLX101-Px brain cancer imaging candidate (Ref)

Telix completed the resubmission of a NDA to the US FDA for TLX101-Px (Floretyrosine F 18 or 18F-FET; an investigational PET[2] imaging agent) for the characterization of recurrent or progressive glioma (brain cancer) from treatment related changes in both adult and pediatric patients.

• The resubmitted NDA includes additional data requested by the FDA

• Dr. David N. Cade, CMO, Telix Group: “We appreciate the FDA’s recognition of the critical unmet need to improve the diagnosis and management of glioma, particularly in the post-treatment setting. Our resubmission is supported by an extensive and compelling data set – particularly so for an orphan indication. We are grateful to our global clinical collaborators, who share our commitment to ensuring patients in the U.S. can benefit from this important patient management tool.”

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