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Astrazeneca
NEWS

AstraZeneca Secures the US FDA Approval of Imfinzi as a Perioperative Therapy for G/GEJ Cancers

Shots: FDA has approved perioperative Imfinzi for adults with resectable, early-stage & locally advanced (Stages II, III, IVA) G/GEJ cancers, with submission reviewed under Project Orbis & based on P-III (MATTERHORN) trial; regulatory review is ongoing in the EU & Japan  In the trial, Pts (n=948) received Imfinzi (1500mg) + FLOT or PBO + FLOT for Q4W ×…
November 26, 2025

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Astrazeneca
NEWS

AstraZeneca Reports P-III (MATTERHORN) Trial Data of Imfinzi as Perioperative Therapy for Stage II-IVA G/GEJ Cancers

Shots: AstraZeneca has reported P-III (MATTERHORN) trial data assessing perioperative Imfinzi + FLOT (fluorouracil, leucovorin, oxaliplatin, & docetaxel) vs PBO + FLOT in 948 pts with stage II-IVA G/GEJ cancers Pts received Imfinzi (1500mg) + FLOT or PBO + FLOT for Q4W × 2 cycles before surgery followed by Imfinzi or PBO for Q4W × 12…
March 7, 2025

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BeiGene
NEWS

BeiGene’s Tevimbra Plus Chemotherapy Secures the US FDA’s Approval as a 1L Treatment of G/GEJ Cancers 

Shots:    The US FDA has approved Tevimbra + Pt & fluoropyrimidine-based CT as a 1L treatment of inoperable or metastatic HER2- G/GEJ adenocarcinoma with PD-L1 (≥1) expression. Another BLA for 1L locally advanced unresectable or metastatic ESCC is under review  Approval was based on P-III (RATIONALE-305) study of Tevimbra + CT vs PBO in patients…
December 26, 2024

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