파트리투맙 데룩스테칸 Patritumab deruxtecan (HER3-DXd, U3-1402)

https://www.medipana.com/health/view.php?news_idx=320912

'파트리투맙 데룩스테칸' FDA 승인신청 접수

 

 

MSD와 다이이찌산쿄가 공동개발하는 항HER3 ADC(항체약물결합체) '파트리투맙 데룩스테칸'(patritumab deruxtecan)이 미국 FDA에 EGFR 변이를 지닌 비소세포폐암에 관한 3차 치료제로 승인신청이 접수됐다.

대상은 EGFR 변이를 지닌 국소진행 또는 전이성 비소세포폐암에 관한 3차 치료로, FDA로부터 우선심사 지정을 받았다. 심사종료 목표일은 2024년 6월 26일로 설정됐다.

 

 

https://ascopubs.org/doi/10.1200/JCO.23.01476

After tumor progression with EGFR TKI therapy and PBC in patients with EGFR-mutated NSCLC, HER3-DXd once every 3 weeks demonstrated clinically meaningful efficacy with durable responses, including in CNS metastases. A phase III trial in EGFR-mutated NSCLC after progression on an EGFR TKI is ongoing (HERTHENA-Lung02; ClinicalTrials.gov identifier: NCT05338970).

 

 

https://clinicaltrials.gov/study/NCT05338970#more-information

ClinicalTrials.gov

Patritumab deruxtecan (HER3-DXd, U3-1402) is an antibody-drug conjugate (ADC) comprising an anti-HER3 mAb linked to a topoisomerase I inhibitor that is in clinical development for patients with NSCLC, metastatic breast cancer, and colorectal cancer.

The primary objective of the current study is to compare the efficacy of patritumab deruxtecan versus platinum-based chemotherapy, as measured by progression-free survival (PFS) and the key secondary endpoint of overall survival (OS), in participants with metastatic or locally advanced NSCLC with an EGFR-activating mutation (exon 19 deletion or L858R) after failure of third-generation (eg, osimertinib, lazertinib, aumolertinib, alflutinib) EGFR TKI therapy.

 

 

https://www.onclive.com/view/patritumab-deruxtecan-bla-receives-priority-review-in-nsclc

Patritumab Deruxtecan BLA Receives Priority Review in NSCLC

 

 

https://www.cancernetwork.com/view/patritumab-deruxtecan-yields-meaningful-enduring-activity-in-egfr-nsclc

Patritumab Deruxtecan Yields Meaningful, Enduring Activity in EGFR+ NSCLC