Daiichi Sankyo And AstraZeneca's Supplemental Biologics License Application For ENHERTU® Accepted And Granted Priority Review By The FDA For Patients With Metastatic HER2 Positive Solid Tumors
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The FDA has accepted and granted priority review for Daiichi Sankyo and AstraZeneca's supplemental Biologics License Application for ENHERTU to treat metastatic HER2 positive solid tumors. The application is supported by results from the DESTINY-PanTumor02 trial and additional ENHERTU data. The review will be conducted under the FDA's Real Time Oncology Review and Project Orbis, and if approved, ENHERTU could become the first HER2 directed treatment and antibody drug conjugate with a tumor agnostic indication.
January 29, 2024 | 7:19 am
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POSITIVE IMPACT
AstraZeneca's ENHERTU, developed in collaboration with Daiichi Sankyo, has been granted priority review by the FDA for treating metastatic HER2 positive solid tumors, potentially becoming a first-in-class treatment.
The priority review status by the FDA is a positive signal for AstraZeneca, indicating a faster review process and a higher likelihood of approval. This could lead to a significant competitive advantage in the oncology market and potentially boost sales for AstraZeneca if ENHERTU is approved.
CONFIDENCE 85
IMPORTANCE 75
RELEVANCE 80
POSITIVE IMPACT
Daiichi Sankyo's collaboration with AstraZeneca on ENHERTU has received priority review from the FDA for the treatment of metastatic HER2 positive solid tumors, marking a significant milestone for the company.
The FDA's acceptance of the supplemental Biologics License Application with priority review for ENHERTU is a strong endorsement of Daiichi Sankyo's research and development efforts. Approval could lead to increased revenue and enhanced market positioning for Daiichi Sankyo in the oncology sector.
CONFIDENCE 85
IMPORTANCE 75
RELEVANCE 80