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Daiichi Sankyo/AstraZeneca's Enhertu receives FDA breakthrough therapy designation for breast cancer

 Last Update: 2022-05-12
 Source: Internet
 Author: User

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On April 27, AstraZeneca and Daiichi Sankyo jointly announced that the HER2 ADC drug Enhertu has been granted Breakthrough Therapy Designation (BTD) by the FDA for relapse or progression within six months of adjuvant therapy after receiving at least one prior systemic therapy Patients with unresectable or metastatic breast cancer with low HER2 expression (IHC1+orIHC2+/ISH-negative)

This is Enhertu's third BTD in breast cancer

DESTINY-Breast04 is a randomized, open-label, global, multicenter registry Phase III trial evaluating Enhertu (5.

Results showed that DESTINY-Breast04 met its primary endpoint, with Enhertu demonstrating superior PFS compared to SOC in previously treated HR-positive HER2-low metastatic breast cancer patients

The breakthrough of DESTINY-Breast04 research is expected to help AstraZeneca and Daiichi Sankyo use leading ADC drugs to cover the entire field of breast cancer treatment, including the exploration of different HER2 expression states and different HR expression states

Enhertu (HER2) Breast Cancer Development Program

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