Daiichi Sankyo and AstraZeneca’s Enhertu Receives the US FDA’s Approval for the Treatment of HER2 Mutant Metastatic Non-Small Cell Lung Cancer

Shots:

The approval was based on the results from the P-II (DESTINY-Lung02) trial evaluating the safety & efficacy of Enhertu (5.4mg/kg & 6.4mg/kg) in patients (n=101) with HER2 mutant mNSCLC. The US FDA has also approved companion diagnostic tests to detect HER2 mutation in lung tumor tissue & plasma
The results demonstrated an ORR of 57.7% in patients who previously received a systemic therapy as assessed by BICR along with a CR of 1.9%, PR of 55.8% & a mDoR of 8.7mos.
Enhertu is a HER2-directed ADC developed using Daiichi Sankyo’s proprietary DXd ADC technology. Daiichi Sankyo & AstraZeneca will ensure access to medication and necessary financial support to the US patients who are prescribed Enhertu

Ref: Businesswire | Image: Daiichi Sankyo

Daiichi Sankyo and AstraZeneca’s Enhertu Receives the US FDA’s Approval for the Treatment of HER2 Mutant Metastatic Non-Small Cell Lung Cancer

Shots:

The approval was based on the results from the P-II (DESTINY-Lung02) trial evaluating the safety & efficacy of Enhertu (5.4mg/kg & 6.4mg/kg) in patients (n=101) with HER2 mutant mNSCLC. The US FDA has also approved companion diagnostic tests to detect HER2 mutation in lung tumor tissue & plasma
The results demonstrated an ORR of 57.7% in patients who previously received a systemic therapy as assessed by BICR along with a CR of 1.9%, PR of 55.8% & a mDoR of 8.7mos.
Enhertu is a HER2-directed ADC developed using Daiichi Sankyo’s proprietary DXd ADC technology. Daiichi Sankyo & AstraZeneca will ensure access to medication and necessary financial support to the US patients who are prescribed Enhertu

Ref: Businesswire | Image: Daiichi Sankyo