Daiichi Sankyo and AstraZeneca’s Enhertu Receives the US FDA’s Approval for the Treatment of HER2 Mutant Metastatic Non-Small Cell Lung Cancer
- 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
Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at firstname.lastname@example.org.