(Lung Cancer) anti-HER2 antibody-drug conjugate Files Supplemental Application for Second-Line Treatment
(Lung Cancer) anti-HER2 antibody-drug conjugate Files Supplemental Application for Second-Line Treatment
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(Lung Cancer) anti-HER2 antibody-drug conjugate Files Supplemental Application for Second-Line Treatment
- December 21, 2022
- 1 min read
On December 13, 2022, Daiichi Sankyo announced that HER2 antibody drug anti-HER2 antibody-drug conjugate filed a supplemental application for second-line treatment of HER2-mutant non-small cell lung cancer.
This application was based on the results of the DESTINY-Lung02 Phase II clinical trial and the DESTINY-Lung01 trial. The DESTINY-Lung02 trial enrolled previously treated HER2-mutant non-small cell lung cancer patients (N=80), divided into anti-HER2 antibody-drug conjugate 5.4 mg/kg (N=52) and anti-HER2 antibody-drug conjugate 6.4 mg/kg (N=28) groups for efficacy and safety evaluation. The trial results were presented at ESMO 2022 in September. The DESTINY-Lung01 trial evaluated the efficacy and safety of anti-HER2 antibody-drug conjugate 6.4 mg/kg in previously treated advanced non-small cell lung cancer patients (N=91).
In the press release, Daiichi Sankyo stated that by providing a new second-line treatment option for HER2-mutant non-small cell lung cancer patients, the company hopes to contribute to the care of more patients.
Additionally, in September 2022, anti-HER2 antibody-drug conjugate was designated as an orphan drug for HER2 mutation-positive, unresectable or recurrent non-small cell lung cancer patients.
Source: https://www.daiichisankyo.co.jp/files/news/pressrelease/pdf/202212/20221213_J.pdf
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