Jan 17, 2022
AstraZeneca's and Daiichi Sankyo's Enhertu received priority status for HER-2 positive breast cancer with prior treatment
AstraZeneca and Daiichi Sankyo announced that the US FDA had accepted the supplemental Biologics Licence Application (sBLA) of Enhertu (trastuzumab deruxtecan) to treat patient HER-2 positive breast cancer who were previously treated with anti-HER2-regimen. The application has also received a priority review.
Enhertu is a HER2-directed antibody-drug conjugate (ADC). It reduced the risk of disease progress or death by 72% versus trastuzumab emtansine.
The sBLA is based on the Phase DESTINY-Breast03 trial. Patients who were previously treated with trastuzumab and a taxane for HER2-positive unresectable and/or metastatic breast cancer were included in the trial. The risk of disease progression or death is reduced by 72% compared to T-DM1. After one year of treatment, 94.1% were alive in the Enhertu arm compared to 85.9% in the T-DM1 arm. The objective response rate was 79.7% in the Enhertu arm versus 34.2% in the T-DM1 arm.
The drug is in different phases of development for gastric, lung, and colorectal cancer.
Gilead's Trodelvy approved for TNBC in Europe; provides a new option for 3L patients
Approval is based on Phase 3 ASCENT Study
Trodelvy showed improvement in the overall survival versus physician's choice of chemotherapy
Trodelvy (sacituzumab govitecan), a Trop-2-directed antibody-drug conjugate, is approved for treating triple-negative breast cancer patients. Trodelvy is indicated for patients who received two prior lines of therapy, one of which is indicated for advanced disease.
The approval is based on the Phase 3 ASCENT Study; Trodelvy demonstrated improvement in the overall survival versus chemotherapy. The risk of death was reduced by 49%; the overall survival was 11.8 months in the Trodelvy arm versus 6.9 months in patients on chemotherapy. The median progression survival improved to 4.8 months from 1.7 months (observed in physician's choice of chemotherapy).
Trodelvy was previously approved in Australia, Canada, Great Britain, Switzerland, and the United States for TNBC.
Merck's Keytruda was approved in Europe for certain patients with TNBC
European Commission has approved Keytruda in combination with chemotherapy in patients with triple-negative breast cancer. The drug is approved for a locally recurrent unresectable or metastatic tumor, express PD L1, and patients who have not received prior chemotherapy.
The drug was approved based on Phase 3 KEYNOTE-355 Study, in which Keytruda demonstrated statistically significant improvement in overall survival. This is the first breast cancer indication of Keytruda approved within Europe.
The approval is based on the Phase 3 KEYNOTE-355 trial; Keytruda, combined with chemotherapy, reduced the risk of death by 27% versus chemotherapy, progression-free survival increased by 34%. The median overall survival was 23 months in Keytruda plus chemotherapy combination versus 16.1 months in the chemotherapy alone. The median progression-free survival was 9.7 months versus 5.6 months in the chemotherapy alone.