FDA approves ENHERTU® for treatment of adult patients with unresectable or metastatic Her2 positive breast cancer.
On December 30th, 2019
Daiichi Sankyo and AstraZeneca announced that the US Food and Drug Administration (FDA) approved ENHERTU® (fam-trastuzumab deruxtecan-nxki) for the treatment of adult patients with unresectable or metastatic HER2 positive breast cancer who have received two or more prior anti-HER2-based regimens in the metastatic setting. This indication is approved under accelerated approval based on tumor response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.
This FDA Accelerated Approval is based on the results of the single-arm, pivotal Phase II DESTINY-Breast01 trial of ENHERTU (5.4 mg/kg) monotherapy in patients with HER2-positive metastatic breast cancer. Trial results showed a confirmed objective response rate (ORR) of 60.3% (n=111; 95% CI: 52.9-67.4), including a 4.3% complete response rate (n=8) and a 56.0% partial response rate (n=103). As of August 1, 2019, the demonstrated median duration of response was 14.8 months (95% CI: 13.8-16.9) and median progression-free survival was 16.4 months (95% CI: 12.7-NE) based upon median duration of follow-up of 11.1 months. Patients enrolled in DESTINY-Breast01 received a median of five prior regimens (range: 2-17) for locally advanced/metastatic disease, including ado-trastuzumab emtansine (100%), trastuzumab (100%), and pertuzumab (66%).
The most common adverse events (frequency ≥20%, any grade) included nausea, fatigue, vomiting, alopecia, constipation, decreased appetite, anemia, neutropenia, diarrhea, leukopenia, cough and thrombocytopenia.
ENHERTU is approved with a Boxed WARNING for Interstitial Lung Disease (ILD)/pneumonitis and Embryo-Fetal Toxicity. Please see Important Safety Information below and visit www.ENHERTU.com<http://www.ENHERTU.com> for full Prescribing Information<http://www.enhertupi.com/>, including Boxed WARNING, and Medication Guide<https://dsi.com/prescribing-information-portlet/getPIContent?productName=Enhertu_Med&inline=true>.
Having this new treatment option addresses a continued unmet medical need for this patient population and further allows the treatment team to individualize patient care. As news of this approval begins to travel please reach out to me should any questions or requests for more information arise. You can view the full press release here<https://www.astrazeneca-us.com/content/az-us/media/press-releases/2019/enhertu-fam-trastuzumab-deruxtecan-nxki-approved-in-the-us-for-her2-positive-unresectable-or-metastatic-breast-cancer-following-two-or-more-prior-anti-her2-based-regimens-12202019.html>.
Important Safety Information
Indication
ENHERTU is a HER2-directed antibody and topoisomerase inhibitor conjugate indicated for the treatment of adult patients with unresectable or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2-based regimens in the metastatic setting.
This indication is approved under accelerated approval based on tumor response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.
Please see full Prescribing Information, including Boxed WARNING, and Medication Guide. Follow along with @AstraZenecaUS<https://twitter.com/AstraZenecaUS> on Twitter and AstraZeneca US Community Connections<https://www.facebook.com/AstraZenecaUSCommunityConnections/> on Facebook for news and highlights all year-round.
For more information, please visit ENHERTUhcp.com<https://www.enhertuhcp.com/>
Daiichi Sankyo and AstraZeneca announced that the US Food and Drug Administration (FDA) approved ENHERTU® (fam-trastuzumab deruxtecan-nxki) for the treatment of adult patients with unresectable or metastatic HER2 positive breast cancer who have received two or more prior anti-HER2-based regimens in the metastatic setting. This indication is approved under accelerated approval based on tumor response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.
This FDA Accelerated Approval is based on the results of the single-arm, pivotal Phase II DESTINY-Breast01 trial of ENHERTU (5.4 mg/kg) monotherapy in patients with HER2-positive metastatic breast cancer. Trial results showed a confirmed objective response rate (ORR) of 60.3% (n=111; 95% CI: 52.9-67.4), including a 4.3% complete response rate (n=8) and a 56.0% partial response rate (n=103). As of August 1, 2019, the demonstrated median duration of response was 14.8 months (95% CI: 13.8-16.9) and median progression-free survival was 16.4 months (95% CI: 12.7-NE) based upon median duration of follow-up of 11.1 months. Patients enrolled in DESTINY-Breast01 received a median of five prior regimens (range: 2-17) for locally advanced/metastatic disease, including ado-trastuzumab emtansine (100%), trastuzumab (100%), and pertuzumab (66%).
The most common adverse events (frequency ≥20%, any grade) included nausea, fatigue, vomiting, alopecia, constipation, decreased appetite, anemia, neutropenia, diarrhea, leukopenia, cough and thrombocytopenia.
ENHERTU is approved with a Boxed WARNING for Interstitial Lung Disease (ILD)/pneumonitis and Embryo-Fetal Toxicity. Please see Important Safety Information below and visit www.ENHERTU.com<http://www.ENHERTU.com> for full Prescribing Information<http://www.enhertupi.com/>, including Boxed WARNING, and Medication Guide<https://dsi.com/prescribing-information-portlet/getPIContent?productName=Enhertu_Med&inline=true>.
Having this new treatment option addresses a continued unmet medical need for this patient population and further allows the treatment team to individualize patient care. As news of this approval begins to travel please reach out to me should any questions or requests for more information arise. You can view the full press release here<https://www.astrazeneca-us.com/content/az-us/media/press-releases/2019/enhertu-fam-trastuzumab-deruxtecan-nxki-approved-in-the-us-for-her2-positive-unresectable-or-metastatic-breast-cancer-following-two-or-more-prior-anti-her2-based-regimens-12202019.html>.
Important Safety Information
Indication
ENHERTU is a HER2-directed antibody and topoisomerase inhibitor conjugate indicated for the treatment of adult patients with unresectable or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2-based regimens in the metastatic setting.
This indication is approved under accelerated approval based on tumor response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.
Please see full Prescribing Information, including Boxed WARNING, and Medication Guide. Follow along with @AstraZenecaUS<https://twitter.com/AstraZenecaUS> on Twitter and AstraZeneca US Community Connections<https://www.facebook.com/AstraZenecaUSCommunityConnections/> on Facebook for news and highlights all year-round.
For more information, please visit ENHERTUhcp.com<https://www.enhertuhcp.com/>
No comments have been posted yet.