AstraZeneca/Daiichi Sankyo’s Enhertu recommended by NICE for advanced breast cancer
21 Dec 2022
Clinical ResultPhase 3
Preview
Source: PMLiVE
AstraZeneca and Daiichi Sankyo’s Enhertu (trastuzumab deruxtecan) has been recommended by the National Institute for Health and Care Excellence (NICE) for the treatment of HER2-positive unresectable or metastatic breast cancer after at least one anti-HER2 therapy.
The recommendation follows updated results from the DESTINY-Breast03 phase 3 trial, announced by the companies earlier this month, in which Enhertu demonstrated a statistically significant and clinically meaningful improvement in overall survival compared to standard of care trastuzumab emtansine in patients previously treated with trastuzumab and a taxane.
The observed survival benefit was consistent across analysed subgroups, including patients with or without baseline brain metastases, with or without baseline visceral disease, those who were HR-positive or HR-negative, and regardless of prior pertuzumab or lines of systemic therapy.
In its final draft guidance however, NICE noted that there is not enough evidence yet demonstrating how much longer patients live with Enhertu compared with trastuzumab emtansine because the trial is still ongoing.
As such, the cost-effectiveness estimates are 'highly uncertain' and Enhertu cannot be recommended for routine use in the NHS.
Enhertu has therefore been recommended for use within a managed access arrangement, meaning patients can have the treatment while more evidence about its effectiveness is generated. NICE will then use this data to recommend whether the medicine should be made routinely available on the NHS.
NHS England Cancer Drugs Fund clinical lead professor Peter Clark said: “This cutting-edge drug will give hundreds of patients with secondary incurable breast cancer hope, increasing the amount of time people have before their cancer gets worse, and allowing them to live normal, healthy lives for longer.”
Breast cancer is one of the leading causes of cancer-related deaths globally, with more than two million cases diagnosed in 2020, resulting in nearly 685,000 deaths worldwide. Approximately one in five patients with breast cancer are considered HER2-positive.
“The main goals of therapy for advanced breast cancer are to control the disease and improve survival, and it is therefore critical to continue to improve upon existing treatment options, particularly in the metastatic setting,” said Sara Hurvitz, medical oncologist, professor of medicine, and director of the breast cancer clinical trials programme in the division of haematology-oncology at the David Geffen School of Medicine at University of California, Los Angeles (UCLA), and medical director for the clinical research unit at the UCLA Jonsson Comprehensive Cancer Center, when the updated DESTINY-Breast03 results were announced.
For more details,please visit the original website
The content of the article does not represent any opinions of Synapse and its affiliated companies. If there is any copyright infringement or error, please contact us, and we will deal with it within 24 hours.
Organizations
Chat with Hiro
Hot reports
Get started for free today!
Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.
Start your data trial now!
Synapse data is also accessible to external entities via APIs or data packages. Empower better decisions with the latest in pharmaceutical intelligence.