Enhertu now available via Cancer Drugs Fund following NICE decision
pharmafile | April 20, 2021 | News story | Manufacturing and Production | AstraZeneca, breast cancer, oncology
AstraZeneca and Daiichi Sankyo have announced that NICE has approved Enhertu (trastuzumab deruxtecan) for use within the Cancer Drugs Fund (CDF) as an option for treating HER2 positive unresectable or metastatic breast cancer in adults who have received two or more prior anti-HER2 based therapies.
This recommendation from NICE is based on the results of the Phase II DESTINY-Breast01 trial of trastuzumab deruxtecan in 184 patients with HER2 positive metastatic breast cancer. Results from the trial demonstrated a confirmed objective response rate of 61.4%, including a 6.5% complete response rate and a 54.9% partial response rate.
Haran Maheson, Commercial Director for Oncology at Daiichi Sankyo UK, said: “We are very proud to have worked with NICE, NHS England and the breast cancer community to make trastuzumab deruxtecan available, through the Cancer Drugs Fund, to eligible patients in England with HER2 positive metastatic breast cancer whose disease has progressed following treatment with two anti-HER2 directed therapies.”
In the UK roughly 54,000 cases of breast cancer in women are diagnosed annually, with an estimated one in five cases being HER2 positive. There are an estimated 35,000 people living with metastatic breast cancer in the UK, and in around 5% of women the breast cancer has already spread by the time it is diagnosed.
Professor Peter Schmid, of the Barts Cancer Institute, said: “HER2 positive disease impacts one in five women with breast cancer, yet there is still no clear standard of care for patients with HER2 positive disease who have progressed following first-and second-line therapy.
“The availability of trastuzumab deruxtecan through NHS England’s Cancer Drugs Fund is good news for patients and brings an important new treatment option to those whose disease has continued to progress despite previous treatment”.
Daiichi Sankyo and AstraZeneca will continue to work alongside NICE as additional data are collected throughout the managed access period. During this time, eligible patients will be able to access trastuzumab deruxtecan in advance of a decision from NICE on routine funding on the NHS.
Arun Krishna, Head of Oncology at AstraZeneca UK, said: “Though many treatment advances have been made in HER2 positive metastatic breast cancer, there has been no clear standard of care for patients following progression after second line treatment and many patients do not have a durable response to other available later-line options. To know that patients in England now have access to a new treatment option is welcome news indeed.”
The Cancer Drugs Fund recommendation will only be available for patients in England. Discussions with Welsh and Northern Irish health authorities are ongoing and the submission for the appraisal of trastuzumab deruxtecan to the Scottish Medicines Consortium is currently in development, with a decision expected later in the year.
Despite trastuzumab deruxtecan showing a generally tolerable safety profile in trials, there were significant adverse reactions reported. The most common being: nausea (79.9%), fatigue (60.3%), vomiting (48.7%), alopecia (46.2%), anaemia (33.8%), neutropenia (32.5%), thrombocytopenia (23.1%), and leukopenia (20.5%).
Cases of interstitial lung disease or pneumonitis were also reported in 15% of the 234 patients in the trial.
Kat Jenkins
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