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Enhertu reduced the risk of disease progression or death compared to chemotherapy in certain patients with metastatic breast cancer - News - PharmaTimes
Daiichi Sankyo UK, Limited: ENHERTU - (TRASTUZUMAB DERUXTECAN) NOW AVAILABLE VIA THE CANCER DRUGS FUND FOR THE TREATMENT OF HER2 POSITIVE METASTATIC BREAST CANCER Reimbursement decisions in Scotland, Wales, and Northern Ireland to be announced later this year Daiichi Sankyo UK, Limited (hereafter, Daiichi Sankyo) and AstraZeneca UK today welcome the news that the National Institute for Health and Care Excellence (NICE) has recommended 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. In the UK, almost 54,000 cases of breast cancer in women are diagnosed annually, with an estimated one in five cases being HER2 positive.
Press release content from Business Wire. The AP news staff was not involved in its creation. ENHERTU® ▼ (TRASTUZUMAB DERUXTECAN) NOW AVAILABLE VIA THE CANCER DRUGS FUND FOR THE TREATMENT OF HER2 POSITIVE METASTATIC BREAST CANCER April 20, 2021 GMT Daiichi Sankyo UK, Limited (hereafter, Daiichi Sankyo) and AstraZeneca UK today welcome the news that the National Institute for Health and Care Excellence (NICE) has recommended 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. In the UK, almost 54,000 cases of breast cancer in women are diagnosed annually, with an estimated one in five cases being HER2 positive. 1,2,3 The impact of the disease is significant, with breast cancer responsible for approximately 12,000 deaths per year. 1 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. 4
Enhertu accepted via cancer drugs fund for HER2-positive breast cancer 20th April 2021 The National Institute for Health and Care Excellence (NICE) has recommended AstraZeneca (AZ) and Daiichi Sankyo’s Enhertu for use within the cancer drugs fund (CDF) for the treatment of previously-treated HER2-positive metastatic breast cancer. NICE’s recommendation is based on results from the Phase II DESTINY-Breast01 trial of Enhertu in 184 patients with HER2-positive metastatic breast cancer who have received two or more prior anti-HER2-based therapies. Results demonstrated a confirmed objective response rate (ORR) of 61.4% with Enhertu treatment, including a 6.5% complete response rate and a 54.9% partial response rate.
UK conditionally approves new treatment for HER2 positive breast cancer 25 The UK has conditionally approved Enhertu ® (trastuzumab deruxtecan) as a monotherapy for the treatment of unresectable or metastatic HER2 positive breast cancer based on Phase II trial results. The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has granted conditional marketing authorisation to Enhertu ® (trastuzumab deruxtecan) as a monotherapy for the treatment of adult patients with unresectable or metastatic human epidermal growth factor receptor 2 (HER2) positive breast cancer who have received two or more prior anti-HER2 based regimens. The drug, developed by Daiichi Sankyo UK Ltd and AstraZeneca, was authorised based on results from the Phase II DESTINY-Breast01 trial of trastuzumab deruxtecan (5.4 mg/kg) in 184 patients with HER2 positive metastatic breast cancer. As of the data cut-off in June 2021, the drug demonstrated a confirmed objective response rate of 61.4 percent, including a 6.5 percent complete response rate and a 54.9 percent partial response rate.