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 perce
NICE recommends Revlimid for newly diagnosed multiple myeloma patients
27th January 2021
Bristol Myers Squibb’s (BMS) Revlimid (lenalidomide) has received a recommendation from the UK’s National Institute of Health and Care Excellence (NICE) for newly diagnosed multiple myeloma patients.
In its Final Appraisal Document (FAD), NICE recommended Revlimid as a maintenance treatment after autologous stem cell transplant (ASCT) for newly diagnosed multiple myeloma in adults.
In September 2020, NICE initially turned down NHS funding of Revlimid in this indication, after concluding that the cost-effectiveness estimates for the drug in this setting were uncertain.
According to BMS, around 1,150 eligible patients in England will have immediate access to Revlimid from today, with interim funding provided via the Cancer Drugs Fund (CDF).
Gilead’s Jyseleca is given a NICE recommendation for rheumatoid arthritis
JAK inhibitor approved for use in moderate-to-severe RA
Gilead Sciences’ rheumatoid arthritis (RA) treatment Jyseleca has been given a recommendation from the UK’s National Institute of Health and Care Excellence (NICE).
Jyseleca (filgotinib) is an oral JAK inhibitor that can be administered as a monotherapy or used alongside another another common RA medicine called methotrexate.
Patients with moderate-to-severe RA will now be able to access the drug on the NHS in England, if they have responded inadequately to previous intensive therapy with two or more disease-modifying anti-rheumatic drugs (DMARDs).
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