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Seagen’s Tukysa granted NICE recommendation for breast cancer patients

Approximately 400 patients are expected to benefit from the treatment in England and Wales annually

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Seagen UK has announced that the National Institute for Health and Care Excellence (NICE) has issued a final appraisal determination, recommending Tukysa (tucatinib) as a combination treatment for patients with HER2-positive unresectable locally advanced or metastatic breast cancer after two, or more prior anti-HER2 treatments.

The combination treatment includes Tukysa combined with an intravenous infusion of trastuzumab and capecitabine and is now available for routine funding on the NHS in England and Wales, with around 400 patients set to benefit from the treatment annually. Meanwhile, those in Northern Ireland are expected to gain access in the coming weeks, once the final guidance is published.

NICE’s decision follows the Scottish Medicines Consortium (SMC) acceptance of tucatinib combination treatment, for use in NHS Scotland on 17 January.

The regulator based its decision on a pivotal HER2CLIMB trial – a randomised, global, double-blind, placebo-controlled study – which found that Tukysa, in combination with trastuzumab and capecitabine, reduced the risk of death by 34% and of disease progression or death by 46%. This was compared with trastuzumab and capecitabine alone. The study showed that overall survival was prolonged by 4.5 months compared to the control.

In patients diagnosed with brain metastases, the treatment combination significantly reduced disease progression and risk of death by 52%, extending overall survival by six months.

For these patients, the Tukysa combination provides them with access to a more tolerable drug which has the potential to reduce and/or delay the need for surgery or radiotherapy in HER2-positive patients whose cancer has progressed to the brain.

The trial is a first for advanced HER2-positive patients as it included patients with both controlled and uncontrolled brain metastases – who are typically excluded from clinical trials because of the severity of their condition.

Dr Alicia Okines, consultant medical oncologist at The Royal Marsden NHS Foundation Trust and team leader for the Breast Cancer Systemic Therapy Trials team at the Institute of Cancer Research, London said “[the] approval means that there is a new targeted treatment combination for women living with HER2 positive secondary breast cancer whose cancers have worsened, despite standard treatment with other targeted therapies. This is absolutely wonderful news as the drug combination can help control the cancer for longer and extend lives, including for patients with brain metastases”.

Peter Martin, country medical director, UK & Ireland at Seagen, added the “positive decision from NICE, making the tucatinib combination available for baseline NHS commissioning, is a real step-change for HER2-positive metastatic breast cancer patients”.

Article by
Fleur Jeffries

25th February 2022

From: Regulatory



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