UK first as breast cancer drug is approved for use in Scotland

On Monday, sacituzumab govitecan was approved by the Scottish Medicines Consortium for use in the health service for patients with triple negative cancer – a aggressive form of the disease which often affects younger women.

David Ferguson, of Cancer Research UK in Scotland, said it is “very welcome” to that the new treatment has been approved for use north of the border.

“People with this type of breast cancer have fewer treatment options than people with other types of the disease,” he said.

“This decision makes a new treatment available that could give them more precious time with their loved ones.”

The approval means that about 150 women in Scotland each year could be eligible for the treatment, one which drug maker Gilead Sciences said could extend their lives by several months and slow progression of the disease when compared to existing treatments.

Dr Caroline Michie, honorary clinical senior lecturer at the University of Edinburgh, hailed the approval of the drug, which is the first new medicine approval for use after first line treatment in over a decade.

“Patients with this form of the disease, unfortunately, are often younger, and, for them, having hope is everything,” she said.

“I know many patients of mine have been anxiously awaiting this decision and will be hugely relieved and delighted today.”

Triple negative breast cancer is associated with poorer survival outcomes compared to other types of the disease.

Black women are disproportionately affected by the disease, and are twice as likely to be diagnosed than white or Asian women, the drug maker said.

Once diagnosed, people will live on average about 13 months.

About 4,700 people are diagnosed with breast cancer in Scotland each year, with between 11 and 15% of these cases triple negative.

Mark MacGregor, chairman of the Scottish Medicines Consortium, said: “A diagnosis of triple negative breast cancer can be devastating for patients and their families, particularly as the prognosis is so poor.

“We hope that our decision to accept sacituzumab govitecan, will offer patients with this form of breast cancer the prospect of a better quality of life and valuable extra time with family and friends.”

Scotland is the first part of the UK to approve sacituzumab govitecan for use on the NHS, with decisions from other nations expected later this year.

The drug was just one of a raft of approvals made by the medicines consortium on Monday, paving the way for new drugs to be prescribed to people on the Scottish NHS.

Sotorasib was approved on an interim basis for patients with specific types of non-small cell lung cancer.

The first of its kind medicine targets a specific gene fault which doctors were previously unable to treat with drugs.

Lorlatinib has also been accepted when used on its own as a first line treatment or non-small cell lung cancer.

Dostarlimab has also been given the green light for use for those with advanced endometrial cancer where the disease has progressed despite treatment with platinum-based chemotherapy.

Endometrial cancer is a rare, life-limiting condition and the approval body said there are limited treatment options, and, as dostarlimab is a targeted treatment, it may be better tolerated than chemotherapy.

Berotralstat was also accepted for the routine prevention of frequent severe attacks of hereditary angioedema, a rare inherited condition, causing swelling that can affect any part of the body including the hands, feet, arms, legs, intestines, face and throat.

Two drugs which were up for approval were not accepted. Mr MacGregor said: “The committee was unable to accept solriamfetol (Sunosi) as the evidence provided by the company on the clinical and cost effectiveness of the treatment was not clear.”

“We were also unable to accept the new formulation of hydrocortisone as the evidence provided by the company on the benefits of using this medicine instead of the current treatment options was not strong enough to justify its cost.”