Men get breast cancer, too. But they can't always access new drugs

Warren Kotler has outlived his prognosis. 

Eight years ago, Kotler was told he had three to five years to live. The diagnosis: Stage 4 metastatic breast cancer. It's a common illness among women, but a rare one among men, who account for only one per cent of cases.

Kotler, 61, has received a mix of drug treatments and several courses of radiation therapy. His quality of life is excellent, he said: he got married two years ago. He travels often. He regularly goes on long bike rides. 

Despite that, the Toronto man knows the cancer could eventually outsmart his treatments. The plan he and his medical team developed: "Stick around long enough. There's new drugs that are going to be coming on, and hopefully those will be of benefit," Kotler said.

This summer, his oncologist suggested a new drug: capivasertib, sold as Truqap.

Clinical studies suggest the drug, which was approved in Canada in January 2024, could hold off the cancer from progressing for several months for patients with a type of advanced breast cancer known as HR positive, HER2-negative. These cancers respond to hormone-therapy drugs and do not have abnormal levels of the protein HER2, which can accelerate tumour growth. The drug stops the cancer from growing by blocking AKT – one of the enzymes needed for cell growth. 

But Truqap is expensive. Canada's Drug Agency says it costs around $10,000 for a 28-day supply. And while Kotler is able to get provincial help for some of his other pricey drugs through Ontario's Trillium Drug Program, Truqap is not covered by the program. 

Kotler's medical team has asked the drug manufacturer to cover the cost of the drug on a compassionate basis through a patient support program it runs. AstraZeneca said it cannot. 

The reason? Health Canada has only approved the drug for women. 

Some other jurisdictions — the United States and the European Union — have approved the use of the drug for both men and women following a clinical trial. 

When CBC News asked Health Canada about the decision, the department pointed to its regulatory decision summary for the drug, which says too few men were involved in the Phase 3 clinical study: seven out of around 700 participants.

For those men, the drug appeared to stop the cancer from getting worse for about two months — compared to around seven months for the entire study population. Health Canada raised concerns over the toxicity of the drug, including side effects like diarrhea, rash and nausea.

While side effects are a part of many treatments, there is a weighing of risk and benefit — and whether medications used at the end stages of cancer meaningfully improve survival and quality of life. A group of cancer doctors in North America say medications with marginal benefits are being overused for patients who are nearing the end of their lives. They say ultimately whether a patient decides if a drug is worth taking is a deeply personal choice, and one that should come after an honest conversation about the reality of what a drug can do.

But Canada's Drug Agency, an independent non-profit organization that provides objective evidence to healthcare decision-makers, came to a different conclusion than Health Canada in the case of Truqap.