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.
Too few men in study, says Health Canada
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.
In a reimbursement review for Truqap, its expert review committee said the drug should be reimbursed for all adult patients — with conditions. The proportion of men in the study, it said, reflects the rate of breast cancer among men, and because there were so few men involved in the study, it was impossible to say for sure the drug would be less effective in male patients.
For Kotler, who is no stranger to the side effects of cancer drugs, it’s about having the option.
“In terms of quality of life, absolutely, I want to make an informed choice,” he said.
“I don’t have a choice with Truqap. It’s not available to me.”
More than 250 Canadian men are diagnosed with breast cancer each year, but they represent less than one per cent of diagnoses and are often not included in clinical trials for new drugs. Now, patients and doctors are calling on Health Canada to update its approval process.
‘It makes no sense’ says cancer doctor
Dr. Philippe Bedard, Kotler’s oncologist at Toronto’s Princess Margaret Cancer Centre, thinks the drug could be an effective option for some patients like Kotler.
“It’s very frustrating,” he said.
“Historically, men have been excluded from these types of clinical trials that test new drugs. And what we’ve learned is that the disease biology is really similar in men and women.”
Breast cancer is a rare illness among male patients.The Canadian Cancer Society estimates 290 men will be diagnosed with the disease this year and 60 will die, compared to some 28,000 women diagnosed and 5,500 who die from breast cancer each year in Canada.
Because of how rare the disease is among men, it could take much longer to gather the same amount of data for male patients as for women. In the case of Ibrance, another drug used to treat hormone receptor-positive, HER2-negative breast cancer, Health Canada expanded the drug approval for men three years after the drug was approved for women — after examining data based on the real-world use of the drug among male patients.
Dr. Gerald Batist, the director of the Segal Cancer Centre at Montreal’s Jewish General Hospital, says in situations like these, regulatory bodies need to use “some common sense and scientific reasoning.”
“It’s a very unusual cancer in men. But they do behave very much like breast cancers in women. We treat them very much like breast cancers in women. So it makes no sense,” he said.
In this case, Batist thinks flexibility is warranted, even as Health Canada balances risk and benefit.
“There’s a lack of data, but I think we have to recognize there’s a little bit of a limitation because of the numbers of the incidence in this. We have to look around the world and see other expert panels, regulatory agencies that have approved this drug,” he said.
“They don’t want to expose anyone to undue toxicity. On the other hand, we’re at a point where we want more access to better drugs that will help people, and that’s very urgent.”
An urgency patients like Kotler know well.
“I need to continue. I have a lot to do. I have a big list. I have three kids,” he said.