Men also get breast cancer. But they do not always have access to new drugs

Warren Kotler outlived his prediction.

Eight years ago, Kotler was told he had three to five years to live. The diagnosis: stage four metastatic breast cancer. The disease is common in women, but rare in men: they make up only one percent of cases.

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

Still, the Toronto man knows that the cancer could eventually outsmart his treatments. The plan he and his team of doctors have developed: “Hang on long enough. There will be new drugs, and hopefully they will be of use,” Kotler said.

This summer, his oncologist suggested a new drug: capivasertib, sold under the name Truqap.

Clinical trials suggest the drug, approved in Canada in January 2024, could delay cancer progression for several months in patients with a type of advanced breast cancer called HR-positive, HER2-negative. These cancers respond to hormone therapy drugs and do not have abnormal levels of the protein HER2, which can speed tumor growth. The drug stops cancer growth by blocking AKT – one of the enzymes required for cell growth.

But Truqap is expensive. Canada's drug regulator says a 28-day supply costs around $10,000. And while Kotler can get assistance for some of his other expensive drugs through Ontario's Trillium Drug Program, Truqap is not covered by that program.

Kotler's medical team has asked the drugmaker to cover the cost of the drug on a compassionate basis through a patient assistance program it runs. AstraZeneca said this was not possible.

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

Health Canada: Too few men participate in study

Some other countries – the United States and the European Union – have approved the use of the drug for both men and women after clinical trials.

When CBC News asked Health Canada about the decision, the ministry referred to its Summary of the regulatory decision for the drug, which says that too few men are taking part in Phase 3 clinical trial: seven out of around 700 participants.

In these men, the drug appeared to prevent cancer from getting worse for about two months – compared to about seven months in the overall study population. Health Canada raised concerns about the drug's toxicity, including side effects such as diarrhea, rash and nausea.

Although many treatments have side effects, risks and benefits must be weighed – and it must be clarified whether drugs used in the final stages of cancer actually improve survival and quality of life. Group of cancer doctors in North America say that drugs with little benefit are being overused in patients nearing the end of their lives. They say that a patient's decision about whether a drug is worth taking is ultimately a deeply personal one, and that this decision should be made after an honest conversation about a drug's true effects.

But the Canadian Medicines Agency, an independent nonprofit organization that provides objective evidence to health care decision makers, came to a different conclusion than Health Canada in the Truqap case.

In a Reimbursement review For Truqap, the expert panel said the drug should be reimbursed for all adult patients – under certain conditions. The proportion of men in the study reflects the rate of breast cancer in men, and because so few men took part in the study, it cannot be said with certainty whether the drug is less effective in male patients.

For Kotler, who is familiar with the side effects of cancer drugs, it's about having an option.

“When it comes to quality of life, I definitely want to make an informed decision,” he said.

“With Truqap I have no choice. It is not available to me.”

WATCH HERE | Male breast cancer patients face problems accessing medication:

For some male patients, access to new breast cancer treatments is a challenge

More than 250 Canadian men are diagnosed with breast cancer each year. But that represents less than one percent of diagnoses and is often excluded from clinical trials for new drugs. Now patients and doctors are calling on Health Canada to revise its approval process.

“It doesn’t make sense,” says cancer doctor

Dr. Philippe Bedard, Kotler's oncologist at the Princess Margaret Cancer Centre in Toronto, believes the drug could be an effective option for some patients like Kotler.

“It’s very frustrating,” he said.

“Until now, men have been excluded from such clinical trials to test new drugs. We have now discovered that the disease biology is very similar in men and women.”

Breast cancer is a rare disease in male patients. The Canadian Cancer Society estimates that 290 men will be diagnosed with the disease this year and 60 will die from it. By comparison, in Canada, about 28,000 women are diagnosed with the disease and 5,500 die from breast cancer each year.

Because the disease is so rare in men, it could take much longer to collect 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 said expanded drug approval for men three years after The drug was approved for women – after studying data on the actual use of the drug in male patients.

Dr. Gerald Batist, director of the Segal Cancer Centre at the Jewish General Hospital in Montreal, says that in situations like these, regulators need to use “a little common sense and scientific reasoning.”

“It's a very uncommon cancer in men. But they behave very similarly to breast cancer in women. We treat them very similarly to breast cancer in women. So it doesn't make sense,” he said.

In this case, Batist believes flexibility is appropriate, even as Health Canada weighs the risks and benefits.

“There is a lack of data, but I think we have to recognize that there is some limitation because of the number of cases. We have to look around the world and look at other expert panels and regulators that have approved this drug,” he said.

“You don't want to expose anyone to unnecessary toxicity. On the other hand, we're at a point where we want better access to better medicines that help people, and that's urgently needed.”

An urgency that patients like Kotler know well.

“I have to keep going. I have a lot to do. I have a long list. I have three children,” he said.