Warren Kotler, a 61-year-old living with stage 4 metastatic breast cancer, has defied his initial prognosis of three to five years. Diagnosed eight years ago with a condition that affects only one per cent of men, Kotler has relied on a combination of drug treatments and radiation therapy to maintain an excellent quality of life. However, his access to potentially beneficial new drugs is being limited.
Access Denied: Capivasertib (Truqap)
This summer, Kotler's oncologist suggested capivasertib (Truqap), a drug approved in Canada in January 2024 for HR-positive, HER2-negative advanced breast cancer. Clinical studies indicate that capivasertib can delay cancer progression by blocking AKT, an enzyme crucial for cell growth. However, despite its potential benefits, Truqap is not covered by Ontario's Trillium Drug Program, and AstraZeneca denied compassionate coverage because Health Canada has only approved the drug for women.
Health Canada's Stance
Health Canada's regulatory decision summary cites the limited number of men (seven out of approximately 700 participants) in the Phase 3 clinical study. While the drug appeared to slow cancer progression in these men for about two months (compared to seven months for the entire study population), Health Canada expressed concerns about the drug's toxicity and side effects such as diarrhea, rash, and nausea.
Expert Opinions and Reimbursement Recommendations
Canada's Drug Agency, however, reached a different conclusion. Its expert review committee recommended that Truqap be reimbursed for all adult patients with conditions. The committee argued that the proportion of men in the study reflected the rate of breast cancer among men, and the small sample size made it impossible to definitively conclude that the drug would be less effective in male patients.
The Doctor's Perspective
Dr. Philippe Bedard, Kotler's oncologist at Toronto's Princess Margaret Cancer Centre, believes capivasertib could be an effective option for patients like Kotler. He notes the frustration of excluding men from clinical trials, especially given the similar disease biology in men and women.
Calls for Flexibility and Common Sense
Dr. Gerald Batist, director of the Segal Cancer Centre at Montreal's Jewish General Hospital, advocates for flexibility and scientific reasoning in such cases. He emphasizes that male breast cancers behave similarly to those in women and are treated accordingly. Batist urges regulatory bodies to consider approvals from other expert panels and agencies worldwide, balancing the need to minimize toxicity with the urgency of providing access to better drugs.
The Patient's Plea
For patients like Kotler, the issue is about having the option to make an informed choice. "I don't have a choice with Truqap. It's not available to me," he laments, underscoring the urgent need for continued treatment options to prolong his life and fulfill his responsibilities.
