By Karuna Jaggar, Executive Director

Just three months after premature approval by the Food and Drug Administration (FDA), new data released at the American Society of Clinical Oncology (ASCO) challenges the earlier hype surrounding Roche’s immunotherapy atezolizumab (or Tecentriq) to treat metastatic triple-negative breast cancer.

The March 2019 approval of atezolizumab was widely celebrated as a big step forward in treating advanced triple-negative breast cancer—despite the lack of evidence that it helps people live longer or improves their quality of life, and comes with a list price of $13,400 a month!

At the time, I explained Breast Cancer Action’s opposition to the approval and why the FDA shouldn’t use surrogate endpoints like Progression Free Survival for approvals.

Unfortunately, final results from the IMpassion130 study presented at ASCO last week showed no significant overall survival benefit of atezolizumab versus placebo–a huge let down to everyone who so desperately needs new effective treatment for their aggressive breast cancer. Although it’s worth noting that for a subgroup of patients with higher PD-L1 expression, there was a numerical difference of seven months (25 vs. 18 in the placebo group), it was also not statistically significant (with a hazard ratio of 0.71).

Expensive drugs that don’t work do more harm than good. The FDA’s approval should be reserved for safe and effective treatments that have been shown to improve overall survival or quality of life. Anything less is a give-away to Pharma and biotech at the expense of patients.