Mirati gets OPDP untitled letter for misrepresenting cancer drug efficacy

The US Food and Drug Administration’s (FDA) Office of Prescription Drug Promotion (OPDP) has sent an untitled letter to Mirati Therapeutics for misleading the public about the efficacy of its cancer drug Krazati (adagrasib) on its website. The agency said the drugmaker makes claims about outcomes from a clinical trial of the drug, even though the trial was not intended to measure such outcomes.

In an untitled letter dated 1 August, FDA told Mirati, a Bristol Myers Squibb company, that it needs to stop overstating the efficacy of Krazati, which is approved to treat patients with certain kinds of lung cancer. The drug was approved by the agency under its accelerated approval pathway based on results from the KRYSTAL-1 multicenter, single-arm, open-label expansion cohort study that evaluated Objective Response Rate (ORR) and Duration of Response (DOR) as its clinical endpoints.

FDA said it had received several complaints through the FDA Bad Ad Program about how the drug was marketed on the company’s website at www.krazatihcp.com/n/efficacy.

“The website makes false or misleading claims and representations about the benefits of Krazati,” said FDA. “These violations are particularly concerning because the promotional communication makes misleading representations about the efficacy of Krazati in patients with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC).”

“Metastatic NSCLC is an incurable condition with a 5-year survival rate of less than 10%, and lung cancer is a serious public health concern and treatment for this condition involves serious risks,” the agency added. “Lung cancer is by far the leading cause of cancer death in the United States, accounting for about 1 in 5 of all cancer deaths.”

FDA noted that on the Krazati website, the company makes claims such as the disease control rate (DCR) in patients taking the drug is 80% and tumors shrank in 80% of Krazati patients in the KRYSTAL-1 clinical trial. However, the agency said the information is misleading because it uses composite data of stable disease (SD), partial response (PR), or complete response (CR) in patients who have taken the drug, even though the trial was not designed to evaluate the depth of response.

"It is misleading to include in promotional materials representations or suggestions that rely on a study or studies whose design is not capable of supporting such representations or suggestions," said FDA. "Since KRYSTAL-1 was a single-arm trial, it is not known whether the data on SD are attributable to treatment with Krazati."

"Consequently, the DCR calculations, which are based on a composite that includes SD data, and the associated 'depth of response' claim, are not supported by the data cited," the agency added. "Your presentation of these data conveys to viewers of the website that the data are relevant to their understanding of the efficacy of Krazati notwithstanding the limitations in the study."

Mirati was given 15 working days to respond to the untitled letter and either dispute FDA’s assertion that it is violating its advertising and promotional requirements or explain steps it is taking to rectify the issue.

Untitled Letter

Mirati gets OPDP untitled letter for misrepresenting cancer drug efficacy

Related topics

Recommended content

Welcome to the new RAPS Digital Experience