The FDA told Bristol Myers Squibb in an Aug. 1 letter that a website for its cancer drug Krazati had misleading claims around its efficacy.
In its letter, the agency said the promotional website gives dubious representations of Krazati’s effectiveness in patients with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC), for which the drug was approved in 2022.
In the letter to Bristol Myers, the FDA took issue with how the company presented data from the KRYSTAL-1 trial, one of the key pieces of research behind the drug’s marketing authorization.
The website promoting Krazati said that for the depth of response, 80% of patients experienced tumor shrinkage. Depth of response included patients who had stable disease, a partial response, or a complete response — but KRYSTAL-1 didn’t determine that the result was because of the drug’s efficacy, the FDA said.
The agency also wrote in its letter that “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.”
It also took issue with how Bristol Myers described the drug’s overall survival and median progression-free survival, saying that “these claims are misleading because they are based on the results of a trial that is not capable of producing interpretable OS and PFS results.”
In an emailed statement to Endpoints News, Bristol Myers said it would respond to the FDA.
“We take seriously the responsibility of ensuring the information we share with health care providers, patients and all other stakeholders is evidence-backed and meets all regulatory standards,” the company said.
Krazati, which BMS acquired with its takeover of Mirati Therapeutics, generated $32 million in second-quarter revenue.