FDA's Bad Ad Program Pays Off (yet again)

FDA’s Office of Prescription Drug Promotion blasts out another enforcement action on August 1, 2024

Company:? Mirati Therapeutics, a Bristol Myers Squibb [BMS] company

Product: KRAZATI? (adagrasib) tablets, for oral use

Material: Healthcare Professional (HCP) Website

Link to FDA Untitled Letter | Cited Material Link

Indication: KRAZATI is indicated for the treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic NSCLC, as determined by an FDA approved test, who have received at least one prior systemic therapy.

This indication is approved under accelerated approval based on objective response rate (ORR) and duration of response (DOR). Continued approval for this indication may be contingent upon verification and description of a clinical benefit in a confirmatory trial(s).

Executive Summary

The website makes false or misleading claims and representations about the benefits of Krazati.

FDA states, 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. 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.*

Misleading Efficacy Presentations

• FDA reminds Mirati/BMS 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
• Progression Free Survival (PFS) and Overall Survival(OS) are time-to-event efficacy endpoints. Time-to-event efficacy endpoints in single-arm trials are generally uninterpretable because it is not possible to determine if the observed effect (e.g., survival time) is attributable to the drug or the natural history of the disease.
• Krazati was approved based on an effect shown on Objective Response Rate (ORR) and Duration of Response (DOR) endpoints in KRYSTAL-1, a single-arm trial.

Key Takeaways

• The inclusion of qualifying statements and/or study limitations are not sufficient to mitigate the overall misleading impression created by the inclusion of misleading efficacy presentations.
• The website was submitted on FDA Form 2253, however, the letter credits the Bad Ad Program as well for helping bring this compliance situation to light. FDA's Bad Ad Program was initiated in 2010 and is still actively supporting enforcement actions. By reporting suspected false or misleading prescription drug promotion, HCPs can help ensure that the information they’re relying on is truthful and not misleading, contributing to the protection of patients and the public health.

FDA requested action

Mirati/BMS needs to submit a written response to the letter within 15 working days from the date of receipt…listing all promotional communications (with the 2253 submission date) for Krazati that contain representations like those described above, and explaining the plan for the timely discontinuation of such communications, or for ceasing distribution of Krazati.

About Constellation

Constellation is a NYC-based, women & minority owned, SaaS company founded in 2016. Our one-of-a-kind tech platform enables Life Sciences marketers to achieve scale and speed of content creation and deployment. Our rules-based system automatically generates compliant content at scale - enabling Life Sciences teams to localize and personalize content across the omnichannel ecosystem. Simply put, we help our clients do more with less.

Please do not hesitate to reach out to [email protected] if you have any questions about this enforcement letter and how it relates to the work we are doing for clients.

*American Cancer Society: Key Statistics for Lung Cancer. See: https://www.cancer.org/cancer/types/lungcancer/about/key-statistics.html.