FDA Updates Label for CAMZYOS®, Simplifying Monitoring and Expanding Patient Access

Bristol Myers Squibb announced that the U.S. Food and Drug Administration has updated the prescribing information for CAMZYOS® (mavacamten), easing treatment requirements for patients with symptomatic obstructive hypertrophic cardiomyopathy (oHCM).

Key changes include reducing required echocardiography monitoring from every 12 weeks to every 6 months for eligible patients in the maintenance phase, and relaxing certain contraindications related to drug interactions. Specifically, moderate CYP2C19 inhibitors and strong CYP3A4 inhibitors are now reclassified as drug interactions, broadening patient eligibility.

These updates are supported by long-term clinical trial data and real-world evidence, reflecting the strong safety profile of CAMZYOS. The therapy remains subject to a Risk Evaluation and Mitigation Strategy (REMS) due to risks of heart failure related to reduced systolic function.

With more than 15,000 patients treated in the U.S., CAMZYOS continues to be recognized as a standard-of-care therapy in clinical guidelines for oHCM. Bristol Myers Squibb emphasized that the changes will enhance both the patient and physician experience while maintaining careful safety oversight.