The prescribing information for Camzyos® (mavacamten) has been updated to include data related to its use in adults with symptomatic obstructive hypertrophic cardiomyopathy (HCM) who are eligible for septal reduction therapy (SRT).
Camzyos is an oral, selective allosteric inhibitor of cardiac myosin. It is indicated for adults with symptomatic New York Heart Association (NYHA) class II-III obstructive hypertrophic cardiomyopathy to improve functional capacity and symptoms. The updated labeling was based on data from the phase 3 VALOR-HCM trial (ClinicalTrials.gov Identifier: NCT04349072), which evaluated the effects of mavacamten in 112 patients with symptomatic obstructive HCM (NYHA class III-IV) who met the guideline criteria for SRT and had been referred for an invasive procedure. Patients were randomly assigned 1:1 to receive either mavacamten (2.5mg, 5mg, 10mg, or 15mg) or placebo for 16 weeks.
The primary endpoint was the composite of patients who decided to proceed with SRT prior to or at week 16 or who were eligible for SRT (left ventricular outflow tract [LVOT] gradient of ≥50 mmHg and NYHA class III-IV, or class II with exertional syncope or near syncope) at week 16.
Results showed mavacamten was superior to placebo in reducing the proportion of patients who met the primary endpoint (18% vs. 77%, respectively; P <.0001). Change from baseline to week 16 in secondary endpoints with mavacamten vs placebo were:
- Mean post-exercise LVOT gradient: -39 mmHg vs -2 mmHg (difference, -38 mmHg; 95% CI, -49, -28; P <.0001).
- Proportion with NYHA class improvement of at least 1 class: 63% vs 21% (difference, 41%; 95% CI, 25-58; P <.0001).
- Mean Kansas City Cardiomyopathy Questionaire-23 (KCCQ-23) Clinical Summary Score (CSS): +10 points vs +2 points (difference, 9 points; 95% CI, 5-14; P <.0001).
- Mean change in baseline in KCCQ-23 Total Symptom Score: +10 vs +2.
- Mean change in baseline in KCCQ-23 Physical Limitations: +10 vs +2.
“In order to provide broader access to treatment for those patients whose obstructive HCM becomes so advanced that guidelines recommend SRT, more treatment options are needed,” said Anjali T. Owens, MD, Medical Director of the Center for Inherited Cardiac Disease, Associate Professor of Medicine at the Perelman School of Medicine at the University of Pennsylvania, and VALOR-HCM trial investigator and executive committee member. “The VALOR-HCM study supports Camzyos as an oral treatment for obstructive HCM patients who are recommended for SRT.”
This article originally appeared on MPR
- US Food and Drug Administration approves addition of positive data from phase 3 VALOR-HCM study to Camzyos® (mavacamten) label. News release. Bristol Myers Squibb. June 15, 2023. Accessed June 20, 2023. https://www.businesswire.com/news/home/20230615624893/en/U.S.-Food-and-Drug-Administration-Approves-Addition-of-Positive-Data-from-Phase-3-VALOR-HCM-Study-to-CAMZYOS%C2%AE-mavacamten-Label.
- Package insert. Bristol Myers Squibb; 2023. Accessed June 20, 2023. https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/214998s001lbl.pdf.