Bristol Myers Squibb gets positive CHMP opinion recommending nod for CAMZYOS for treatment of Symptomatic Obstructive Hypertrophic Cardiomyopathy

The positive opinion is based upon efficacy and safety results from two Phase 3 trials, EXPLORER-HCM and VALOR-HCM. Results from the Phase 3 EXPLORER-HCM trial, which evaluated CAMZYOS in patients with symptomatic obstructive HCM versus placebo, met all primary and secondary endpoints with statistical significance. EXPLORER-HCM showed CAMZYOS demonstrated a clear treatment effect, with clinically meaningful improvements in exercise capacity and symptoms, and functional status, as well as clinically meaningful improvement in left ventricular outflow tract obstruction. Results from the Phase 3 VALOR-HCM study evaluated CAMZYOS in patients with symptomatic obstructive HCM who met the 2011 ACC/AHA or 2014 ESC guideline criteria for septal reduction therapy (SRT) and who were referred for an invasive procedure. VALOR-HCM met statistical significance across all primary and secondary endpoints showing a valuable improvement across key cardiac measures which resulted in a clinically meaningful reduction in need or eligibility for SRT among CAMZYOS-treated patients versus placebo.

On April 28, 2022, the U.S. Food and Drug Administration (FDA) approved CAMZYOS for the treatment of adults with symptomatic NYHA class II-III obstructive HCM to improve functional capacity and symptoms. 

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