Skip to main content

See the Impact of CAMZYOS Over Time in SRT-Eligible Symptomatic Adult Patients1-3

Explore this page:    |    SRT Eligibility    |    LVOT Gradient    |    NYHA Class

Fewer Patients Remained Guideline-Eligible or Decided to Proceed with SRT on CAMZYOS at Week 161,3

Primary Composite Functional Endpoint1,2: Proportion of patients who remained guideline-eligible (based on symptoms, NYHA class, and LVOT gradient criteria) for SRT*† or decided to proceed with SRT

  • At Week 16, 18% (n=10/56) of patients in the CAMZYOS group remained guideline-eligible or decided to proceed with SRT, vs 77% (n=43/56) of patients in the placebo group (Difference (95% CI): 59% (44, 74); P<0.0001)1,3
  • 2 patients in the CAMZYOS group and 2 patients in the placebo group decided to proceed with SRT1

>3x as many patients avoided SRT‡ with CAMZYOS vs placebo at Week 16, with results evaluated at ~2.5 years1-3

‡No longer guideline-eligible and did not choose to undergo SRT by Week 16.3

The prespecified endpoints in VALOR-LTE were not powered for significance, and statistical comparisons have not been made.

VALOR-HCM (Week 16)
  • After Week 16, patients were offered the opportunity to continue in the LTE, with crossover for the patients in the placebo group to receive CAMZYOS 5 mg once daily3,4
  • Two patients in each group decided to proceed with SRT by the end of VALOR-HCM1,3
VALOR-LTE (Week 128)
  • 14% (8/56) of patients in the CAMZYOS group and 17% (n=9/52) in the CAMZYOS crossover group remained guideline-eligible or decided to proceed with SRT2
  • 3 patients in the CAMZYOS group and 4 patients in the CAMZYOS crossover group decided to proceed with SRT2

*SRT is an invasive procedure requiring specialized care. SRT is recommended for patients with intractable, persistent symptoms despite maximal medical therapy.5
†SRT guideline eligibility was based on symptoms, NYHA class, and LVOT gradients in the 2011 ACC/AHA HCM guideline criteria. Patients were categorized as either NYHA Class II oHCM with exertional syncope or near syncope or NYHA Class III or IV despite background therapy, and having a dynamic LVOT gradient at rest or with provocation ≥50 mmHg.3,6
§Includes placebo-to-CAMZYOS crossover patients.
ACC=American College of Cardiology; AHA=American Heart Association; CI=confidence interval; HCM=hypertrophic cardiomyopathy; LTE=long-term extension; LVOT=left ventricular outflow tract; NYHA=New York Heart Association; oHCM=obstructive hypertrophic cardiomyopathy; SRT=septal reduction therapy.

Reducing LVOT Obstruction Is an Objective Measure of Response in Obstructive HCM1,5,7

VALOR-HCM Secondary Endpoint: Mean change (SD) in postexercise LVOT peak gradient from baseline to Week 16: 
-39 (37) mmHg mean change vs placebo (-2 [29] mmHg); Difference (95% CI): -38 (-49, -28); P<0.00011

VALOR-LTE Exploratory Endpoint: Reductions in Valsalva LVOT gradient were maintained through ~2.5 years2

-59.4 mmHg total change from baseline in Valsalva LVOT peak gradient2

(95% CI: -66.0, -52.7) for the total group who received CAMZYOS (n=108)

The prespecified endpoints were not powered for significance, and statistical comparisons have not been made.

VALOR-HCM (Week 16)
  • The mean change from baseline in Valsalva LVOT peak gradient was -45.2 mmHg in patients on CAMZYOS (n=56) vs 0.4 mmHg in patients 
on placebo (n=56); Difference (95% CI): -47.6 mmHg (-58.2, -37.0)3
VALOR-LTE (Week 128)
  • The total change from baseline in Valsalva LVOT peak gradient was -59.4 mmHg (95% CI: -66.0 to -52.7) for the total population who received CAMZYOS (n=108)2
  • Valsalva LVOT gradient reduced by -53.1 mmHg (95% CI: -61.8, -44.4) in the original CAMZYOS group, and -66.5 mmHg (-76.7, -56.4) in the placebo-to-CAMZYOS group from Week 16 to 1282

CI=confidence interval; HCM=hypertrophic cardiomyopathy; LVOT=left ventricular outflow tract; SD=standard deviation.

NYHA Class Is a Subjective Measure of a Patient's Symptoms1,8

Secondary Endpoint: ≥1 NYHA class improvement from baseline to Week 16:
63% of patients on CAMZYOS (n=56) improved by ≥1 NYHA class vs 21% of patients on placebo (n=56); Difference (95% CI): 41% (25, 58); P<0.00012

Exploratory Endpoint: CAMZYOS improved symptoms by ≥1 NYHA class in patients from baseline through ~2.5 years2

VALOR-HCM (Week 16)
  • -27% (n=15/56) of patients on CAMZYOS improved by ≥2 NYHA classes vs 2% (n=1/56) of patients on placebo3

Exploratory endpoint was not powered for significance, and statistical comparisons have not been made.

VALOR-LTE (Week 128)
  • 91% of the evaluable population (n=87/96) achieved ≥1 NYHA class improvement2
  • In the original CAMZYOS group, 86% had ≥1 NYHA class improvement, as did 75% of the placebo-to-CAMZYOS group2
  • 56.5% of patients on CAMZYOS were NYHA Class I (asymptomatic)2

CI=confidence interval; NYHA=New York Heart Association.

References:

  1. CAMZYOS [package insert]. Princeton, NJ: Bristol-Myers Squibb Company; 2026.
  2. Desai MY, Wolski K, Owens A, et al. Mavacamten in patients with hypertrophic cardiomyopathy referred for septal reduction: Week 128 results from VALOR-HCM. Circulation. 2025;151(19):1378-1390.
  3. Desai MY, Owens A, Geske JB, et al. Myosin inhibition in patients with obstructive hypertrophic cardiomyopathy referred for septal reduction therapy. J Am Coll Cardiol. 2022;80(2):95-108.
  4. Desai MY, Wolski K, Owens A, et al. Mavacamten in patients with hypertrophic cardiomyopathy referred for septal reduction: Week 128 results from VALOR-HCM. Circulation. 2025;151(19):1378-1390 [supplementary appendix].
  5. Ommen SR, Ho CY, Asif IM, et al. 2024 AHA/ACC/AMSSM/HRS/PACES/SCMR Guideline for the Management of Hypertrophic Cardiomyopathy: A Report of the American Heart Association/American College of Cardiology Joint Committee on Clinical Practice Guidelines. Circulation. 2024;149(23):e1239-e1311.
  6. Gersh BJ, Maron BJ, Bonow RO, et al. 2011 ACCF/AHA guideline for the diagnosis and treatment of hypertrophic cardiomyopathy: a report of the American College of Cardiology Foundation/American Heart Association task force on practice guidelines. Circulation. 2011;124:e783-e831.
  7. Olivotto I, Oręziak A, Barriales-Villa R, et al. Mavacamten for treatment of symptomatic obstructive hypertrophic cardiomyopathy (EXPLORER-HCM): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet. 2020;396(10253):759-769.
  8. Ho CY, Olivotto I, Jacoby D, et al. Study design and rationale of EXPLORER-HCM: evaluation of mavacamten in adults with symptomatic obstructive hypertrophic cardiomyopathy. Circ Heart Fail. 2020;13(6):e006853.
References

IMPORTANT SAFETY INFORMATION

WARNING: RISK OF HEART FAILURE

CAMZYOS reduces left ventricular ejection fraction (LVEF) and can cause heart failure due to systolic dysfunction.

Echocardiogram assessments of LVEF are required prior to and during treatment with CAMZYOS. Initiation of CAMZYOS in patients with LVEF <55% is not recommended. Interrupt CAMZYOS if LVEF is <50% at any visit or if the patient experiences heart failure symptoms or worsening clinical status.

Concomitant use of CAMZYOS with certain cytochrome P450 inhibitors or discontinuation of certain cytochrome P450 inducers may increase the risk of heart failure due to systolic dysfunction; therefore, the use of CAMZYOS is contraindicated with the following:

 
  • Strong CYP2C19 inhibitors
  • Moderate to strong CYP2C19 inducers or moderate to strong CYP3A4 inducers

Because of the risk of heart failure due to systolic dysfunction, CAMZYOS is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the CAMZYOS REMS Program.

CONTRAINDICATIONS

CAMZYOS is contraindicated with concomitant use of:

 
  • Strong CYP2C19 inhibitors
  • Moderate to strong CYP2C19 inducers or moderate to strong CYP3A4 inducers

WARNINGS AND PRECAUTIONS

Heart Failure
CAMZYOS reduces systolic contraction and can cause heart failure or significantly reduce ventricular function. Patients who experience a serious intercurrent illness (eg, serious infection) or arrhythmia (eg, atrial fibrillation or other uncontrolled tachyarrhythmia) are at greater risk of developing systolic dysfunction and heart failure.

Assess the patient’s clinical status and LVEF prior to and regularly during treatment and adjust the CAMZYOS dose accordingly. New or worsening arrhythmia, dyspnea, chest pain, fatigue, palpitations, leg edema, or elevations in N-terminal pro-B-type natriuretic peptide (NT-proBNP) may be signs and symptoms of heart failure and should also prompt an evaluation of cardiac function.

Asymptomatic LVEF reduction, intercurrent illnesses, and arrhythmias require additional dosing considerations.

Initiation of CAMZYOS in patients with LVEF <55% is not recommended. Avoid concomitant use of CAMZYOS in patients on disopyramide, ranolazine, verapamil with a beta blocker, or diltiazem with a beta blocker as these medications and combinations increase the risk of left ventricular systolic dysfunction and heart failure symptoms and clinical experience is limited.

CYP450 Drug Interactions Leading to Heart Failure or Loss of Effectiveness

CAMZYOS is primarily metabolized by CYP2C19 and CYP3A4 enzymes. Concomitant use of CAMZYOS and drugs that interact with these enzymes may lead to life-threatening drug interactions such as heart failure or loss of effectiveness.

Advise patients of the potential for drug interactions, including with over-the-counter medications (such as omeprazole, esomeprazole, or cimetidine). Advise patients to inform their healthcare provider of all concomitant products prior to and during CAMZYOS treatment.

CAMZYOS Risk Evaluation and Mitigation Strategy (REMS) Program

CAMZYOS is only available through a restricted program called the CAMZYOS REMS Program because of the risk of heart failure due to systolic dysfunction. Notable requirements of the CAMZYOS REMS Program include the following:

 
  • Prescribers must be certified by enrolling in the REMS Program
  • Patients must enroll in the REMS Program and comply with ongoing monitoring requirements
  • Pharmacies must be certified by enrolling in the REMS Program and must only dispense to patients who are authorized to receive CAMZYOS
  • Wholesalers and distributors must only distribute to certified pharmacies

Further information is available at  www.CAMZYOSREMS.com  or by telephone at  1-833-628-7367.

Embryo-Fetal Toxicity

CAMZYOS may cause fetal toxicity when administered to a pregnant female, based on animal studies. Confirm absence of pregnancy in females of reproductive potential prior to treatment and advise patients to use effective contraception during treatment with CAMZYOS and for 4 months after the last dose. Combined hormonal contraceptives (CHCs) containing a combination of ethinyl estradiol and norethindrone may be used with CAMZYOS. However, CAMZYOS may reduce the effectiveness of certain other CHCs. If these CHCs are used, advise patients to add nonhormonal contraception (such as condoms) during concomitant use and for 4 months after the last dose of CAMZYOS.

ADVERSE REACTIONS

In the EXPLORER-HCM trial, adverse reactions occurring in >5% of patients and more commonly in the CAMZYOS group than in the placebo group were dizziness (27% vs 18%) and syncope (6% vs 2%). There were no new adverse reactions identified in VALOR-HCM. The safety of CAMZYOS in pediatric patients (≥35 kg) was evaluated in SCOUT-HCM. There were no new adverse reactions compared to those identified in adult studies.

Effects on Systolic Function

In the EXPLORER-HCM trial, mean (SD) resting LVEF was 74% (6) at baseline in both treatment groups. Mean (SD) absolute change from baseline in LVEF was -4% (8) in the CAMZYOS group and 0% (7) in the placebo group over the 30-week treatment period. At Week 38, following an 8-week interruption of trial drug, mean LVEF was similar to baseline for both treatment groups. In the EXPLORER-HCM trial, 7 (6%) patients in the CAMZYOS group and 2 (2%) patients in the placebo group experienced reversible reductions in LVEF <50% (median 48%: range 35-49%) while on treatment. In all 7 patients treated with CAMZYOS, LVEF recovered following interruption of CAMZYOS.

DRUG INTERACTIONS

Potential for Other Drugs to Affect Plasma Concentrations of CAMZYOS

CAMZYOS is primarily metabolized by CYP2C19 and to a lesser extent by CYP3A4 and CYP2C9. Inducers and inhibitors of CYP2C19 and moderate to strong inhibitors or inducers of CYP3A4 may affect the exposures of CAMZYOS.

Impact of Other Drugs on CAMZYOS:

 
  • Strong CYP2C19 Inhibitors: Concomitant use increases CAMZYOS exposure, which may increase the risk of heart failure due to systolic dysfunction. Concomitant use is contraindicated
  • Moderate to Strong CYP2C19 Inducers or Moderate to Strong CYP3A4 Inducers:  Concomitant use decreases CAMZYOS exposure, which may reduce CAMZYOS’ efficacy. The risk of heart failure due to systolic dysfunction may increase with discontinuation of these inducers as the levels of induced enzyme normalizes. Concomitant use is contraindicated
  • Weak CYP2C19 Inhibitors or Moderate CYP3A4 Inhibitors: Concomitant use with a weak CYP2C19 inhibitor or a moderate CYP3A4 inhibitor increases CAMZYOS exposure, which may increase the risk of adverse drug reactions. Initiate CAMZYOS at the recommended starting dosage in patients who are on stable therapy with a weak CYP2C19 inhibitor or a moderate CYP3A4 inhibitor. Reduce dose of CAMZYOS by one level (ie, 15 mg to 10 mg, 10 mg to 5 mg, 5 mg to 2.5 mg, or 2.5 mg to 1 mg [pediatric dosing]) in patients who are on CAMZYOS treatment and intend to initiate a weak CYP2C19 inhibitor or a moderate CYP3A4 inhibitor. Avoid initiation of concomitant weak CYP2C19 and moderate CYP3A4 inhibitors in patients who are on the lowest recommended dose of CAMZYOS. For short-term use (eg, 1 week), interrupt CAMZYOS for the duration of treatment with a weak inhibitor of CYP2C19 or a moderate inhibitor of CYP3A4. CAMZYOS may be reinitiated at the previous dose immediately on discontinuation of concomitant therapy.
  • Moderate CYP2C19 Inhibitors or Strong CYP3A4 Inhibitors: Concomitant use with a moderate CYP2C19 inhibitor or strong CYP3A4 inhibitor increases CAMZYOS exposure, which may increase the risk of adverse drug reactions. Discontinuing use of a moderate CYP2C19 inhibitor or strong CYP3A4 inhibitor after long-term concomitant use may decrease CAMZYOS exposure, which may reduce CAMZYOS’ efficacy. Initiate CAMZYOS at one dose level below the recommended starting dose in patients who are on stable therapy with a moderate CYP2C19 inhibitor or a strong CYP3A4 inhibitor. Reduce dose of CAMZYOS by one level (ie, 15 mg to 10 mg; 10 mg to 5 mg; 5 mg to 2.5 mg; or 2.5 mg to 1 mg [pediatric dosing]) in patients who are on CAMZYOS and intend to initiate a moderate CYP2C19 inhibitor or a strong CYP3A4 inhibitor. Avoid initiation of concomitant moderate CYP2C19 and strong CYP3A4 inhibitors in patients who are on the lowest recommended dose of CAMZYOS. An increase in dose of CAMZYOS may be needed if the moderate inhibitor of CYP2C19 or strong inhibitor of CYP3A4 is discontinued after long-term concomitant use. Monitor for new or worsening symptoms. For short-term use (eg, 1 week), interrupt CAMZYOS for the duration of treatment with a moderate inhibitor of CYP2C19 or a strong inhibitor of CYP3A4. CAMZYOS may be reinitiated at the previous dose immediately on discontinuation of concomitant therapy.

Potential for CAMZYOS to Affect Plasma Concentrations of Other Drugs

CAMZYOS is an inducer of CYP3A4, CYP2C9, and CYP2C19. Concomitant use with CYP3A4, CYP2C9, or CYP2C19 substrates may reduce plasma concentration of these drugs. Closely monitor when CAMZYOS is used with concomitant CYP3A4, CYP2C9, or CYP2C19 substrates unless otherwise recommended in the Prescribing Information.

Certain Combined Hormonal Contraceptives (CHCs): Progestin and ethinyl estradiol are CYP3A4 substrates. Concomitant use of CAMZYOS may decrease exposures of certain progestins, which may lead to contraceptive failure. CHCs containing a combination of ethinyl estradiol and norethindrone may be used with CAMZYOS, but if other CHCs are used, advise patients to add nonhormonal contraception (such as condoms) or use an alternative contraceptive method that is not affected by CYP450 enzyme induction (eg, intrauterine system) during concomitant use and for 4 months after the last dose of CAMZYOS.

Drugs That Reduce Cardiac Contractility

Expect additive negative inotropic effects of CAMZYOS and other drugs that reduce cardiac contractility. Avoid concomitant use of CAMZYOS in patients on disopyramide, ranolazine, verapamil with a beta blocker, or diltiazem with a beta blocker as these medications and combinations increase the risk of left ventricular systolic dysfunction and heart failure symptoms and clinical experience is limited.

If concomitant therapy with a negative inotrope is initiated, or if the dose of a negative inotrope is increased, monitor LVEF closely until stable doses and clinical response have been achieved.

SPECIFIC POPULATIONS

Pregnancy

CAMZYOS may cause fetal harm when administered to a pregnant female. Advise pregnant females about the potential risk to the fetus with maternal exposure to CAMZYOS during pregnancy. There is a pregnancy safety study for CAMZYOS. If CAMZYOS is administered during pregnancy, or if a patient becomes pregnant while receiving CAMZYOS or within 4 months after the last dose of CAMZYOS, healthcare providers should report CAMZYOS exposure by contacting Bristol Myers Squibb at 1-800-721-5072 or www.bms.com.

Lactation

The presence of CAMZYOS in human or animal milk, the drug’s effects on the breastfed infant, or the effects on milk production are unknown. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for CAMZYOS and any potential adverse effects on the breastfed child from CAMZYOS or from the underlying maternal condition.

Females and Males of Reproductive Potential

Confirm absence of pregnancy in females of reproductive potential prior to initiation of CAMZYOS. Advise females of reproductive potential to use effective contraception during treatment with CAMZYOS and for 4 months after the last dose. CHCs containing a combination of ethinyl estradiol and norethindrone may be used with CAMZYOS. However, CAMZYOS may reduce the effectiveness of certain other CHCs. If these CHCs are used, advise patients to add nonhormonal contraception (such as condoms) or use an alternative contraceptive method during concomitant use and for 4 months after the last dose of CAMZYOS.

INDICATION

CAMZYOS® (mavacamten) is indicated for the treatment of adults and pediatric patients weighing 30 kg or more with symptomatic obstructive hypertrophic cardiomyopathy (HCM) to improve functional capacity and symptoms.

Please see U.S. Full Prescribing Information, including  Boxed WARNING.

Bristol Myers SquibbTM Logo

Legal Notice     Privacy Policy     Your Privacy Choices

© 2026 MyoKardia, Inc., a Bristol Myers Squibb company. 
CAMZYOS® and the CAMZYOS and MyCAMZYOS Logos are trademarks of MyoKardia, Inc.


3500-US-2600359   10/26

This site is intended for U.S. Healthcare Professionals only.