| | RATIFY: The largest phase 3 clinical trial conducted in AML* |
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| | | | | | | * | For the treatment of adult patients with newly diagnosed FLT3+ ITD and TKD acute myeloid leukemia (AML)1 | | |
| | | | | | • | RATIFY was a phase 3, randomized, double-blind, placebo-controlled, international study1,2 |
| | | | | RATIFY STUDY DESIGN1,2† | | | | | | | | | | | † | Transplantation was allowed but not specifically mandated per study protocol. Patients who proceeded to hematopoietic stem cell transplantation (SCT) stopped receiving study treatment, but all patients were followed for survival.1,2 |
| | | | ‡ | Patients in the pivotal study were not rerandomized at the start of postconsolidation treatment and, therefore, there is no assessment of the efficacy of RYDAPT® (midostaurin) capsules in this stage alone.1 |
| | | | | Efficacy and safety were evaluated through all phases of the study1,2 | | | | | | • | The primary end point in RATIFY was OS, which was measured from the date of randomization until death by any cause1 |
| | | | | IN THE RATIFY TRIAL, Patients with newly diagnosed FLT3+ AML DEMONSTRATED significant and sustained survival benefits on RYDAPT1 | | | | |  | | In the risk of death compared with standard chemotherapy plus placebo: HR=0.77
(95% CI, 0.629-0.953), P=.016 | |
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 | | In the risk of death compared with standard chemotherapy plus placebo: HR=0.77
(95% CI, 0.629-0.953), P=.016 | |
| | | | | | • | The most common adverse reactions (≥20%) were febrile neutropenia, nausea, mucositis, vomiting, headache, petechiae, musculoskeletal pain, epistaxis, device-related infection, hyperglycemia, and upper respiratory tract infection |
| | | | | | • | Most frequent grade 3/4 adverse reactions (≥10%) were febrile neutropenia, device-related infection, and mucositis |
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| Learn more about the RATIFY trial
and RYDAPT | |
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| | | INDICATION for RYDAPT® (midostaurin) capsules | | | Acute Myeloid Leukemia | | | RYDAPT is indicated, in combination with standard cytarabine and daunorubicin induction and cytarabine consolidation chemotherapy, for the treatment of adult patients with newly diagnosed acute myeloid leukemia (AML) who are FLT3 mutation–positive, as detected by an FDA-approved test. | | | | | Limitations of Use | | | RYDAPT is not indicated as a single-agent induction therapy for the treatment of patients with AML. | | | | | IMPORTANT SAFETY INFORMATION for RYDAPT® (midostaurin) capsules | | | CONTRAINDICATIONS | | | | • | Do not use in patients with hypersensitivity to midostaurin or its excipients. Hypersensitivity reactions have included anaphylactic shock, dyspnea, flushing, chest pain, and angioedema |
| | | | | WARNINGS AND PRECAUTIONS | | | Embryofetal Toxicity | | | | • | Do not use during pregnancy. Midostaurin caused severe embryofetal abnormalities and death in animal studies |
| | | | • | Verify pregnancy status of females of reproductive potential within 7 days prior to initiating RYDAPT |
| | | | • | Advise females of reproductive potential to use effective contraception during treatment and for at least 4 months after the last dose |
| | | | • | Males taking RYDAPT should use effective contraception with females of reproductive potential and pregnant women and for at least 4 months after the last dose |
| | | | • | Pregnancy exposure registry to monitor pregnancy outcomes: Females who may have been exposed to RYDAPT during pregnancy, directly or through a male partner receiving RYDAPT, should contact Novartis Pharmaceuticals Corporation at 1-888-669-6682 and/or at https://psi.novartis.com |
| | | | | Pulmonary Toxicity | | | | • | Cases of interstitial lung disease and pneumonitis, some fatal, have occurred in patients treated with RYDAPT as monotherapy or with chemotherapy |
| | | | • | Monitor patients for pulmonary symptoms. Discontinue RYDAPT in patients who experience signs or symptoms of interstitial lung disease or pneumonitis without an infectious etiology |
| | | | | ADDITIONAL CONSIDERATIONS | | | Lactation | | | | • | Because of the potential for serious adverse reactions in breastfed infants from RYDAPT, advise women not to breastfeed during treatment with RYDAPT and for at least 4 months after the last dose |
| | | | | Infertility | | | | • | Based on findings in animals, RYDAPT may impair fertility in females and males of reproductive potential. It is unknown whether these effects on fertility are reversible |
| | | | | Drug Interactions | | | | • | Strong CYP3A4 Inducers: Avoid concomitant use as strong CYP3A4 inducers decrease exposure to midostaurin and may reduce efficacy |
| | | | • | Strong CYP3A4 Inhibitors: Coadministration with strong CYP3A4 inhibitors may increase midostaurin concentrations and may increase the risk of toxicity. Monitor patients for increased risk of adverse reactions, especially during the first week of RYDAPT use in each chemotherapy cycle and the first week of consecutive RYDAPT administration. Consider alternative therapies that do not strongly inhibit CYP3A4 activity |
| | | | | ADVERSE REACTIONS | | | Acute Myeloid Leukemia | | | | • | Most common adverse reactions (≥20%) were febrile neutropenia (83%), nausea (83%), mucositis (66%), vomiting (61%), headache (46%), petechiae (36%), musculoskeletal pain (33%), epistaxis (28%), device-related infection (24%), hyperglycemia (20%), and upper respiratory tract infection (20%) |
| | | | • | Most frequent grade 3/4 adverse reactions (≥10%) were febrile neutropenia (84%), device-related infection (16%), and mucositis (11%) |
| | | | • | Most common (≥10%) lab abnormalities were alanine aminotransferase increase (71%), hypernatremia (21%), and hypocalcemia (74%) |
| | | | | Please see full Prescribing Information for RYDAPT® (midostaurin) capsules. | | | | | bid, twice daily; CR, complete remission; FLT3, FMS-like tyrosine kinase 3; HR, hazard ratio; ITD, internal tandem duplication; OS, overall survival; TKD, tyrosine kinase domain. | | | | | References: 1. Rydapt [prescribing information]. East Hanover, NJ: Novartis Pharmaceuticals Corp; 2018. 2. Data on file. Study no. CPKC412A2301. Novartis Pharmaceuticals Corp; 2016. | | | | | This is a sponsored message from DMD on behalf of Novartis Pharmaceuticals Corporation. DMD provides sponsored health care–related messages from trusted third parties. This material is intended specifically and exclusively for US health care professionals. You are receiving this email because you have subscribed and agreed to receive information from the DMD email list. | | | | | If you prefer not to receive further messages from DMD, please click here and confirm your request. | | | | | DMD | | | 10255 W. Higgins Road, Suite 280
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| | | Novartis Pharmaceuticals Corporation | | | | © 2019 Novartis | 6/19 | MID-1215457 |
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| | | Novartis Pharmaceuticals Corporation | | | | © 2019 Novartis | 6/19 | MID-1215457 |
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