IMPORTANT SAFETY INFORMATION for SCEMBLIX® (asciminib) Tablets

 

Myelosuppression

  • Thrombocytopenia, neutropenia, and anemia, including grade 3/4 reactions, have occurred in patients receiving SCEMBLIX
  • Perform complete blood counts every 2 weeks for the first 3 months of treatment and monthly thereafter or as clinically indicated. Monitor patients for signs and symptoms of myelosuppression
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INDICATIONS

SCEMBLIX® (asciminib) tablets is indicated for the treatment of adult patients with:

  • Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in chronic phase (CP), previously treated with 2 or more tyrosine kinase inhibitors (TKIs)
    • This indication is approved under accelerated approval based on major molecular response (MMR). Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial
  • Ph+ CML in CP with the T315I mutation

Unmet Needs in CML

Unmet Needs in CML

Patients with CML who have resistance and/or intolerance to 2 or more TKIs may need a different approach1-6

Using line after line of ATP-competitive TKIs may lead to low response rates.2,7,8

In a Phase 1/2 study of 118 patients receiving bosutinib who had been previously treated with ≥2 TKIs9:

24% of patients achieved CCyR and 15% of patients achieved MMR with SCEMBLIX

24% of patients achieved CCyR and 15% of patients achieved MMR with SCEMBLIX

In a separate study of patients with CML-CP, CML-AP, and CML-BC who relapsed after successive TKIs:

  • New BCR-ABL1 mutations were found in 83% of patients treated with 2nd- or 3rd-line TKIs who had relapsed
  • T315I was the most common mutation among those patients, found in 36% of them

 

Patients with CML may experience intolerance in later lines1-6

Infographic showing up to 55% of CML patients in 3rd line were intolerant to a previous TKI

Infographic showing up to 55% of CML patients in 3rd line were intolerant to a previous TKI

Patient Types

CONSIDER A DIFFERENT Ph+ CML-CP TREATMENT FOR:

Patient Type 1: Patients who are resistant to ATP-competitive TKI therapy in the ≥2nd-line setting

Patient Type 2: Patients who have the T315I mutation

Patient Type 3: Patients who are intolerant to ATP-competitive TKI therapy in the ≥2nd-line setting

Patient Type 1: Patients who are resistant to ATP-competitive TKI therapy in the ≥2nd-line setting

Patient Type 2: Patients who have the T315I mutation

Patient Type 3: Patients who are intolerant to ATP-competitive TKI therapy in the ≥2nd-line setting

Not actual patients.

Until 2021, no treatments had demonstrated superior efficacy, such as response rates, vs a 2nd-generation TKI in a Phase 3 trial

Until 2021, no treatments had demonstrated superior efficacy, such as response rates, vs a 2nd-generation TKI in a Phase 3 trial

AP, accelerated phase; ATP, adenosine 5’-triphosphate; BC, blast crisis.

*Data based on a multicenter, open-label Phase 1/2 study of best cumulative response rates to bosutinib (starting dose: 500 mg/day) in patients previously treated with and who developed resistance to a 1st-line TKI. Additionally, these patients were resistant to or intolerant to a ≥2nd-line TKI. One patient in the study had CML-AP. The median follow-up was 28.5 months. In this study, CCyR was defined as 0% Ph+ metaphases, and MMR was defined as ≥3-log reduction from standardized baseline in ratio of BCR-ABL to ABL transcripts.
Data based on an analysis of mutations in patients treated with 2nd- or 3rd-line TKIs who had relapsed (n=54). BCR-ABL mutations were found in 83% (n=45/54) of patients who relapsed on previous TKIs, and those mutations are believed to be the cause of resistance development. Of those patients, the T315I mutation was found in 36% (n=16/45).

 

References: 1. Soverini S, Gnani A, Colarossi S, et al. Blood. 2009;114(10):2168-2171. 2. Garg RJ, Kantarjian H, O'Brien S, et al. Blood. 2009;114(20):4361-4368. 3. Ibrahim AR, Paliompeis C, Bua M, et al. Blood. 2010;116(25):5497-5500. 4. Gambacorti-Passerini C, Brümmendorf TH, Kim D-W, et al. Am J Hematol. 2014;89(7):732-742. 5. Shah NP, Kim D-W, Kantarjian H, et al. Haematologica. 2010;95(2):232-240. 6. Kantarjian HM, Giles FJ, Bhalla KN, et al. Blood. 2011;117(4):1141-1145. 7. Bosi GR, Fogliatto LM, Costa TEV, et al. Hematol Transfus Cell Ther. 2019;41(3):222-228. 8. Iacob RE, Zhang J, Gray NS, Engen JR. PLoS One. 2011;6(1):e15929. 9. Khoury JH, Cortes JE, Kantarjian HM, et al. Blood. 2012;119(15):3403-3411. 10. Giles FJ, Abruzzese E, Rosti G, et al. Leukemia. 2010;24(7):1299-1301. 11. Scemblix [prescribing information]. East Hanover, NJ: Novartis Pharmaceuticals Corp; 2021. 12. O’Brien SG, Guilhot F, Larson RA, et al. N Engl J Med. 2003;348(11):994-1004. 13. Saglio G, Kim D-W, Issaragrisil S, et al. N Engl J Med. 2010;362(24):2251-2259. 14. Kantarjian H, Shah NP, Hochhaus A, et al. N Engl J Med. 2010;362(24):2260-2270. 15. Cortes JE, Gambacorti-Passerini C, Deininger MW, et al. J Clin Oncol. 2018;36(3):231-237. 16. Cortes JE, Kantarjian HM, Brümmendorf TH, et al. Blood. 2011;118(17):4567-4576. 17. Shah NP, Kantarjian HM, Kim D-W, et al. J Clin Oncol. 2008;26(19):3204-3212. 

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*The National Comprehensive Cancer Network makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way.

References: 1. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Chronic Myeloid Leukemia V2.2022. © National Comprehensive Cancer Network, Inc. 2021. All rights reserved. Accessed November 19, 2021. To view the most recent and complete version of the guideline, go online to NCCN.org. NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way. 2. Scemblix [prescribing information]. East Hanover, NJ: Novartis Pharmaceuticals Corp; 2021.

INDICATIONS

SCEMBLIX® (asciminib) tablets is indicated for the treatment of adult patients with:

  • Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in chronic phase (CP), previously treated with 2 or more tyrosine kinase inhibitors (TKIs)
    • This indication is approved under accelerated approval based on major molecular response (MMR). Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial
  • Ph+ CML in CP with the T315I mutation

 

IMPORTANT SAFETY INFORMATION for SCEMBLIX® (asciminib) Tablets

Myelosuppression

  • Thrombocytopenia, neutropenia, and anemia, including grade 3/4 reactions, have occurred in patients receiving SCEMBLIX
  • Perform complete blood counts every 2 weeks for the first 3 months of treatment and monthly thereafter or as clinically indicated. Monitor patients for signs and symptoms of myelosuppression
  • Based on the severity of thrombocytopenia and/or neutropenia, reduce dose, temporarily withhold, or permanently discontinue SCEMBLIX as described in the prescribing information

Pancreatic Toxicity

  • Pancreatitis (including grade 3 reactions) and asymptomatic elevation in serum lipase and amylase (including grade 3/4 elevations), have occurred in patients receiving SCEMBLIX
  • Assess serum lipase and amylase levels monthly during treatment with SCEMBLIX, or as clinically indicated. Monitor patients for signs and symptoms of pancreatic toxicity. Perform more frequent monitoring in patients with a history of pancreatitis
  • If lipase and amylase elevation are accompanied by abdominal symptoms, temporarily withhold SCEMBLIX and consider appropriate diagnostic tests to exclude pancreatitis
  • Based on the severity of lipase and amylase elevation, reduce dose, temporarily withhold, or permanently discontinue SCEMBLIX as described in the prescribing information

Hypertension

  • Hypertension, including grade 3/4 reactions, have occurred in patients receiving SCEMBLIX
  • Monitor and manage hypertension using standard antihypertensive therapy during treatment with SCEMBLIX as clinically indicated
  • For grade 3 or higher reactions, temporarily withhold, reduce dose, or permanently discontinue SCEMBLIX as described in the prescribing information depending on persistence of hypertension

Hypersensitivity

  • Hypersensitivity, including grade 3/4 reactions, have occurred in patients receiving SCEMBLIX. Reactions included rash, edema, and bronchospasm
  • Monitor patients for signs and symptoms and initiate appropriate treatment as clinically indicated
  • For grade 3 or higher reactions, temporarily withhold, reduce dose, or permanently discontinue SCEMBLIX as described in the prescribing information depending on persistence of hypersensitivity

Cardiovascular Toxicity

  • Cardiovascular toxicity (including ischemic cardiac and central nervous system conditions; and arterial thrombotic and embolic conditions) and cardiac failure have occurred in patients receiving SCEMBLIX. Some toxicities were grade 3/4 and 3 fatalities were reported
  • Arrhythmia, including QTc prolongation, have occurred in patients receiving SCEMBLIX. Some of these arrhythmias were grade 3
  • Monitor patients with a history of cardiovascular risk factors for cardiovascular signs and symptoms. Initiate appropriate treatment as clinically indicated
  • For grade 3 or higher cardiovascular toxicity, temporarily withhold, reduce dose, or permanently discontinue SCEMBLIX as described in the prescribing information depending on persistence of cardiovascular toxicity

Embryo-Fetal Toxicity

  • SCEMBLIX can cause fetal harm. Advise females of reproductive potential of the potential risk to a fetus if SCEMBLIX is used during pregnancy or if the patient becomes pregnant while taking SCEMBLIX
  • Verify the pregnancy status of females of reproductive potential prior to starting treatment with SCEMBLIX. Advise females to use effective contraception during treatment and for at least 1 week after the last SCEMBLIX dose

ADVERSE REACTIONS

  • Most common adverse reactions (≥20%) were upper respiratory tract infections, musculoskeletal pain, fatigue, nausea, rash, and diarrhea
  • Most common laboratory abnormalities (≥20%) were platelet count decreased, triglycerides increased, neutrophil count decreased, hemoglobin decreased, creatine kinase increased, alanine aminotransferase increased, lipase increased, and amylase increased

DRUG INTERACTIONS

  • Asciminib is an inhibitor of CYP3A4, CYP2C9, and P-gp. Asciminib is a CYP3A4 substrate
  • Closely monitor for adverse reactions during concomitant use of strong CYP3A4 inhibitors and SCEMBLIX at 200 mg twice daily
  • Avoid concomitant use of itraconazole oral solution containing hydroxypropyl-β-cyclodextrin and SCEMBLIX at all recommended doses
  • Closely monitor for adverse reactions during concomitant use of certain CYP3A4 substrates and SCEMBLIX at 80 mg total daily dose. Avoid use of SCEMBLIX at 200 mg twice daily
  • Avoid concomitant use of CYP2C9 substrates and SCEMBLIX at all recommended doses. If coadministration with 80 mg total daily dose is unavoidable, reduce the CYP2C9 substrate dosage as recommended in its prescribing information. If coadministration with 200 mg twice daily is unavoidable, consider alternative therapy with a non-CYP2C9 substrate
  • Closely monitor for adverse reactions during concomitant use of certain P-gp substrates and SCEMBLIX at all recommended doses

Please see full Prescribing Information.