Evomela

EVOMELA Efficacy and Safety

EVOMELA—Efficacy and safety demonstrated in a
pivotal clinical study1,2

EVOMELA was evaluated for myeloablative conditioning in multiple myeloma patients undergoing autologous stem cell transplantation (ASCT) in a Phase IIb, multicenter, open-label, single-arm, nonrandomized US clinical study (n=61).1,2

Please see pivotal study design here.

Study confirmed the efficacy and acceptable safety profile of EVOMELA as a high-dose conditioning regimen for ASCT in patients with multiple myeloma.1,3,4

Contraindicated in patients with a history of serious allergic reaction to melphalan.
Please see the safety profile of EVOMELA here.

 

Proven efficacy

  • An overall response rate of 95% at follow-up (Day +90 to Day +100)1
EVOMELA EVOMELA

*Overall response rate is categorized as partial response or better.1
†Follow-up = Day +90 to Day +100.1

 

Myeloablation and engraftment achieved in all patients1

Evomela Evomela

‡Median time to myeloablation or engraftment.1
§Myeloablation was defined as any of the following: absolute neutrophil count (ANC) <500/ mm4, absolute lymphocyte count <100/mm4, or platelet count <20,000/mm4. Neutrophil engraftment was defined as ANC>500/mm4 x 3 consecutive daily assessments. Platelet engraftment was defined as untransfused platelet counts >20,000/mm4 x 3 consecutive daily assessments. Nonengraftment was defined as failure to reach an ANC>500/mm4 x 3 consecutive daily assessments by Day 90–100.1

Selected Important Safety Information

Warnings and Precautions

Hypersensitivity:
  • Acute hypersensitivity reactions, including anaphylaxis, have occurred in approximately 2% of patients who received an intravenous formulation of melphalan. Symptoms may include urticaria, pruritus, edema, and skin rashes and, in some patients, tachycardia, bronchospasm, dyspnea, and hypotension. Discontinue treatment with EVOMELA for serious hypersensitivity reactions.

 

EVOMELA—Safety profile

Evomela Evomela

Please see additional Common Adverse Reactions and Important Safety Information for palliative treatment here.

References

  1. EVOMELA [prescribing information]. Irvine, CA: Spectrum Pharmaceuticals; March 2016.
  2. Hari P, Aljitawi OS, Arce-Lara C, et al. A phase IIb, multicenter, open-label, safety, and efficacy study of high-dose, propylene glycol-free melphalan hydrochloride for injection (EVOMELA) for myeloablative conditioning in multiple myeloma patients undergoing autologous transplantation. Biol Blood Marrow Transplant. 2015;21(12):2100-2105.
  3. Melphalan Hydrochloride for Injection [prescribing information]. Mylan Institutional LLC; August 2012.
  4. Aljitawi OS, Ganguly S, Abhyankar SH, et al. Phase IIa cross-over study of propylene glycol-free melphalan (LGD-353) and alkeran in multiple myeloma autologous transplantation. Bone Marrow Transplant. 2014;49(8):1042-1045.

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