Melphalan is under clinical development by Spectrum Pharmaceuticals and currently in the Phase II in clinical pathway. The characteristics of the clinical trial as well as other attributes related to the drug, regulations, and company play a fundamental role in ensuring the likelihood of transition that the drug moves from its current development stage to next.

According to GlobalData, the latest event to affect Melphalan’s likelihood of approval (LoA) and phase transition for Primary Systemic Amyloidosis took place on 07 Jul 2022, which decreased the likelihood that the drug progresses to the next phase in its clinical pathway and decreased the likelihood of final approval for this indication.

GlobalData uses proprietary data and analytics to provide a complete picture of this assessment in their Melphalan Likelihood of Approval (LoA) and Phase Transition Success Rate (PTSR) Report.

Melphalan overview

Melphalan (Evomela) is a phenylpropanoic acid derivative, acts as antineoplastic agent. It is formulated as lyophilized powder for solution for intravenous route of administration. Evomela is indicated for use as a high-dose conditioning treatment prior to hematopoietic progenitor (stem) cell transplantation in patients with multiple myeloma, for the palliative treatment of patients with multiple myeloma for whom oral therapy is not appropriate.

Melphalan (Evomela) is under development for the treatment of light chain amyloidosis undergoing high dose therapy and autologous hematopoietic progenitor cell transplant, relapsed and refractory multiple myeloma and primary systemic amyloidosis.

Spectrum Pharmaceuticals overview

Spectrum Pharmaceuticals (Spectrum) is a biopharma company that acquires, develops, and commercializes novel drug candidates for treatment of cancer. The company’s pipeline products include ROLONTIS, for treatment of chemotherapy-induced neutropenia helps to reduce the frequency of multiplication of tumors. This product is in phase 3 trails.; Poziotinib, an irreversible tyrosine kinase inhibitor, for non-small cell lung cancer (NSCLC) tumors with various mutations. This product is in phase 2 trials and lead candidate for the organization. The company has R&D facilities in, Massachusetts and California, the US. The company operates in the US, Europe, Japan, and other countries. Spectrum is headquartered in Henderson, Nevada, the US.

Quick View Melphalan LOA Data

Report Segments
  • Innovator (Non-NME)
Drug Name
  • Melphalan
Administration Pathway
  • Intravenous
Therapeutic Areas
  • Metabolic Disorders
  • Oncology
Key Developers
Highest Development Stage
  • Marketed

GlobalData, the leading provider of industry intelligence, provided the underlying data, research, and analysis used to produce this article.

GlobalData’s Likelihood of Approval analytics tool dynamically assesses and predicts how likely a drug will move to the next stage in its clinical pathway (PTSR), as well as how likely the drug will be approved (LoA). This is based on a proprietary algorithm built from the drugs’ sales forecast, regulatory milestones, cost forecasts, WACC rate and other proprietary data sources found on GlobalData’s Pharmaceutical Intelligence Center.