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A Bioequivalence Study Comparing Two Pomalidomide Hard Capsule Formulations in Healthy Chilean Subjects
Marcelo Gomes Davanço1, Thaís Pereira Vespasiano1, Jessé Moisan2
1Medical & Clinical Affairs Department, United Medical Ltd. (A Knight Therapeutics Company), Sao Paulo 04085-001, SP, Brazil.
Pharmaceuticals (Basel, Switzerland)
|July 28, 2026
Summary
This study confirms that Xetrane®, a new pomalidomide formulation, is bioequivalent and well-tolerated compared to Imnovid®. This supports regulatory approval for a new multiple myeloma treatment option.
Area of Science:
- Pharmacokinetics and Drug Bioequivalence
- Hematological Oncology
- Pharmaceutical Sciences
Background:
- Multiple myeloma (MM) is a prevalent hematological cancer with a relapsing-refractory course, necessitating novel therapeutic strategies.
- Pomalidomide is a key agent for refractory MM, often used in combination therapy.
- Evaluating generic drug formulations is crucial for expanding treatment accessibility.
Purpose of the Study:
- To assess the bioequivalence of a new pomalidomide hard capsule formulation (Xetrane®) against the reference product (Imnovid®).
- To evaluate the tolerability and safety profile of the test and reference pomalidomide formulations.
- To support regulatory submission for a branded generic pomalidomide product in Latin America.
Main Methods:
- An open-label, randomized, single-dose, crossover study in healthy male subjects.
- Administration of single oral doses of Xetrane® 4 mg and Imnovid® 4 mg with a 7-day washout period.
- Plasma pomalidomide concentrations analyzed via LC-MS/MS to determine pharmacokinetic parameters.
Main Results:
- Bioequivalence was demonstrated, with geometric mean ratios for Cmax (106.24%) and AUC0-t (94.67%) falling within regulatory acceptance criteria.
- Both Xetrane® and Imnovid® formulations were found to be well-tolerated by study participants.
- Pharmacokinetic analysis confirmed comparable absorption and disposition of pomalidomide from both formulations.
Conclusions:
- Xetrane® 4 mg hard capsule is bioequivalent to Imnovid® 4 mg hard capsule.
- The study supports the regulatory approval of Xetrane® as a safe and effective generic alternative for multiple myeloma treatment.
- This research contributes to increasing patient access to essential cancer therapies.
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