Accord S L U — Zolsketil pegylated liposomal EMA EPAR public assessment report (EMEA/H/C/005320, 2022)
Accord S L U · 2022 · EMA EPAR public assessment report
Report summary
Accord Healthcare S.L.U. sought EMA marketing authorization for Zolsketil pegylated liposomal, a hybrid doxorubicin hydrochloride product for metastatic breast cancer, ovarian cancer, multiple myeloma, and AIDS-related Kaposi's sarcoma. This formulation, distinct from non-liposomal Adriamycin, was compared to Caelyx for quality, non-clinical, and clinical comparability. Pharmaceutical development ensured a robust, stable product qualitatively and quantitatively equivalent to Caelyx, confirmed by extensive physicochemical and in vitro cytotoxicity studies. Non-clinical and clinical assessments, including a bioequivalence study in ovarian cancer patients, demonstrated comparable pharmacokinetics and safety profiles between Zolsketil and Caelyx for both encapsulated and unencapsulated doxorubicin. The study confirmed bioequivalence based on AUC and Cmax, with a comparable safety profile despite not being powered for safety comparisons.
Key findings — cited to the page
| Grade 2 AEs | 59 | · p.41 |
| Grade 1 AEs | 140 | · p.41 |
| Grade 3 AEs | 26 | · p.41 |
| Grade 5 AEs (death related to AE) | 6 | · p.41 |
| Approved indication | For treatment of advanced ovarian cancer in women who have failed a first-line platinum-based chemotherapy regimen. | Zolsketil pegylated liposomal · p.10 |
| Approved indication | In combination with Bortezomib for the treatment of progressive multiple myeloma in patients who have received at least one prior therapy and who have already undergone or are unsuitable for bone marrow transplant. | Zolsketil pegylated liposomal · p.10 |
| Procedure start date | 20 June 2019 | · p.8 |
| Approved indication | As monotherapy for patients with metastatic breast cancer, where there is an increased cardiac risk. | Zolsketil pegylated liposomal · p.10 |
| Comparator product authorization date | 21-06-1996 | Caelyx pegylated liposomal, 2 mg/ml, concentrate for solution for infusion · Union · p.8 |
| Pegylated liposomes average diameter | 100 nm | · p.11 |
| Standard Doxorubicin tissue distribution volume | 700 to 1,100 l/m2 | Standard Doxorubicin hydrochloride · p.11 |
| Pegylated liposomes half-life | 55 hours | humans · p.10 |
Source: Accord S L U ↗ · License: EMA - reuse permitted with acknowledgement. Summary and findings are extracted from the published document; every figure cites its page. Informational only — not investment advice. Explore the Oncology library →