Zolsketil pegylated liposomal

Zolsketil pegylated liposomal is approved for several indications. It is indicated as monotherapy for patients with metastatic breast cancer who have an increased cardiac risk. It is also approved for the treatment of advanced ovarian cancer in women who have failed a first-line platinum-based chemotherapy regimen. Additionally, Zolsketil pegylated liposomal is indicated 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. Finally, it is approved for the treatment of AIDS-related Kaposi's sarcoma (KS) in patients with low CD4 counts (< 200 CD4 lymphocytes/mm3) and extensive mucocutaneous or visceral disease.

Regulatory review for Zolsketil pegylated liposomal began on 20 June 2019, with a CHMP positive opinion issued on 24 March 2022. The reference product was authorized on 24-10-1979, and a comparator product on 21-06-1996.

In safety evaluations, 66 patients were dosed. A total of 231 adverse events (AEs) were reported by 40 patients. Of these, 140 were Grade 1 AEs, 59 were Grade 2 AEs, and 26 were Grade 3 AEs. There were 6 Grade 5 AEs (death related to AE). AEs with causality assessed as possible numbered 31, while 60 AEs were assessed as probable/likely, and 134 AEs were assessed as unlikely.