dm+d

20479711000001103

New Medicines

Celdoxome pegylated liposomalBreast cancer, and other Caelyx indications

Information

Celdoxome pegylated liposomal
New formulation
YES Pharmaceutical Development Services
YES Pharmaceutical Development Services

Development and Regulatory status

None
Recommended for approval (Positive opinion)
None
2022
Jul 22Recommended for EU approval by CHMP for use in adults “as monotherapy for: patients with metastatic breast cancer, where there is an increased cardiac risk; treatment of advanced ovarian cancer in women who have failed a first-line platinum-based chemotherapy regimen; use 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; for treatment of AIDS-related Kaposi’s sarcoma (KS) in patients with low CD4 counts (< 200 CD4 lymphocytes/mm3) and extensive mucocutaneous or visceral disease.” Celdoxome pegylated liposomal will be available as a 2 mg/ml concentrate for dispersion for infusion [1].
Jul 22Celdoxome pegylated liposomal may be used as first-line systemic chemotherapy, or as second line chemotherapy in AIDS-KS patients with disease that has progressed with, or in patients intolerant to, prior combination systemic chemotherapy comprising at least two of the following agents: a vinca alkaloid, bleomycin and standard doxorubicin (or other anthracycline) [1].

Category

A pegylated liposomal formulation of adriamycin
In 2017, there were 46,109 new diagnoses of breast cancer in England, and 10,219 deaths from breast cancer [2].
Breast cancer, and other Caelyx indications
Intravenous infusion