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Celdoxome pegylated liposomal (doxorubicin hydrochloride)

Region

🇪🇺 EU

Active substance

doxorubicin hydrochloride

Company

Baxter Holding B.V.

Status

Lapsed

Therapeutic area

Breast Neoplasms; Ovarian Neoplasms; Multiple Myeloma; Sarcoma, Kaposi

CHMP opinion

Thu 21 Jul 2022

EU approval

Thu 15 Sep 2022

Application

EMEA/H/C/005330

ATC

L01DB01

Official record

www.ema.europa.eu

Indication

Celdoxome pegylated liposomal is indicated in adults: as monotherapy for patients with metastatic breast cancer, where there is an increased cardiac risk. or treatment of advanced ovarian cancer in women who have failed a first-line platinum-based chemotherapy regimen. 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 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).

Regulatory milestones

No milestones recorded in the last year.

Same substance in other markets

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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.