Table 7.
Approval of systemic treatments for cutaneous T-cell lymphomas in the United States, Europe and Brazil, according to the package insert registered at the local regulatory agencies (FDA, EMA and ANVISA), respectively.
| Treatment | Class of medication | United States of America (FDA) | Europe (EMA) | Brazil (ANVISA) |
|---|---|---|---|---|
| Isotretinoin | Retinoid | Available. | Available. | Available. |
| Approved, but does not have a package insert indication for CTCL. | Approved, but does not have a package insert indication for CTCL. | Approved, but does not have a package insert indication for CTCL. | ||
| Acitretin | Retinoid | Available. | Available. | Available. |
| Approved, but does not have a package insert indication for CTCL. | Approved, but does not have a package insert indication for CTCL. | Approved, but does not have a package insert indication for CTCL. | ||
| Bexarotene | Retinoid | Available. | Available. | Not available. |
| Approved for cutaneous manifestations of CTCL in patients refractory to at least one previous systemic therapy. | Approved for cutaneous manifestations of CTCL in patients refractory to at least one previous systemic therapy. | Not approved. | ||
| Alpha-interferon | Immunomodulator | Available. | Available. | Available. |
| Approved, but does not have a package insert indication for CTCL. | Approved, but does not have a package insert indication for CTCL. | Approved, but does not have a package insert indication for CTCL. | ||
| Pegylated liposomal doxorubicin | Anthracycline chemotherapeutic drug | Available. | Available. | Available. |
| Approved, but does not have a package insert indication for CTCL. | Approved, but does not have a package insert indication for CTCL. | Approved, but does not have a package insert indication for CTCL. | ||
| Gemcitabine | Pyrimidine antagonist chemotherapeutic drug | Available. | Available. | Available. |
| Approved, but does not have a package insert indication for CTCL. | Approved, but does not have a package insert indication for CTCL. | Approved, but does not have a package insert indication for CTCL. | ||
| Chlorambucil | Alkylating chemotherapeutic drug | Available. | Not available. | Available. |
| Approved, but does not have a package insert indication for CTCL. | Not approved. | Approved for non-Hodgkin's lymphomas. | ||
| Methotrexate | Antimetabolite | Available. | Available. | Available. |
| Approved for advanced MF. | Approved, but does not have a package insert indication for CTCL. | Approved for non-Hodgkin's lymphomas. | ||
| Pralatrexate | Antimetabolite | Available. | Not available. | Not available. |
| Approved for recurrent or refractory peripheral T-cell lymphomas. | Not approved. | Not approved. | ||
| Romidepsin | HDAC inhibitor | Available. | Not available. | Not available. |
| Approved for patients with CTCL who received at least one previous systemic therapy. | Not approved. | Not approved. | ||
| Vorinostat | HDAC inhibitor | Available. | Not available. | Not available. |
| Approved for patients with CTCL with progressive, persistent, or recurrent disease after two systemic therapies. | Not approved. | Not approved. | ||
| Brentuximab vedotin | Antibody-drug conjugate | Available. | Available. | Available. |
| Approved for patients with MF or PCALCL expressing CD30 who received previous systemic treatment. | Approved for patients with CD30-positive CTCL who received at least one previous treatment. | Approved for PCALCL or patients expressing CD30 who received previous systemic treatment | ||
| Alemtuzumab | Monoclonal antibody | Available. | Available. | Available. |
| Approved, but does not have a package insert indication for CTCL. | Approved, but does not have a package insert indication for CTCL. | Approved, but does not have a package insert indication for CTCL. | ||
| Mogamulizumab | Monoclonal antibody | Available. | Available. | Not available. |
| Approved for patients with relapsing or refractory MF or SS after at least one previous systemic therapy. | Approved for patients with MF or SS after at least one previous systemic therapy. | Not approved. |
FDA, Food and Drug Administration (https://www.fda.gov/drugs); EMA, European Medical Agency (https://www.ema.europa.eu/en); ANVISA, National Health Surveillance Agency (Agência Nacional de Vigilância Sanitária; http://portal.anvisa.gov.br/); CTCL, Cutaneous T-Cell Lymphomas; MF, Mycosis Fungoides; HDAC, histone deacetylase; PCALCL, Primary Cutaneous Anaplastic Large Cell Lymphoma; SS, Sézary Syndrome.