VALCHLOR mechlorethamine

Drug Class

Topical alkylating agent

Mechanism

Alkylates DNA and cross-links DNA strands to inhibit DNA replication and induce apoptosis in neoplastic T-cells.

Approved Indication

Topical treatment of Stage IA and IB mycosis fungoides-type cutaneous T-cell lymphoma (MF-CTCL) in patients who have received prior skin-directed therapy.

What This Means For Patients

Valchlor (mechlorethamine gel) is a topical nitrogen mustard chemotherapy gel formulated for patients with early-stage cutaneous T-cell lymphoma (mycosis fungoides). It provides local alkylating action directly on skin lesions. It is available under the special-import policy in the Hainan Boao Lecheng pilot zone.

Regulatory Approvals

• FDA — approved (2013) — label
• EMA — approved (2020) — source

Pivotal Clinical Evidence

• Study 201 — Lessin et al., JAMA Dermatol 2013 (NCT00168064) — DOI

Sources

• https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202714s000lbl.pdf
• https://www.ema.europa.eu/en/medicines/human/EPAR/ledaga