FDA Grants Approval to Valchlor

By: Taylor


August 26, 2013 – The U.S. Food and Drug Administration (FDA) granted marketing approval for Ceptaris Therapeutics, Inc. new drug VALCHLOR™ (mechlorethamine). Valchlor comes in gel form and is used as a topical treatment of stage IA and IB mycosis fungoides-type cutaneous T-cell lymphoma (CTCL) in those patients who have already received a skin-directed therapy.

In the past, the FDA has approved other forms of topical treatments for CTCL, however VALCHLOR™ is the first and only topical mechlorethamine product to be FDA approved. VALCHLOR™ is a topical gel which is applied once a day and dries on the skin, it is commonly known as ‘nitrogen mustard’.

Leading researchers in the field of skin cancer were quoted as saying: “This is good news for patients and the treatment community. We now have the confidence of a FDA-approved product backed by evidence from a well-controlled clinical trial that demonstrated clinically meaningful responses in the majority of patients with stage IA and IB mycosis fungoides-type cutaneous T-cell lymphoma (CTCL) who have received prior skin-directed therapy.”

The approval of VALCHLOR™ will allow medical and health care professionals to treat patients with stage IA and IB mycosis fungoides-type CTCL who have received prior skin-directed therapy with a FDA-approved version of topical mechlorethamine. In addition to consistent, controlled manufacturing processes, VALCHLOR™ will be provided with labeling, which includes data and instructions for proper use to help achieve the best possible clinical results.

Mechlorethamine was previously approved by the FDA as a chemotherapeutic agent to be used intravenously for the treatment of mycosis fungoides, the most common type of CTCL. This new topical form is recommended for the treatment of early stage CTCL by the National Comprehensive Cancer Network. The drug will be accompanied by labeling which will include data as well as instructions for doctors and patients which will assist them in achieving the best possible results.

About CTCL

Mycosis Fungoides – also known as Alibert-Bazin syndrome or granuloma fungoides – is the most common form of cutaneous T-cell lymphoma (skin cancer) and generally affects the skin, however over time it may progress internally. Symptoms of mycosis fungoides-type cutaneous T-cell lymphoma include rash, tumors, skin lesions and itchy skin. The name Mycosis Fungoides is a misleading name. Loosely translated it means ‘mushroom like fungal disease’ and was so named for its mushroom like appearance. However, Mycosis Fungoides is not a fungal infection but is a type of non-Hodgkin’s lymphoma.

The stages of CTCL is defined by the characteristics if four components, skin, nodes, visceral and blood.

Stage IA is defined as:

Skin: Limited patches papules and or plagues covering less than 10 percent of the skins surface.
Nodes: No abnormal peripheral lymph nodes – no biopsy required
Visceral: Visceral organs are not involved
Blood: Either an absence (less than 5%) of blood involvement up to a low blood tumor level where blood lymphocytes cells do not meet the criteria of a high tumor burden.
Stage IB is defined as:

Skin: Limited patches, papules and or plagues covering up to greater than 10% of the skins surface.
Nodes: No abnormal peripheral lymph nodes – no biopsy required
Visceral: Visceral organs are not involved
Blood: Either an absence (less than 5%) of blood involvement up to a low blood tumor level where blood lymphocytes cells do not meet the criteria of a high tumor burden.

For more information visit: http://www.unsafedrugs.com/fda-grants-approval-valchlor-gel-treatment-early-stage-ctcl/

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