By having the commercial rights of VALCHLOR ® (mechlorethamine) in China, Kyowa Kirin has shown that it is serious about meeting patients' unmet needs in the rare disease therapeutic areas" added Kazunobu Mikawa, General Manager in China (KKCN) , "VALCHLOR ® will be one of our strategic products for our dermatology and hemato-oncology franchise. (pharmiweb.com)
VALCHLOR ® (mechlorethamine) gel is indicated for the 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. (pharmiweb.com)
VALCHLOR ® is contraindicated in patients with known severe hypersensitivity to mechlorethamine. (pharmiweb.com)
If approved, VALCHLOR would be the first topical formulation of mechlorethamine for the treatment of early-stage mycosis fungoides-type cutaneous T-cell lymphoma. (centerwatch.com)
Should the FDA approve VALCHLOR and Actelion acquire Ceptaris, we would be able to offer this medicine to patients who are dependent on formulations prepared locally by compounding pharmacies in a non-standardized environment," said Jean-Paul Clozel, M.D., and chief executive of Actelion. (centerwatch.com)
Chlormethine2
Chlormethine (INN, BAN), also known as mechlorethamine (USAN, USP), mustine, HN2, and (in post-Soviet states) embikhin (эмбихин), is a nitrogen mustard sold under the brand name Mustargen among others. (wikipedia.org)
Recent developments in skin-directed treatments include optimizing the use of existing topical therapies, the introduction of known dermatological agents and treatment modalities for the specific treatment of MF/SS (such as mechlorethamine gel, calcineurin inhibitor creams, and photodynamic therapy), and novel local and topical agents. (bvsalud.org)
Severe1
Though ingestion is uncommon, if mechlorethamine is swallowed it causes severe chemical burns to the gastrointestinal tract and concomitant nausea, vomiting, diarrhea, abdominal pain, and hemorrhage. (wikipedia.org)
Treatment2
A randomized trial comparing combination electron-beam radiation and chemotherapy with topical therapy in the initial treatment of mycosis fungoides. (medscape.com)
Historically, some uses of mechlorethamine have included lymphoid malignancies such as Hodgkin's disease, lymphosarcoma, chronic myelocytic leukemia, polycythemia vera, and bronchogenic carcinoma Mechlorethamine is often administered intravenously, but when compounded into a topical formulation it can also be used to treat skin diseases. (wikipedia.org)
Chlormethine (INN, BAN), also known as mechlorethamine (USAN, USP), mustine, HN2, and (in post-Soviet states) embikhin (эмбихин), is a nitrogen mustard sold under the brand name Mustargen among others. (wikipedia.org)
Mechlorethamine, commonly known as nitrogen mustard, is already approved for intravenous use in the treatment of mycosis fungoides. (medscape.com)
Patients had received at least 1 previous skin-directed therapy, which could have included topical corticosteroids, phototherapy, Targretin gel, or topical nitrogen mustard (mechlorethamine), but they were not required to be refractory to or intolerant of other therapies. (medscape.com)
Development of nitrogen mustard formulations and treatment regimens has been studied extensively over the last 40 years. (nih.gov)
Working Formulation2
The Working Formulation, originally proposed in 1982, classified and grouped lymphomas by morphology and clinical behavior (ie, low, intermediate, or high grade) with 10 subgroups labeled A to J. (medscape.com)
Although considered obsolete, the National Cancer Institute's Working Formulation (IWF) classification is still used, mainly for historical data comparisons. (medscape.com)
Hypersensitivity2
In the last 5 years, a new gel formulation has been developed that is associated with a decrease in delayed hypersensitivity reactions. (nih.gov)
Hypersensitivity reactions, including anaphylaxis, have occurred in approximately 2% of patients who received the IV formulation of melphalan. (medicine.com)
Mycosis2
There have been studies demonstrating that topical administration of mechlorethamine has efficacy in mycosis fungoides-type cutaneous T cell lymphoma. (wikipedia.org)
In general, topical therapies are indicated for stage I patients, and systemic therapies or combinations of topical and systemic therapies are indicated for patients with stage IIB disease or greater, or for patients with stage I mycosis fungoides who are intolerant of topical treatments or whose condition has failed to respond to such treatments. (medscape.com)
Refractory1
Obtain repeated biopsies in patients who have progressive chronic dermatosis or whose condition is refractory to topical treatments. (medscape.com)
Severe1
Though ingestion is uncommon, if mechlorethamine is swallowed it causes severe chemical burns to the gastrointestinal tract and concomitant nausea, vomiting, diarrhea, abdominal pain, and hemorrhage. (wikipedia.org)
Treatments1
Symptomatic treatments (eg, emollients, antipruritics) are used in combination with specific topical and systemic treatments. (medscape.com)
Chronic1
Historically, some uses of mechlorethamine have included lymphoid malignancies such as Hodgkin's disease, lymphosarcoma, chronic myelocytic leukemia, polycythemia vera, and bronchogenic carcinoma Mechlorethamine is often administered intravenously, but when compounded into a topical formulation it can also be used to treat skin diseases. (wikipedia.org)
Patients1
Additionally, data from a small study in patients with either HL or NHL support the use of the propylene glycol-free melphalan formulation (Evomela) as a component of the BEAM regimen in patients with lymphomas eligible for autologous stem cell transplantation Cashen 2016. (medicine.com)
Preparation1
The noninferiority trial compared the proprietary gel formulation with a pharmacy-compounded preparation, and the end point was a confirmed complete response at 6 months, defined as at least a 50% reduction in the Composite Assessment of Index Lesion Severity score. (medscape.com)
Product1
The use of topical mechlorethamine has been documented over several decades, but this is the first time that a product has gone through the rigorous FDA process," noted Stuart R. Lessin MD, former director of dermatology at the Fox Chase Cancer Center in Philadelphia, president of the board of directors at the Cutaneous Lymphoma Foundation, and principal investigator of the clinical trial on which approval of the new product was based. (medscape.com)