Masitinib Receives Another Negative Opinion in Europe

Zosia Chustecka

Disclosures

January 24, 2014

A second negative opinion for the tyrosine kinase inhibitor masitinib (Masiviera, AB Science) has been issued by the Committee for Medicinal Products for Human Use (CHMP), which considers drugs for approval in the European Union. The manufacturer had applied for approval of the drug for use in the treatment of nonresectable locally advanced or metastatic pancreatic cancer, for which it has orphan drug status.

This is the second rejection for the drug. The Committee recently issued another negative opinion for masitinib, this time under the trade name Masican, for its use in the treatment of gastrointestinal tumors.

These negative opinions mean that neither indication is recommended for approval in Europe.

Masitinib does not appear to be marketed anywhere for human use, although it has been available (under the trade name Masivet) for use in dogs as a treatment for mast cell tumors since 2009 in Europe.

Did Not Show Effectiveness

The CHMP noted that the application for the pancreatic cancer indication was made on the basis of a trial that involved 353 patients with advanced or metastatic pancreatic cancer. However, the results of the study "did not show effectiveness in the overall group of patients," it commented.

The company presented analyses suggesting that there was benefit in a subgroup of patients with certain genetic changes associated with more aggressive disease, and in a subgroup of patients with pain. However, the CHMP ruled that the study was not designed to show benefit in these smaller groups, and that further work was needed. The Committee also had concerns about the "significant toxicity" associated with the drug, and about product quality. It concluded that risks outweighed benefits at this time; hence, it recommended that the drug be refused marketing authorization.

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