Amatuximab: FDA Approves New Drug For Malignant Pleural Mesothelioma Treatment In November 2012

The FDA has approved Amatuximab to treat patients with malignant pleural mesothelioma, the most common form of mesothelioma (sometimes referred to as “meso” for short).

In more detail, Amatuximab (MORAb-009) is a monoclonal antibody designed to target mesothelin, a cell surface glycoprotein associated with cell adhesion that is overexpressed in certain types of cancer, including:

  • mesothelioma;
  • lung adenocarcinoma;
  • epithelial ovarian cancer; and,
  • pancreatic ductal adenocarcinoma.

Amatuximab was given “orphan” status by the FDA because it is a new therapeutic agent which treats a disease that affects fewer than 200,000 patients in the United States.   It is estimated there will be 2500 to 9300 new cases of mesothelioma diagnosed each year over the next couple of decades here in the U.S., alone.

According to the most recent data from the National Cancer Institute’s Surveillance Epidemiology and End Results (SEER) Program, between 2000 and 2008, the 5-year survival rate for patients with malignant mesothelioma was 7.0% .

From a November 12, 2012 article, “FDA Grants Orphan Drug Status to Amatuximab for Malignant Pleural Mesothelioma”, published online by OncLive:

“We are very pleased to receive orphan drug designation for amatuximab for the potential treatment of malignant pleural mesothelioma,” said Julia Maltzman, MD, Senior Director of Clinical Development at Morphotek Inc., a subsidiary of amatuximab manufacturer Eisai Inc., in a statement. “Ultimately, this antibody has the potential to provide an additional treatment option for patients suffering from an extremely serious disease.”

Results of a multicenter phase II clinical trial of amatuximab in combination with a chemotherapy regimen of pemetrexed and cisplatin were presented at the American Society of Clinical Oncology (ASCO) meeting earlier this year.  See  “Amatuximab, a chimeric monoclonal antibody to mesothelin, in combination with pemetrexed and cisplatin in patients with unresectable pleural mesothelioma: results of a multicenter phase II clinical trial.”, Hassan R, Jahan TM, Kindler HL, et al.,  J Clin Oncol. 2012;30(suppl; abstr 7030).

We will continue to watch for newly approved treatments for mesothelioma here in the U.S. and elsewhere around the world.

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