Conditional Approval Of New Drug For British Mesothelioma Patients | Shrader Law
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In 2011, the FDA approved the use of Xalkori (crizotinib) to treat patients who have late-stage, non-small cell lung cancers (NSCLC) who express the abnormal anaplastic lymphoma kinase (ALK) gene. Recently, the European Commission also approved the drug, made by Pfizer, for this use. Now, researchers are working to determine whether this biomarker is also present in some patients with pleural mesothelioma, which would make Xalkori the newest mesothelioma treatment option.

Mesothelioma is a rare form of cancer that is caused by exposure to asbestos and affects the membranes (mesothelial cells) that surround many of the body’s organs. Pleural mesothelioma, which affects the membranes around the lungs, is the most common form of this incurable disease. In many cases, treatment options for pleural mesothelioma are similar to those used for certain types of lung cancer, and may include chemotherapy and radiation.

An article in Pharma Times states that the Commission’s approval requires that Pfizer submit data from a recent Phase III PROFILE 007 trial to the European Medicines Agency for review. Once this information is reviewed, the Commission may give the drug conditional clearance.

To determine whether Xalkori will be beneficial to a patient, doctors first need to identify whether the patient has the abnormal ALK gene by conducting a companion diagnostic test with a Vysis ALK Break Apart FISH Probe Kit. This is a leading edge genetic test, and the patient must be determined to have the gene in question before he or she can be prescribed the twice-daily pill.

According to, 3.13% of UK non-small cell lung cancer patients have ALK fusion genes, and these patients also have a historically poor response to current therapies. Pfizer went on record in the past to report that each year, nearly 10,000 of the 220,000 Americans diagnosed with lung cancer could see some benefit from treatment with Xalkori.

The National Cancer Institute defines a biomarker as “a biological molecule found in blood, or other body fluids, or tissues that is a sign of a normal or abnormal process, or of a condition or disease.” For years, researchers and doctors have used biomarkers to aid in the diagnosis and treatment of diseases, including mesothelioma and a number of other cancers. By identifying a biomarker, physicians may be lead to consider treatments that may not have been an option otherwise.

Xalkori represents a “major advancement” in the field of metastatic NSCLC, according to Jean-Charles Soria, professor of Medicine and Medical Oncology at South-Paris University and cancer specialist at Institut Gustave Roussy, France (as quoted in the Pharma Times article).

Data from the Health and Safety Executive, more than 40,000 Great Britians have died from mesothelioma since the late 1960’s, and this number is expected to continue to grow. The number of deaths from mesothelioma in Britian is higher than in any other country.