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Industry Buzz: Saladax Releases Gleevec Companion Diagnostic

by | Feb 23, 2015 | Essential, Industry Buzz-lir, Laboratory Industry Report

Pennsylvania-based Saladax Biomedical has launched a new test intended to better gauge cancer patients’ receptivity to a well-known chemotherapy drug. The blood-based companion diagnostic assay, known as MyImatinib, measures patient sensitivity to imatinib, which is marketed in the United States as Gleevec. That drug is used to treat leukemia, gastrointestinal stromal tumors, and other forms of cancer. However, determining Gleevec dosage—as with other chemotherapy medications—has been a challenge. Most dosing methodology has been based on determining the surface of the patient’s body based on their height and weight. That methodology is nearly 100 years old and has been used since chemotherapy drugs were introduced a half-century ago. Some studies have suggested that with some forms of cancer, underdosing approaches 70 percent. In the United States, about 65 percent of cancer patients undergo chemotherapy regimens during the course of their treatment. Large percentages of those patients will eventually wind up visiting hospital emergency rooms or be admitted as inpatients, according to data from the health care research firm Milliman. For Gleevec, dosages for patients can range from 100 milligrams to 800 milligrams a day depending on their particular affliction, according to Novartis Pharmaceutical Corp., the company that manufactures and markets the […]

Pennsylvania-based Saladax Biomedical has launched a new test intended to better gauge cancer patients’ receptivity to a well-known chemotherapy drug. The blood-based companion diagnostic assay, known as MyImatinib, measures patient sensitivity to imatinib, which is marketed in the United States as Gleevec. That drug is used to treat leukemia, gastrointestinal stromal tumors, and other forms of cancer. However, determining Gleevec dosage—as with other chemotherapy medications—has been a challenge. Most dosing methodology has been based on determining the surface of the patient’s body based on their height and weight. That methodology is nearly 100 years old and has been used since chemotherapy drugs were introduced a half-century ago. Some studies have suggested that with some forms of cancer, underdosing approaches 70 percent. In the United States, about 65 percent of cancer patients undergo chemotherapy regimens during the course of their treatment. Large percentages of those patients will eventually wind up visiting hospital emergency rooms or be admitted as inpatients, according to data from the health care research firm Milliman. For Gleevec, dosages for patients can range from 100 milligrams to 800 milligrams a day depending on their particular affliction, according to Novartis Pharmaceutical Corp., the company that manufactures and markets the drug. In some cases, such as for gastrointestinal stromal tumors, the regimen can last for years. Side effects for the medication can range from nausea to edema, although in some cases large doses of the Gleevec have been linked to congestive heart failure. “Our own analysis shows that, in general, 50 percent of patients are not receiving an optimal chemotherapy dosage, which reduces the effectiveness of the treatment or causes significant toxicity,” said Saladax Chief Executive Officer Kevin Harter. Along with the MyImatinib test, Saladax also has marketed assays to determine appropriate dosages for 5-fluorouracil, pacilitaxel, and docetaxel. The company has said that it is developing at least nine other blood-based companion diagnostic tests for cancer patients to be released in the near future. Takeaway: Saladax is continuing to expand its portfolio of drugs intended to pinpoint chemotherapy treatments. 

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