New drug prevents chemo-induced nausea, vomiting in most cancer patients

Teresa Tanoos's picture
FDA approves new combo drug for chemo-induced nausea and vomiting.

There’s new hope for patients suffering from the debilitating side effects of chemotherapy for cancer, which often includes severe nausea and vomiting, as the Food and Drug Administration (FDA) announced its approval today of a novel combo drug to prevent CINV (short for chemotherapy-induced nausea and vomiting).

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The new product, called Akynzeo, is administered orally as a capsule containing a unique fixed-dose combination of two drugs, netupitant and palonosetron. Researchers found that just one dose consistently prevents CINV in the majority of cancer patients receiving chemotherapy.

The two-drug combo product appears to work by zeroing in on specific pathways in the body, which trigger the intense nausea and vomiting linked to chemotherapy.

The older of the two drugs, palonesetron (approved by the FDA in 2008), prevents chemo-induced nausea and vomiting during the first 24 hours (the acute phase). The newer drug, netupitant, prevents CINV within both the acute phase and the delayed phase, which occurs from 25 to 120 hours after chemotherapy is initiated.

Testing of Akynzeo was conducted on 1720 cancer patients undergoing chemotherapy treatment. Results of the testing, published recently in the Annals of Oncology, showed the novel combo drug was highly effective in most of the cancer patients.

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The testing also demonstrated that the combination of the two drugs worked better to prevent chemo-induced nausea and vomiting than just palonosetron alone.

Indeed, the two-drug combo worked so well, that 98.5 percent of the cancer patients who received it did not have any nausea or vomiting at all during the first 24 hours of starting chemotherapy, known as the acute phase, compared with 89.7 percent of those who received palenosetron only.

The percentage of cancer patients not experiencing any nausea and vomiting within the next 25 to 120 hours (the delayed phase of CINV) was 90.4% for those on the combo drug, compared with 80.1% for those on palenosetron alone. Two different clinical trials were conducted, and both showed similar results.

As for side effects from Akynzeo, the most common reported by patients participating in the trials were asthenia, constipation, fatigue, headache and indigestion dyspepsia.

SOURCE: FDA News Release: FDA approves Akynzeo for nausea and vomiting associated with cancer chemotherapy, published Oct. 10, 2014.

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