Sancuso® Approved for Chemotherapy-induced Nausea and Vomiting

Posted on March 8th, 2009 by

Sancuso® Approved for Chemotherapy-induced Nausea and Vomiting

The United States Food and Drug Administration (FDA) has approved Sancuso® (Granisetron Transdermal System) for the treatment of chemotherapy-induced nausea and vomiting (CINV). Sancuso is a patch that is placed on the skin and delivers five continuous days of symptom control for patients receiving moderate or highly nausea-inducing therapy.

Although management of CINV has improved over time, both nausea and vomiting remain some of the most severe and prevalent chemotherapy-induced side effects. Acute CINV significantly reduces quality of life during treatment, and delayed CINV affects patients’ ability to perform daily activities after they return home following treatment. Furthermore, metabolic disturbances, such as electrolyte imbalances and/or dehydration, may occur due to CINV, as well as tearing of the esophageal mucosa, re-hospitalization, increased medical costs, and increased demands on healthcare providers for the management of complications associated with CINV. However, one of the most disconcerting consequences of CINV is that patients may refuse cancer treatment because of the distress and/or significant reduction in quality of life caused by CINV; such an occurrence ultimately keeps patients from receiving the best possible treatment.

At the 2008 ONS meeting, 581 oncology nurses were surveyed regarding CINV. More than half of the surveyed nurses (56%) reported that they had stopped or delayed treatment to their patients specifically due to CINV. Furthermore, 70% of the nurses surveyed reported a “zero tolerance” policy towards CINV, while 40% of the physicians these nurses worked with also had a zero tolerance policy. The nurses also stated that CINV is one of the most important factors, behind fatigue, affecting quality of life of cancer patients.

Because approximately 70% of the one million patients diagnosed with cancer annually experience CINV, there remains a critical and unmet need to improve prevention of this debilitating side effect. Additional measures may also be taken to manage CINV. These include discussion between healthcare providers and patients regarding delayed CINV (which occurs following treatment) in order to better prepare patients to manage this condition at home. Another area that may be improved is the method of administration of agents to prevent CINV; because these are often given in the form of injection or oral pills, patients who are already nauseated and vomiting or suffer from mucositis (a common side effect from chemotherapy in which the mucosal lining of the mouth is inflamed or ulcered) may have difficulty receiving preventive care for CINV.

The trial prompting FDA approval of Sancuso included 641 patients who were being treated with chemotherapy that moderately or highly induced nausea. One group of patients was treated with Sancuso, and the other group was treated with the oral form of the active ingredient, granisetron. Sancuso worked just as well as oral granisetron in controlling vomiting or retching and was well tolerated.

Patients who are to undergo chemotherapy may wish to speak with their physician regarding their individual risks and benefits of using Sancuso.

Reference: ProStraken. FDA Approves Sancuso, the first and only patch for preventing nausea and vomiting in cancer patients undergoing chemotherapy. Available at: Accessed September 2008.

Related News: More than Half of Oncology Nurses Stop or Delay Chemotherapy Due to Nausea and Vomiting (6/24/2008)

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