US FDA approves generic version of Roche’s cancer drug Xeloda

17th September 2013 (Last Updated September 17th, 2013 18:30)

The US Food and Drug Administration (FDA) has approved a generic version of Roche Holding's oral chemotherapy pill, Xeloda (capecitabine).

Cecal adenocarcinoma

The US Food and Drug Administration (FDA) has approved a generic version of Roche Holding's oral chemotherapy pill, Xeloda (capecitabine).

Xeloda is used to treat colorectal cancer that has spread to other parts of the body (metastatic) as well as metastatic breast cancer.

As part of the approval, Teva Pharmaceuticals USA will be responsible for marketing the generic version of Xeloda in 150mg and 500mg doses.

FDA Center for Drug Evaluation and Research's acting director of Office of Generic Drugs Kathleen Uhl said: "This medication is widely used by people living with cancer, so it is important to have access to affordable treatment options."

Common adverse events seen in clinical trials for Xeloda include diarrhea, vomiting, and nausea, as well as oral pain, redness, swelling, and sores, while other events were hand-foot syndrome, fever and infection.

According to FDA, it is important that the prescriber know if the patient is also taking a medicine used to thin the blood, such as warfarin.

The drug is packaged with a boxed warning to avoid co-treatment with blood thinners, which may cause serious adverse events.

Generic drug manufacturing and packaging sites must pass the same quality standards as those of brand-name drugs since generics possess the same quality and strength as brand-name drugs.


Image: A micrograph of an invasive cecal adenocarcinoma. Photo: courtesy of Nephron.