Diagnostics, Pharma

Gilead Sciences holding off on six trials for its cancer drug Zydelig due to concerns of adverse effects and deaths

The FDA issued an alert about the drug on Monday, and in the warning it warned healthcare professionals that the drug is not approved for previously untreated chronic lymphocytic leukemia.

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Gilead Sciences had put a hold on six trails for its cancer drug Zydelig because of concerns with adverse effects and even potential deaths. This cancellation has raised questions about the viability of this treatment moving forward.

The FDA issued an alert about the drug on Monday, and in the warning it warned healthcare professionals that the drug is not approved for previously untreated chronic lymphocytic leukemia.

Zydelig received regulatory approval in the U.S. in 2014 for three blood cancers. The drug has been used in combination with Roche’s Rituxan to treat non-Hodgkin lymphoma. So far, Zydelig has brought in $132 million in revenue its is first year on the market.

Despite putting a hold on the drug, Nathan Kaiser, a spokesman for Gilead told ABC News that the company is still conducting a review and ongoing studies that will be looked at by regulatory authorities.

It isn’t clear how many people were negatively affected by the drug or the number of people who may have died due to it.

Combination approaches are standard for cancer treatment, according to Geoffery Borgers, an analyst with Leerink Partners. So issues with a drug like Zydelig could hurt long-term growth for a company like Gilead, although company stock hasn’t really taken a hit thus far.

Photo: Flickr user thematthewknot

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