FDA approves Gilead’s blood cancer drug
pharmafile | July 24, 2014 | News story | Research and Development, Sales and Marketing | Cancer, FDA, Gilead, blood, follicular lymphoma and small lymphocytic lymphoma, lymphocytic leukaemia, sovaldi, zydelig
The Food and Drug Administration has approved Gilead Sciences new treatment Zydelig (idelalisib) to treat three types of blood cancer.
The US regulator has given the all clear to the drug for patients with forms of chronic lymphocytic leukaemia, follicular lymphoma and small lymphocytic lymphoma.
Bruce Cheson who is a Professor of Medicine and head of Haematology and director of its research at Lombardi Comprehensive Cancer Center at Georgetown University in the US, says: “Zydelig is a much needed new treatment option for appropriate patients with CLL and these indolent lymphomas who have experienced relapses and have limited, if any, treatment options.”
Zydelig’s approval is based on a study showing that adding the drug to another cancer therapy – namely Roche’s Rituxan – slowed cancer progression. Patients taking the Zydelig combination lived 10.7 months without their disease progressing, compared with about 5.5 months for patients taking Rituxan alone.
California-based Gilead seems to be riding high waves of success lately with this latest news adding to a strong performance from its once-daily, oral hepatitis C treatment Sovaldi, which is seen as a real breakthrough drug.
Sovaldi (sofosbuvir) which costs $1,000 per pill, was shown the green light from the European Commission in January a month after being approved in the US.
Some analysts have estimated that Zydelig could eventually reach annual sales between $1 billion and $2 billion per year for the firm, whose shares also rose yesterday with the news.
“Gilead is committed to the development of novel cancer therapies and we are proud to have this opportunity to make a difference in the lives of people living with these cancers,” says John Martin, chairman and chief executive at Gilead.
Brett Wells
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