FDA approves first generic Xeloda
pharmafile | September 17, 2013 | News story | Sales and Marketing | FDA, Roche, Teva, Xeolda, breast cancer, colorectal cancer
The first generic version of Roche’s chemotherapy pill Xeloda has been approved by the US regulator, opening the way for it to take chunks out of the brand’s revenues.
The FDA says Teva Pharmaceuticals USA can market generic capecitabine at 150mg and 500mg: the drug is used to treat metastatic colorectal cancer and metastatic breast cancer.
“This medication is widely used by people living with cancer, so it is important to have access to affordable treatment options,” said Kathleen Uhl, acting director of the office of generic drugs in the FDA’s Center for Drug Evaluation and Research.
The National Cancer Institute says 1.6 million people in the US will be diagnosed with cancer in 2013 and 580,000 of them will die.
Of these, 142,000 will have colon or rectum cancer, with 50,000 dying, while 232,000 women will have breast cancer, 39,000 of whom will die this year.
Xeloda works by activating the cancer-killing agent 5-FU directly inside the cancer cells and its oral form makes it more convenient than other forms of chemotherapy for patients, who require less time in hospital.
Most commonly-observed adverse effects for Xeloda include vomiting, nausea, swelling, fever or infection – and the drug can also exacerbate the effects of blood-thinners such as warfarin.
The approval is a potentially lucrative victory for Teva: a subsidiary of the Israeli generics giant, the US arm was formed in 1996 and is headquartered outside Philadelphia, with 30 facilities across North America.
Roche is now pinning hopes on its ‘smart bomb’ breast cancer drug Kadcyla, which has been approved by the FDA, giving it hope of replacing revenue lost by Xeloda and its blockbuster Herceptin from 2015.
Kadcyla (trastuzumab emtansine or T-DM1) combines Herceptin and chemotherapy in one molecule and is the first antibody-drug conjugate for treating HER2-positive metastatic breast cancer.
It could make more than $1.1 billion in peak annual sales, analysts say, which would help plug the $6 billion a year set to be eroded by Herceptin’s upcoming patent loss, and trials have shown the combination significantly delayed disease progression and produced fewer side effects.
Elsewhere, Xeloda is approved in Europe in combination with intravenous oxaliplatin for the treatment of patients after they have surgery for early colon cancer.
Adam Hill
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