With the handwriting on the wall apparently reading "no go," GlaxoSmithKline ($GSK) has pulled its application for an expanded use of its cancer drug Tykerb for breast cancer patients less two weeks before the FDA was set to issue its recommendation. It was a disappointing move for a company that is working to broaden its cancer drug portfolio.
GSK was hoping for an expanded use, and additional sales, by having Tykerb paired up with Roche's ($RHHBY) Herceptin for women with advanced breast cancer, Reuters reports. The company says it will wait to see what further clinical studies of the targeted cancer drug indicate.
"Our discussions with FDA highlighted questions that could not be addressed with the data currently available," Rafael Amado, GSK's head of oncology R&D, tells Reuters.
This is one in a number of rebuffs for the drug. The U.K.'s National Institute for Health and Clinical Excellence (NICE) on June 27 turned down Tyverb, as it is marketed in Europe, and Herceptin for inclusion in the U.K.'s National Health System. The regulator said there was no indication they would work better than existing drugs as a first-line treatment. And because they are not cheaper, there is nothing to recommend them. Herceptin has already been approved by NICE for treatment in later stages. As for GSK and Tyverb, this was perhaps the third time it has failed to get approval; NICE just doesn't like the price.
In September, GSK halted the dosing of women with Tykerb alone in a clinical study, which was one arm of its trial testing the drug against and in combination with Herceptin. It said preliminary data showed subjects on this solo treatment weren't likely to do as well as those taking Herceptin only.
GSK has been hoping the use would give it more reach in the cancer drug market, which has been estimated at $47.7 billion and growing. The market is dominated by Roche. In April, GSK did get FDA approval for its cancer treatment Votrient for soft-tissue sarcomas, the first new treatment in decades for that condition.
- see the Reuters story
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