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FDA panel backs GSK sarcoma drug, disappointing Merck

Votrient moves step closer to US approval but Taltorvic fails to win regulatory advisors' backing

GlaxoSmithKline moved a step closer to securing US approval for Votrient (pazopanib) in advanced soft tissue sarcoma patients after an FDA panel voted 11-2 in support of the firm's marketing application.

There was disappointment for Merck & Co, however, when the same panel voted 13 to 1 against approving its Taltorvic (ridaforolimus) agent as maintenance therapy in metastatic soft tissue or bone sarcoma patients.

There has been speculation ahead of the meeting that both drugs might get a grilling by the Oncologic Drugs Advisory Committee (ODAC), given their limited effects on survival and side effect profiles.

In the event, the ODAC concluded the benefits of Votrient in advanced soft tissue sarcoma patients who had received prior chemotherapy outweighed the risks, as treatment options for this group of patients are limited. They came to this decision despite a discontinuation rate of 14 per cent in a phase III trial because of Votrient's side effects.

Standing in its favour is that Votrient has already been approved in the US to treat renal cell carcinoma since 2009, so clinicians are experienced in using the drug. The FDA reviewers had expressed concern ahead of the meeting that Votrient had no effect on overall survival, despite extending progression-free survival.

The panel was less impressed with Merck and partner Ariad Pharmaceuticals' data on Taltorvic, even though the companies were seeking approval only for use in patients who had already undergone at least four cycles of chemotherapy.

A key sticking point was that Taltorvic is intended as maintenance therapy, in other words to repress recurrence of the sarcoma in patients currently in remission. The ODAC concluded that in these patients the side effect burden of Taltorvic was too high, given there was no effect on survival.

All told, 82 per cent of patients on Merck's drug developed stomatitis, while serious reactions such as pneumonitis, renal failure and hypersensitivity reactions each occurred in 10 per cent of those receiving the drug. Half of all patients treated with Taltorvic discontinued therapy because of adverse reactions.

The FDA is scheduled to make a decision on Votrient on or before May 6, and for Taltorvic no later than June 5.

22nd March 2012

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