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Xalkori And The Art Of Modern Drug Development

 
• By Michael Goodman

Pfizer developed crizotinib and its companion diagnostic in just four years after identifying an aberrant ALK gene as the target, spanning a corporate restructuring, the Wyeth integration, and the departure of senior staff in the R&D organization and oncology BU. The next year or so will tell whether Xalkori was a flash in the pan, or whether it marks the long awaited turnaround for Pfizer’s oncology business and a model for nimble drug development.

It is rare to hear of a scientific discovery turning into a marketed product in just four years. But that’s what Pfizer Inc. managed to do with Xalkori (crizotinib), its oral, small molecule inhibitor of c-Met and ALK. The ALK discovery came to light in August 2007, and was well-timed for Pfizer, which had crizotinib in development as a c-MET inhibitor – unsuccessfully. But Pfizer, a pharma giant that has seen more than its share of development failures, was able to turn the program around and obtain an unprecedented approval based on Phase I data a mere four years after identifying an ALK rearrangement as the target. It remains to be seen whether the speed and sure-footedness of that approval can be replicated, or if it was a rare case of capturing lightning in a bottle.

What is remarkable about the crizotinib development program was Pfizer’s ability to capitalize on a scientific discovery. It took a...

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