Pfizer Oncology Asia Chief Jorge Puente On Asia’s Role In Xalkori’s Success: An Interview With PharmAsia News (Part 2 of 2)
This article was originally published in PharmAsia News
Jorge Puente, Pfizer’s regional president, Asia Pacific and Canada, Oncology BU, discusses the origins of the NSCLC therapy Xalkori, and how Asian clinical trials helped turbo-charge development of the oral, small molecule inhibitor of c-Met and ALK.
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Pfizer’s Xalkori may be a model for fast development of a targeted oncologic and companion diagnostic, but that model is likely to be more aspiration than reality for future drug/diagnostic combinations. Extensive co-operation was required to keep two sponsors and two review centers on the same page – an effort that reflected the drug’s highly promising efficacy in early studies and FDA’s confidence that confirmatory studies would back up an accelerated approval.
FDA is showing for the second time in as many weeks that all things are possible when it comes to clearing targeted oncologics with compelling evidence. The agency cleared Pfizer’s Xalkori (crizotinib) for late-stage non-small cell lung cancer Aug. 26, just under five months from submission and based on early stage evidence.
Seeing a gap between the large infrastructure being built in China by multinational and domestic companies, Ascendancy hopes to be an interface to help China access drugs from the West.