XALKORI case study

TIGCRU was asked to write a case study detailing the development and commercialization of XALKORI ® (crizotinib), Pfizer's non-small cell lung cancer drug.

XALKORI ®, the product of a personalised healthcare approach, achieved FDA approval in August 2011, just three years after starting clinical trials.

This was only the third time FDA had approved a drug simultaneously with a companion diagnostic. The first was HERCEPTIN ® / HercepTest in 1998; the second was ZELBORAF ® / Cobas 4800 BRAF V600E earlier in the same month as XALKORI ® / ALK.

Using a mix of interviews and publicly available information TIGCRU delved deep to compile a 7000 word document with some 44 references.

The case study encompassed details across key aspects of development and launch strategy to include

• Intellectual Property

• Clinical development

• Regulatory perspective

• Diagnostic development

• Commercial strategy

• Early market and customer reaction

• Potential future scenarios

The case study was very well-received, and the client intends to update it over time, so it can continue to act as a resource to inform their personalised healthcare strategy.