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.