TIGCRU was asked to write a case study detailing the development and commercialization of ZELBORAF ® (vemurafenib), Roche and Daiichi Sankyo's metastatic melanoma drug.
ZELBORAF ®, the product of a personalised healthcare approach, and companion diagnostic (cobas 4800 BRAF V600 Mutation Test) achieved FDA approval in August 2011, just under five years after starting clinical trials.
This was only the second time FDA had approved a drug simultaneously with a companion diagnostic. The first was HERCEPTIN ® / HercepTest in 1998.
Using a mix of interviews and publicly available information TIGCRU delved deep to compile a 9000 word document with some 66 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.