Osimertinib (AZD9291)-a science-driven, collaborative approach to rapid drug design and development

Using a science-driven, collaborative approach, osimertinib (AZD9291) was designed to inhibit EGFR in a covalent irreversible manner, while harbouring preferential activity against sensitising and T790M resistance mutations, relative to the wild-type form of the receptor. The clinical development programme for osimertinib is the most rapid to date, taking just 2 years from filing the FDA Investigational New Drug Application to submitting the FDA New Drug Application and just 2 years 8 months and 1 week from the first patient dosed to the first approved indication. The development of osimertinib demonstrates that it is possible to bring drugs rapidly from bench to bedside when supported by clear biological rationale, robust preclinical evidence, flexibility in clinical study design, stakeholder collaboration and engagement with regulatory bodies.