Julie Lepin
Julie is Senior Vice President at Sana Biotechnology, with over 20 years of global regulatory experience defining regulatory strategies for both drug development and marketing authorization activities. She has broad regulatory agency experience ranging from pre-filing meetings, scientific advice and MAA review/approval discussions and advisory committee meetings across major markets including USA, Europe, Japan, Canada and numerous Emerging Markets around the globe.
JournalExploring Amgen’s Project Orbis experience with sotorasib (Part 2)
On 28 May 2021, sotorasib (LUMAKRAS™/LUMYKRAS®), a novel, first-in-class, inhibitor of the RAS GTPase family became the first drug to be approved by the US Food and Drug Administration (FDA) to target Kirsten rat sarcoma proto-oncogene (KRAS) G12C, a target that was considered undruggable for 40 years. Sotorasib is indicated ...
JournalAmgen’s experience of global expedited regulatory pathways in the development of sotorasib (Part 1)
On 28 May 2021, sotorasib (LUMAKRAS™/LUMYKRAS®), a novel, first-in-class, inhibitor of the RAS GTPase family became the first drug to be approved by the US Food and Drug Administration (FDA) to target Kirsten rat sarcoma proto-oncogene (KRAS) G12C. For 40 years, this condition had been considered undruggable. Sotorasib became the first approved targeted therapy for the treatment of adult patients, with previously treated KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC). The approval was achieved in less than three years from first in human (FIH) exposure. This case study provides regulatory insights into the global expedited pathways and special designations, which were utilised during the development and marketing application review.