All Expedited drug regulatory pathways articles
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CPD SupplementThe Olaratumab experience
As highlighted within this CPD article, a conditional marketing authorisation (CMA) can be revoked in Europe. However only one occurrence has occurred since 2006 (in April 2019). Lartruvo (olaratumab), a humanised antibody, was granted a CMA via accelerated assessment on 9 November 2016 for adult patients with a locally advanced, ...
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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.
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CPD SupplementExpedited drug development regulatory pathways in the EU and the US
This continuing professional development (CPD) supplement focuses on the regulatory framework available to drug developers for expediting their products’ development and review processes in the EU and US. These mechanisms are relevant for products which address an unmet medical need in the treatment of a serious and/or life-threatening condition.