All Accelerated approval articles
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JournalThe changing face of oncology development – is cancer still ‘different’? A US perspective
Oncology development has traditionally been thought of as ‘different’; that the rules that applied to other therapy areas were not necessarily applicable to the development of treatments for cancer patients, who until relatively recently, had exceedingly limited treatment options. Dose finding was based on the paradigm adopted for cytotoxics and ...
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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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FocusConditional oncology drug approvals: A sponsor’s perspective on the evolving landscape of FDA accelerated approvals
The FDA’s accelerated approval (AA) pathway is an important regulatory mechanism that allows patients with serious or life-threatening conditions, potentially earlier access to treatments than under a standard, regular approval development pathway...
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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.