Module 19: Regulation of In Vitro Diagnostic Medical Devices

13/04/2023

The importance of personalised medicine

• Unpublished MHRA review of European new drug (new active substance) approvals 2015-2019 There were 173 new drug approvals during these 5 years • For 35 products ( 20% ), the approved indication is for a biomarker-defined disease subset •

New EU/EEA Drug Approvals 2015 2019

Biomarker defined disease subset Rare genetic disorders

20%

14%

62%

4%

Advanced therapies

→ Mandatory biomarker test

→ CDx needs to be available

The Organisation for Professionals in Regulatory Affairs

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EGFR activating mutation and gefitinib

Figure 1: Comparison of gefitinib and carboplatin/paclitaxel treatment arms for progression-free survival based on their EGFR mutations status (IPASS study)

• Iressa ® (gefitinib) is approved for the treatment of advanced non

small cell lung cancer with activating mutations of EGFR

• The EGF and its receptor are key drivers of cell proliferation

Gefitinib inhibits the EGFR tyrosine kinase

•

→ Mandatory biomarker test → No drug without CDx

The Organisation for Professionals in Regulatory Affairs

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