CRED 8 Presentations
01/07/2024
Lartruvo soft tissue sarcoma – No confirmation of benefit leads to withdrawal
22 Jul 2016: Olaratumab (Lartuvo) STS MAA under accelerated assessment 51 23 Nov 2016: Conditional MA granted for olaratumab (with doxorubicin) for advanced STS 53 18 Jan 2019: ANNOUNCE (N=509) did not meet its primary endpoints 54, 55, 56 1 Feb 2019: CHMP referred olaratumab for review under Article 20 of Regulation (EC) No 726/2004 58 25 Apr 2019: Eli Lilly announced plans to withdraw olaratumab from the market 59 26 Apr 2019: EMA recommended withdrawal of olaratumab from the market 60 19 Jul 2019: EC withdraws olaratumab - issues a binding decision applicable in all EU Member States 61
The first time a conditional approval has been withdrawn Cox et al. Clin Transl Scie 2020;13(3):451-461
The Organisation for Professionals in Regulatory Affairs
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MAA’s Positive vs Negative Outcome Jan 2016 – Dec 2022
Initial MAA 704
Positive 590
Negative 26
Withdrawn 88
ODD 133
Generic 144
Biosimilar 60
The Organisation for Professionals in Regulatory Affairs
Data from EMA Annual Report and CHMP Highlights
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