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The first time a conditional approval has been withdrawn Cox et al.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Withdrawn 88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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