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22-12-2021 | EMA | News

Tepotinib, lorlatinib receive EMA nod

Author: Shreeya Nanda


medwireNews: The EMA’s Committee for Medicinal Products for Human Use (CHMP) has recommended tepotinib for marketing authorization and suggested adopting a new indication for lorlatinib, both in non-small-cell lung cancer (NSCLC).

The opinion document states that the MET inhibitor tepotinib should be used for the treatment of adults with advanced NSCLC and MET exon 14 skipping mutations after progression on immunotherapy and/or platinum-containing chemotherapy.

The committee highlights the benefits of tepotinib in this patient population, namely the objective response rate and response duration, as demonstrated in the phase 2 VISION trial.

Tepotinib was approved for use in this population by the US FDA in February 2021.


Following the recommendation by the CHMP to change the terms of the marketing authorization, the ALK–tyrosine kinase inhibitor (TKI) lorlatinib is now indicated for adults with ALK alteration-positive, advanced NSCLC that has not previously been treated with an ALK inhibitor.

Previously lorlatinib could only be given to patients who had either received alectinib or ceritinib as their first ALK–TKI, or crizotinib and at least one other ALK–TKI.

This first-line indication was previously accepted by the FDA in March 2021 following the phase 3 CROWN trial results.

medwireNews is an independent medical news service provided by Springer Healthcare Ltd. © 2021 Springer Healthcare Ltd, part of the Springer Nature Group


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