And now, Immuno-oncology gets EMA’s pre-approval for Lung Cancer

28/06/2016 - 2 minutes

MSD has received EMA pre-approval for its famous anti-PD-1 therapy, Keytruda. It could soon be used to treat non-small cell lung cancer (NSCLC), the deadliest type of cancer. 

msd_keytruda_pembrolizumab_lung_cancerCheckpoint inhibitors are a key strategy in the hype field of immuno-oncology. This kind of cancer therapy blocks the natural ‘safety checks’ of the immune system – so they cannot be hijacked by cancer cells to escape treatment.

Of these ‘safety checks’, the protein PD-1 is the most popular target. This is the mechanism of action of Keytruda (pembrolizumab), one of the very few checkpoint inhibitors on the market. It’s also the star of MSD’s Biotech side.

Keytruda has now received EMA pre-approval. Should it be approved by the European Commission, it will be able to treat advanced non-small cell lung cancer (NSCLC) in adults whose tumors express PD-L1 (another immune checkpoint protein, which also has checkpoint inhibitors of its own).

This pre-approval follows the results of two clinical trials: a Phase I study assessing rates of overall response (KEYNOTE-001) and a Phase II/III studying overall survival (KEYNOTE-010).

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