Reason for request

Extension of indication

High clinical benefit and moderate clinical added value compared to platinum salt-based bitherapy as first-line treatment for metastatic non-small cell lung cancer

 

 

  • KEYTRUDA has been granted a marketing authorisation for the first-line monotherapy treatment of adults suffering from metastatic non-small cell lung cancer (NSCLC) with tumours expressing PDL1 at the threshold ≥ 50%, without EGFR or ALK tumour mutation.

  • As a monotherapy, its superiority has been demonstrated over platinum salt-based bitherapy in terms of progression-free survival in the patient population with a

    PD-L1 tumour expression of ≥ 50%.

  • Its safety profile is superior to that of platinum salt-based chemotherapy.

  • It is a first-line treatment for this population.

 

 


Clinical Benefit

Substantial

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Clinical Added Value

moderate

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