MSD withdraws European application of Keytruda combo in lung cancer

pharmafile | October 30, 2017 | News story | Sales and Marketing |  EMA, MSD, keytruda 

MSD has been forced to withdraw its EU marketing application for Keytruda (pembrolizumab) in combination with pemetrexed and carboplatin as a first-line treatment for metastatic non-squamous non-small cell lung cancer (NSCLC), despite the combination already gaining approval in the US back in May this year.

The company confirmed that this move was due to the inability of the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) to approve the therapy on the back of data generated by the KEYNOTE-021 Phase 2 trial. MSD had previously said that the data demonstrated “significant improvements in overall response rate (ORR) and progression-free survival (PFS) for the Keytruda combination regimen compared to chemotherapy alone”.

Approval in Europe was expected to come sometime next year. The company said that it has not made a decision on when it will resubmit the drug in the space, but opportunities would be available for the company to conduct interim analyses of clinical trial data in the meantime.

Keytruda has so far proven to be one of the hardest-hitting drugs in the immuno-oncology space, exceeding the $1 billion mark for the first time to reach $1.05 billion in sales in the third quarter of 2017, increasing by 194% year on year. The company has also stated that almost a third of all new lung cancer patients in the US are starting treatment with the drug.

Matt Fellows