Merck & Co.'s Keytruda approved in EU in combination with chemotherapy as first-line treatment for NSCLC

Merck & Co. said Thursday that the European Commission approved Keytruda (pembrolizumab), in combination with carboplatin and either paclitaxel or Celgene's Abraxane (nab-paclitaxel), for the first-line treatment of adults with metastatic squamous non-small-cell lung cancer (NSCLC). Merck noted that the product is the first anti-PD-1 therapy authorised in the EU in combination with chemotherapy in this indication regardless of PD-L1 expression.

Approval of the drug was supported by findings from the late-stage KEYNOTE-407 trial, results of which showed that the combination of Keytruda and chemotherapy reduced the risk of death by 36 percent versus chemotherapy alone in adults with metastatic squamous NSCLC irrespective of PD-L1 tumour expression status. Results demonstrated that median overall survival was 15.9 months in the Keytruda and chemotherapy arm, versus 11.3 months for chemotherapy alone, while the median progression-free survival times in these groups were 6.4 months and 4.8 months, respectively.

Keytruda was previously cleared for this same indication in the US and Japan. Sales of the product in the fourth quarter of 2018 grew 66 percent year-over-year to $2.2 billion, exceeding $2 billion for the first time.

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