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March 18, 2019

EC approves Merck’s Keytruda for metastatic squamous NSCLC

The European Commission (EC) has approved Merck’s anti-PD-1 therapy Keytruda as a first-line treatment for adults with metastatic squamous non-small cell lung cancer (NSCLC).

The European Commission (EC) has approved Merck’s anti-PD-1 therapy Keytruda as a first-line treatment for adults with metastatic squamous non-small cell lung cancer (NSCLC).

The indication covers the use of a 200mg dose of Keytruda, in combination with chemotherapy – carboplatin and either paclitaxel or nab-paclitaxel, every three weeks until disease progression or unacceptable toxicity.

EC approval is based on findings from the Phase III KEYNOTE-407 clinical trial that compared Keytruda plus carboplatin-paclitaxel or nab-paclitaxel with carboplatin-paclitaxel or nab-paclitaxel alone in a total of 559 participants.

The Keytruda combination with chemotherapy was observed to significantly improve overall survival (OS) in adults with metastatic squamous NSCLC, irrespective of their PD-L1 tumour expression status.

“With this approval, more patients with non-small cell lung cancer may have the opportunity to benefit from combination therapy with Keytruda.”

The combination decreased the risk of death by 36% when compared to chemotherapy alone.

Merck Research Laboratories chief medical officer Roy Baynes said: “Keytruda provides a foundation for the treatment of lung cancer in Europe, and this approval expands our first-line combination indications to include adults with metastatic squamous non-small cell lung cancer.

“This is a meaningful treatment advance as an anti-PD-1 combination therapy is now approved in Europe for this type of non-small cell lung cancer. With this approval, more patients with non-small cell lung cancer may have the opportunity to benefit from combination therapy with Keytruda.”

In Europe, Keytruda is also approved for the first-line treatment with pemetrexed and platinum chemotherapy in adults having metastatic non-squamous NSCLC and no EGFR or ALK-positive mutations.

It can also be used as monotherapy for metastatic squamous or non-squamous NSCLC in adults having tumours with high PD-L1, without EGFR or ALK-positive tumour mutations.

The drug is also indicated for treating adults with locally advanced or metastatic NSCLC and PD-L1 expressing tumours, after at least one previous chemotherapy regimen.

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