Merck's Keytruda Gets EU Approval For Difficult Lung Cancer
Zacks Investment Research | Mar 14, 2019 11:28PM ET
Merck & Co., Inc. (NYSE:MRK) announced that the European Medicines Agency (“EMA”) has approved the label expansion of its blockbuster PD-1 inhibitor, Keytruda (pembrolizumab). The drug is now approved in combination with chemotherapy (carboplatin and either paclitaxel or nab-paclitaxel) for the first-line treatment of adult patients with metastatic squamous non-small cell lung cancer (“NSCLC”) — a difficult to treat lung cancer population — regardless of PD-L1 expression.
The European approval was expected as the Committee for Medicinal Products for Human Use had recommended the same in February.
Following the recent approval, the Keytruda combo is now the first anti-PD-1 therapy to be approved in the EU for adult patients affected by metastatic squamous NSCLC.
The approval was based on data from the phase III KEYNOTE-407 study. Data from the study showed that the combination of Keytruda plus chemotherapy led to a significant improvement in both overall survival (“OS”) and progression-free survival rates compared with patients receiving only chemotherapy. Results presented from this study stole the limelight at the annual meeting of the American Society of Clinical Oncology last June.
In the United States, a similar label expansion was approved last October. This nod will help Merck gain access to a broader lung cancer patient population and boost sales of its blockbuster drug.
Please note that the drug is under review in the United States for label expansion as monotherapy for locally advanced or metastatic non-squamous or squamous NSCLC patients with PD-L1 expression. A decision is expected next month.
Shares of Merck have increased 6.6% so far this year, compared with the industry ’s gain of 3.5%.
Keytruda is already approved for many types of cancers and treatment settings including lung cancer, melanoma, head and neck cancer, classical Hodgkin’s lymphoma and bladder cancer. The company is also developing the drug as a treatment for several other oncology indications including different lung cancers in multiple settings.
Keytruda is the largest product in Merck’s portfolio and has recorded impressive growth rate since its launch in 2014. The drug generated sales of $7.17 billion in 2018, reflecting a massive increase of 88% year over year. Sales were driven by the launch of the drug for new indications globally. Keytruda sales are particularly gaining from a strong momentum in first-line lung cancer indication as it is the only anti-PD-1 medicine approved in the first-line setting.
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