Pembrolizumab (Keytruda, Merck & Co) has been recommended for approval in Europe for first-line use in non–small cell lung cancer (NSCLC), the first such move worldwide.
The drug received a positive opinion from the Committee for Medicinal Products for Human Use of the European Medicines Agency. The issuing of such opinions is usually followed within weeks by approval in the European Union (EU).
Pembrolizumab has already been approved as first-line treatment for this indication in the United States.
This makes pembrolizumab the first and so far only immunotherapy for first-line use in NSCLC. It is already approved for second-line use, as are two other immunotherapies – nivolumab (Opdivo, Bristol-Myers Squibb) and atezolizumab (Tecentriq, Genentech/Roche).
The positive opinion is based on data from the pivotal KEYNOTE-024 study, which showed significant improvements in both overall survival and progression-free survival with pembrolizumab when compared to chemotherapy in patients whose tumors expressed high levels of PD-L1 and did not have EGFR or ALK tumor mutations.
Results from this study, presented at the recent annual meeting of the European Society of Medical Oncology and
More recently, a new analysis from that study showed that pembrolizumab also improved quality of life in comparison with chemotherapy.
"Lung cancer is one of the leading causes of death in the EU, so today's news is an important step forward for many patients in Europe. If approved, patients with metastatic non–small cell lung cancer with high PD-L1 expression could receive pembrolizumab instead of chemotherapy," Merck said in a press release.
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