publication date: Dec. 16, 2016
Drugs & Targets
Keytruda becomes first anti-PD-1 therapy to receive a CHMP positive opinion for previously untreated NSCLC
MERCK announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency adopted a positive opinion recommending approval of Keytruda (pembrolizumab) for the first-line treatment of metastatic non-small cell lung cancer in adults whose tumors have high PD-L1 expression (tumor proportion score [TPS] of 50 percent or more) with no EGFR or ALK positive tumor mutations.
The recommendation will now be reviewed by the European Commission for marketing authorization in the European Union. A final decision is expected in the first quarter of 2017.
Keytruda is approved in Europe for the second-line treatment of patients with locally advanced or metastatic NSCLC whose tumors express PD-L1 and who have received at least one prior chemotherapy regimen. Patients with EGFR or ALK positive tumor mutations should also have received targeted therapy before receiving Keytruda.
The positive opinion is based on data from KEYNOTE-024, a pivotal study which demonstrated superior overall survival and progression-free survival with Keytruda compared to chemotherapy in patients whose tumors expressed high levels of PD-L1 with no EGFR or ALK positive tumor mutations.
KEYNOTE-024 is a randomized, open-label, phase 3 study evaluating KEYTRUDA monotherapy at a fixed dose of 200 mg compared to standard of care platinum-containing chemotherapy for the treatment of patients with both squamous and non-squamous metastatic NSCLC.
The study enrolled patients who had not received prior systemic chemotherapy treatment for their metastatic disease and whose tumors had high PD-L1 expression with no EGFR or ALK aberrations.
In the US, Keytruda is approved for indications that include melanoma, lung cancer, and head and neck cancer.
NINTEDANIB … Continue reading Keytruda becomes first anti-PD-1 therapy to receive a CHMP positive opinion for previously untreated NSCLC
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