publication date: Mar. 15, 2019
Drugs & Targets
European Commission approves Keytruda + chemotherapy for NSCLC
European Commission has approved Keytruda in combination with carboplatin and either paclitaxel or nab-paclitaxel, for the first-line treatment of adults with metastatic squamous non-small cell lung cancer.
Keytruda is sponsored by Merck.
This approval is based on data from the phase III KEYNOTE-407 trial, which demonstrated that Keytruda in combination with chemotherapy significantly improved overall survival in adults with metastatic squamous NSCLC regardless of PD-L1 tumor expression status, reducing the risk of death by 36 percent compared to chemotherapy alone (HR=0.64 [95% CI, 0.49-0.85]; p=0.0008).
“In KEYNOTE-407, first-line treatment with Keytruda in combination with chemotherapy resulted in significant improvements in overall survival for patients with metastatic squamous non-small cell lung cancer, regardless of PD-L1 expression,” Luis Paz-Ares, chair of the medical oncology department, Hospital Universitario Doce de Octubre, Madrid, said in a statement. “Lung cancer is the leading cause of cancer death in Europe, so this approval marks an important milestone for the patients and families facing this difficult-to-treat type of lung cancer.”
The approval allows marketing of the Keytruda combination in all 28 EU member states plus Iceland, Lichtenstein and Norway, at the approved dose of 200 mg every three weeks until disease progression or unacceptable toxicity. In NSCLC, Keytruda is also approved in Europe for the:
First-line treatment of metastatic nonsquamous NSCLC in combination with pemetrexed and platinum chemotherapy in adults whose tumors have no EGFR or ALK positive mutations (KEYNOTE-189);
First-line treatment of metastatic squamous or nonsquamous NSCLC as monotherapy in adults whose tumors have high PD-L1 expression (tumor proportion score ≥50%) with no EGFR or ALK positive tumor mutations (KEYNOTE-024); and
Continue reading European Commission approves Keytruda + chemotherapy for NSCLC
To access this members-only content, please log in.
Institutional subscribers, please log in with your IP
If you're not a subscriber why not join today?
To gain access to the members only content click here
You will be given immediate access to premium content on the site.Click here to join.