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Ministry grants additional indication to MSD’s immunotherapeutic drug
  • By Lee Han-soo
  • Published 2019.05.21 14:55
  • Updated 2019.05.21 14:55
  • comments 0

Keytruda, immunotherapy from MSD, has obtained additional approval from the Ministry of Food and Drug Safety as a first-line combination treatment with chemotherapy for metastatic squamous cell lung cancer.

MSD Korea’s immunotherapy Keytruda

Cytotoxic chemotherapy had so far been the only standard therapy for patients with metastatic squamous cell lung cancer without epidermal growth factor receptor (EGFR) mutations and anaplastic large-cell lymphoma kinase (ALK) mutations.

The granting of the additional indications on Monday, however, gave new option to receive immunotherapy to patients with metastatic squamous cell lung cancer without EGFR or ALK mutations. The approval has also made Keytruda the first and only immunotherapeutic agent available for all metastatic non-small cell lung cancer (NSCLC) patients as mono- and combination- therapy available.

The ministry based the approval on MSD’s most recent KEYNOTE-407 study.

A total of 559 patients with metastatic squamous cell lung cancer without EGFR or ALK gene mutation, regardless of PD-L1 expression level, participated in the research. The results of the study showed that the combination of Keytruda and chemotherapy significantly improved overall survival (OS) and progression-free survival (PFS) compared to chemotherapy.

The median OS was 15.9 months in Keytruda combo group and 11.3 months in the chemotherapy group, and the two groups had a median PFS of 6.4 months and 4.8 months, respectively.

“The latest approval is meaningful in that it offers Keytruda as a first-line treatment option for all patients with metastatic NSCLC,” said Choi Jae-yeon, executive director of MSD Korea's oncology franchise. "We hope that patients with advanced NSCLC will benefit from scientifically proven innovative drugs as a first treatment.”


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