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MSD Korea’s Keytruda wins 2 new indications for treating cancer
  • By Shim Hyun-tai
  • Published 2020.08.31 16:44
  • Updated 2020.08.31 16:44
  • comments 0

MSD Korea’s immunotherapy Keytruda (ingredient: pembrolizumab) obtained two more approvals from the Ministry of Food and Drug Safety on Aug. 27.

It won approval to treat cancer patients with microsatellite instability-high (MSI-h) or mismatch repair (MMR) biomarker and Bacillus Calmette-Guerin-refractory, high risk, and non-muscle invasive bladder cancer (NMIBC).

MSD Korea’s anticancer therapy Keytruda won approval for two more indications from the Ministry of Food and Drug Safety on Aug. 27. (MSD)

MSI-h refers to a state with an abnormal length of deoxyribonucleic acid (DNA) base sequence caused by deficient MMR, a genome that repairs errors during DNA replication.

The U.S. Food and Drug Administration allowed using Keytruda to treat cancer patients with MSI-h or deficient MMR in May 2017, awarding the first biomarker-based indication for treating any cancer in the world.

The Korean regulators also approved Keytruda as a treatment for high risk BCG-refractory NMBIC patients with intraepithelial carcinoma who could not or have not received cystectomy.

Treating NMBIC patients is based on transurethral cystectomy. However, those who accompany intraepithelial carcinoma have to consider radical cystectomy if they do not respond to the drug administered to the bladder. With the recent expansion of Keytruda’s indication, patients got another option to receive therapy without removing the bladder.

“The approval is significant as we can provide a new therapeutic option to patients with various cancer types at the same time by applying common genetic mutations in cancer to multiple treatments,” said Kim Soo-jung, MSD Korea’s medical department executive director. “MSD is continuing to research the development of innovative anticancer therapy based on the molecular genetic understanding of cancer cells.”

shim531@docdocdoc.co.kr

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