GSK: 'breakthrough drug' status for colon cancer

(CercleFinance.com) - GSK announced on Monday that its Jemperli antibody had received breakthrough therapy designation from the US FDA for the treatment of 'dMMR MSI-H' colorectal cancer.


The British company said the designation was prompted by the 'unprecedented' results of a Phase III study, which showed that 100% of the 42 patients enrolled in the trial achieved a response rate.

In the US, Innovative Drug Designation is intended to accelerate the development and review of drugs for the treatment of serious or life-threatening diseases.

Colorectal cancers known as 'dMMR/MSI' are tumors characterized by genetic instability in the tumor cells, related to a defect in DNA mismatch repair.

GSK also announced that the European Medicines Agency (EMA) had granted Priority Medicinal Product (PRIME) status to its antibody conjugate GSK5764227 in the treatment of extended-stage small cell lung cancer.


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