Gemcitabine 1st Approval In South Africa

23 January 1995

Eli Lilly's Gemstar (gemcitabine) anticancer drug has received its first approval in South Africa as a single-agent therapy for the treatment of locally advanced or metastatic non-small cell lung cancer.

Gemcitabine is an inhibitory alternative substrate for ribonucleotide reductase, the enzyme which is central to the production of deoxynucleotides required during DNA synthesis and repair. The drug produces an effect known as masked chain termination, which prevents DNA polymerization. The cell death associated with this effect has the morphological and biological characteristics of programmed cell death.

The registration of the drug was based on two Phase II trials, conducted in South Africa and Europe.

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