Tech Sheet: Gemcitabine API
Gemcitabine Hydrochloride is an analog of the antimetabolite nucleoside deoxycytidine with antineoplastic activity. Gemcitabine is converted intracellularly to the active metabolites difluorodeoxycytidine di-and triphosphate (dFdCDP and dFdCTP)
- dFdCDP - Inhibits ribonucleotide reductase, decreasing the deoxynucleotide pool available for DNA synthesis.
- dFdCTP - Incorporates into the DNA, resulting in DNA strand termination and apoptosis.
The timelines of USFDA approval of Gemcitabine Hydrochloride across indications are as follows:
- U.S. Food and Drug Administration (USFDA) approved Gemcitabine Hydrochloride to treat non-small cell lung cancer in 1998 and for treating metastatic cancer in 2004.
- The U.S. Food and Drug Administration (USFDA) has approved Gemzar® (Gemcitabine Hydrochloride), in combination with Taxol® (paclitaxel), providing a new option in first-line therapy for women battling metastatic breast cancer in 2004. In addition to the United States, Gemzar has been approved for metastatic breast cancer in 32 countries today.
- Gemzar is approved in more than 90 countries and is the worldwide standard of care for pancreatic cancer and non-small cell lung, bladder, and breast cancers in many parts of the world.
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