Is Capecitabine the Next Generic Blockbuster of Chemotherapy Drugs?

Is Capecitabine the Next Generic Blockbuster of Chemotherapy Drugs?

Regarded as a blockbuster drug used to treat both metastatic breast and colorectal cancer, Capecitabine is also known by the trade name Xeloda, which is marketed by Roche Pharamaceuticals. Capecitabine, CAS# 154361-50-9, is waiting in the wings to become a generic boon in the pharmaceutical industry, as the patent for Xeloda meets an expiration in December of 2013. The expiration of the ‘949 patent on December 14, 2013 is projected to successfully lead to the roll out of additional patents for this formidable drug through 2015. As the the first oral chemotherapy drug approved in the United States for breast and colorectal cancer, as well as Dukes’ C Stage III colon cancer, capecitabine is an effective chemotherapeutic agent. Offered in 150 and 500 milligram tablets, capecitabine is efficacious as an antimetabolite, and  it works by stopping or slowing the growth of cancer cells. Typically prescribed twice daily, to be taken in the morning and in the evening, capecitabine is commonly taken for two weeks and  followed with a one week break. The dosage cycle may or may not be repeated, depending on patient specifications for treatment. It is best to take capecitabine with a full glass of water, and after a meal. Adverse effects include stomach pain, constipation, increased thirst, loss of appetite, exhaustion, weakness, hair loss, dizziness and skin rash.


Researchers concerned with the use of capecitabine as an adjunct alongside other chemotherapeutic agents are currently exploring these prospects. Thus far positive information has been gleaned by researchers who have studied capecitabine and temsirolimus, CAS# 162635-04-3. Georgetown University Medical Center  released initial results from Phase I trial which examined the use of both temsirolimus and capecitabine to treat patients with advanced malignancies. The phase 1 results were published May 16, 2012 and indicated promising evidence to continue to Phase 2 trials after the presentation of the results at the American Society of Clinical Oncology (ASCO) annual meeting in Chicago in June 2012. In addition, researchers published study results in the American Journal of Clinical Oncology on May 22, 2012 indicated a positive response to the combination of thalidomide and capecitabine. This combination was successfully given to patients with advanced hepatocellular carcinoma, and indicated a positive pathological response rate for this patient population. Participants were dosed with 2000 milligrams of capecitabine for 14 days, every 3 weeks, as well as an oral dose of thalidomide ranging from 50 to 200 milligrams. The median survival rate for patients in this study was 5.1 months.

LGM also offers capecitabine as a TEVA API (TAPI) product for compounding purposes in the U.S., and strives to meet the total needs of clients throughout the research and development process.


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LGM Pharma Acquires CDMO

On July 27, 2020, LGM Pharma announced its acquisition of the formulation development and drug product contract manufacturing business of Nexgen Pharma, Inc. As a result, you will notice our new logo and visuals throughout the website. We’re working on updates to reflect the exciting, expanded CDMO capabilities and services we now can offer you.

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