Paclitaxel

CAS 33069-62-4

About the API

Therapeutic category Oncology
Available formulations Injectables
Regulations CEP Flag CEP EU DMF Flag EU DMF US DMF Flag US DMF

General Information

Derived from the Pacific yew tree, paclitaxel has therapeutic potential for a variety of cancers, including ovarian cancer, breast cancer, non-small cell lung cancer and AIDS-related Kaposi sarcoma (a type of cancer that develops under the skin). It is administered intravenously. Specific uses for paclitaxel: 1. First-line and subsequent therapy for the treatment of advanced ovarian cancer.

 

As first- line therapy, it is used in combination with cisplatin. 2. Treatment of node-positive breast cancer (after primary therapy, which usually includes surgery), along with standard doxorubicin-containing combination chemotherapy. 3. Treatment of breast cancer after failure of combination chemotherapy for metastatic disease or relapse within six months of adjuvant chemotherapy.

 

Prior therapy should have included an anthracycline unless clinically contraindicated. 4. First-line treatment, in combination with cisplatin, of non-small cell lung cancer in patients who are not candidates for potentially curative surgery and/or radiation therapy. 5. Second-line treatment of AIDS-related Kaposi’s sarcoma. Paclitaxel has also been approved for treatment of pancreatic cancer in the UK and has been included in treatment regimens for melanoma.

 

Paclitaxel was approved by the FDA in 1992 under the trade name Taxol. It is produced through semi-synthesis, i.e., a chemical process that makes use of compounds derived from natural sources as starting material. It may also be produced through fermentation. Paclitaxel injectable is manufactured with ingredients that allow the medication to reach parts of the body where it is needed.

 

One form is manufactured with human albumin (to treat breast cancer that has not improved or relapse after treatment with other medications), and the other form is manufactured with a solvent called polyoxyethylated castor oil (to treat ovarian cancer, breast cancer, lung cancer and AIDS-related Kaposi’s sarcoma).