FDA Gives New Indication for Paclitaxel

FDA Gives New Indication for Paclitaxel

FDA Approved Sep 2013 Paclitaxel 33069-62-4On September 6, 2013 the FDA approved a new indication for the formidable pancreatic cancer drug Paclitaxel. Known as the brand name Abraxane, which is marketed by Celgene, Paclitaxel is now officially indicated for the first-line treatment of patients with metastatic pancreatic cancer. Paclitaxel will be used in a combination treatment, alongside Gemcitabine, to treat unresectable adenocarcinoma of the pancreas. This news comes as a promise of new hope for the roughly 45,000 American patients who are diagnosed with this virulent disease each year. Of the patients diagnosed, a little over 38,000 of these people will not survive. With such grim statistics the advent of this new indication for Paclitaxel is especially encouraging, particularly for these patients who are at the end stages of pancreatic cancer.

pancreatic cancer survival and stage

As the fourth leading cause of cancer deaths, incurable pancreatic cancer has taken the lives of many Americans, most notably Apple guru Steve Jobs. Studies offered hopeful data for the patient population suffering from metastatic pancreatic cancer. With the average time given to patients with advanced pancreatic cancer being less than six months to live, a main clinical trial of Paclitaxel indicated significantly better statistics. Of the patients who received both Paclitaxel and Gemcitabine in the main clinical trial they lived an average of eight and a half months. Compared to a little over six and a half months of life for the patients who were administered Gemcitabine only, these extra two months were undoubtedly a gift for these patients.

albumin-bound-paclitaxelPaclitaxel is believed to work by binding in tiny particles to the human protein albumin. This bond subsequently enhances the delivery of Paclitaxel to the tumor site, which also reduces prolonged adverse effects. There are side effects from treatment with Paclitaxel, however, and these may include a slight risk of a severe bacterial bloodstream infection or inflammation of the lung. Typical side effects include hair loss, exhaustion, joint pain and neuropathy. Researchers and the medical community are enthusiastic about this new indication for Paclitaxel, which is already approved to treat both breast and non-small cell lung cancer. Despite the small risk for adverse reactions, Paclitaxel remains a worthy opponent for treating patients with unresectable pancreatic cancer, and it is looking like it may be the next standard of care treatment for metastatic pancreatic cancer as well.

LGM Pharma is a supplier of Paclitaxel CAS# 33069-62-4 for research and development purposes, as well as the exclusive distributor of Teva’s Paclitaxel API for the U.S. pharmacy compounding market. Clients can be assured of continuous support throughout the R&D process, as well as quality API products.


Products currently covered by valid US Patents are offered for R&D use in accordance with 35 USC 271(e)+A13(1). Any patent infringement and resulting liability is solely at buyer risk.


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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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