Nanotechnology Breast Cancer Drug Under Scanner

Abraxane, the nanotechnology breast cancer drug, developed by Abraxis BioScience, Inc, is widely advertised in the United States under a co-endorsement agreement between Abraxis and AstraZeneca Pharmaceuticals LP. According to the agreement signed with the US based company, Biocon has rights to sell Abraxane in India, Pakistan, UAE, Saudi Arabia, Kuwait and some South Asian and Persian Gulf countries. In 2005, the U.S. FDA approved the use of Abraxane in Injectable Suspension for breast cancer treatment taking into consideration its side effects, post the not so desirable effects of chemotherapy.

However, when Natco Pharma’s Albupax , the cancer remedy did not pass the vital safety trials, the Drug controller general of India (DGCI), that is India’s drug regulator has instructed a fresh rounds of tests to be carried on Abraxane, the medicine’s original version.

The new rounds of tests are on way as a safety measure subsequent to Natco’s drug that showed high endotoxin levels that has a potential to cause massive disorder in cancer inflicted.

The series of tests being carried out on Abraxane include tests on analogous parameters of endotoxin and chloroform levels that were conducted on Natco’s Albupax Drug. Albupax has reported elevated levels of endotoxin, considered higher than normal, with the outcome of the chloroform tests expected soon. Due to this outcome, Natco has revoked the drug from the market, but has repeatedly stated that its product clears all quality standards.

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