EMA Recommends Celgene’s Nano Cancer Drug

Celgene International Sàrl, a wholly owned subsidiary of Celgene Corporation, reports that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for Abraxane (paclitaxel formulated as albumin-bound nanoparticles, or nab-paclitaxel) in combination with carboplatin for the first-line treatment of non-small cell lung cancer (NSCLC) in adult patients who are not candidates for potentially curative surgery and/or radiation therapy. Abraxane is an albumin-bound form of paclitaxel that is manufactured using patented nab technology. Abraxanee is formulated with albumin, a human protein.

The CHMP reviews applications for all 28 member states in the European Union (EU), as well as Norway, Liechtenstein, and Iceland. The European Commission, which generally follows the recommendation of the CHMP, is expected to make its final decision within approximately two months. If approval is granted, detailed conditions for the use of this product will be described in the Summary of Product Characteristics, which will be published in the revised European Public Assessment Report (EPAR).

Abraxane was first approved in January 2005 by the US Food and Drug Administration (FDA) for the 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. In Europe, Abraxane was approved in January 2008 as a monotherapy for the treatment of metastatic breast cancer in adult patients who have failed first-line treatment for metastatic disease and for whom standard, anthracycline containing therapy is not indicated. The drug is now approved in more than 50 countries for the treatment of metastatic breast cancer.

In 2013, the drug was approved by the FDA for the first-line treatment of locally advanced or metastatic NSCLC in combination with carboplatin, in patients who are not candidates for curative surgery or radiation therapy. The drug is also approved for the treatment of NSCLC in Argentina, Australia, Chile, Ecuador, Guatemala, Hong Kong, Japan, New Zealand, and Singapore. In 2013, the drug was approved in the US and the EU for treating metastatic pancreatic cancer.

Source: Celgene

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