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Abraxane on course for lung cancer indication in EU

CHMP backs news indication for Celgene drug
Celgene Abraxane pancreatic cancer

Celgene's cancer drug Abraxane is set to be available for people with lung cancer in the EU after a positive recommendation from the European Medicine Agency (EMA).

The agency's Committee for Medicinal Products for Human Use (CHMP) backed the use of the drug in the treatment of non-small cell lung cancer (NSCLC), expanding its indications, which already include breast cancer and pancreatic cancer.

The recommendation covers the use of Abraxane as a first-line treatment for patients with NSCLC who are not candidates for potentially curative surgery or radiation therapy.

Tuomo Patsi, president of Celgene in Europe, the Middle East and Africa (EMEA), commented: “The anticipated European Commission decision would be the third approved indication for Abraxane, underscoring the value of this medicine. We are committed to ensuing that patients who need Abraxane will gain access to it once approved by the European Commission.”

The opinion outcome was based on the results of a randomised, multi centre, open-label study that included 1,052 chemotherapy-naïve patients with stage IIIb/IV NSCLC.

The study compared Abraxane in combination with carboplatin against solvent-based paclitaxel with carboplatin. The overall response rate was significantly higher for patients who took Abraxane with carboplatin at 33%, compared to 25%.

The CHMP decision is a positive step for Abraxane after a challenging start to 2014. The drug was among a number to have an indication delisted from the Cancer Drugs Fund and it was rejected by NICE for pancreatic cancer over cost concerns.

Article by
Kirstie Pickering

27th January 2015

From: Sales



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