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Celgene Has Received Approval From The US Food and Drug Administration

Celgene has received approval from the US Food and Drug Administration (FDA) for its drug 'Abraxane' to treat patients with late-stage adenocarcinoma of the pancreas.

Adenocarcinoma is a sub-type of exocrine tumors which accounts for about 95% of cancers of the pancreas.

According to Celgene, the drug's trials have shown that patients with pancreatic cancer had higher survival rate when they were treated with Abraxane.

Abraxane, a chemotherapy drug that can slow the growth of certain tumors, is intended to be used in combination with another chemotherapy drug called gemcitabine, in patients with pancreatic cancer that has spread to other parts of the body.

Celgene executive vice president of hematology and oncology Jean-Pierre Bizzari said, "The addition of ABRAXANE to gemcitabine demonstrated meaningful improvements across key efficacy outcomes, including overall survival, with a well-characterized safety profile."

The metastatic pancreatic adenocarcinoma clinical trial (MPACT) study, a Celgene-sponsored, open-label, randomised, international study, was one of four studies to show an overall survival benefit.

While the primary endpoint for the study was overall survival, secondary endpoints were progression-free survival and overall response rate determined by independent radiological review.

Under the MPACT study, around 861 patients with metastatic pancreatic cancer were treated with Abraxane plus gemcitabine which showed a significant improvement in median overall survival compared to gemcitabine alone.

According to the MPACT study, patients treated with Abraxane plus gemcitabine lived, on average, 1.8 months longer than those treated with gemcitabine alone.

Source: http://regulatoryaffairs.pharmaceutical-business-review.com/news/us-fda-approves-celgenes-abraxane-for-pancreatic-cancer-090913
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US FDA Approves Celgene's Abraxane for Pancreatic Cancer