By Ben Fox Rubin
Celgene Corp. (CELG) received a positive opinion for its
pancreatic-cancer treatment Abraxane from the European Medicines
Agency's Committee for Medicinal Products for Human Use, paving the
way for potential approval of the treatment.
The CHMP reviews applications for all 28 member states in the
European Union, as well as Norway and Iceland. The European
Commission, which generally follows the recommendation of the CHMP,
is expected to make its final decision within two to three months,
Celgene said.
The positive opinion was for the use of Abraxane in combination
with gemcitabine for first-line treatment of adult patients with
metastatic adenocarcinoma of the pancreas. Pancreatic cancer is
currently the fourth most common cause of cancer death in the
EU.
Celgene said there has been no new treatments approved for
pancreatic cancer in nearly seven years.
"The positive CHMP opinion on Abraxane with gemcitabine for
metastatic pancreatic cancer is a significant step toward bringing
the first new treatment option in many years to people diagnosed
with this deadly disease, " said Alan Colowick, president of
Celgene Europe, the Middle East and Africa.
He added the drug combination has demonstrated "statistically
significant and clinically meaningful improvements" in overall
survival compared to gemcitabine alone.
The U.S. Food and Drug Administration in September approved
Celgene's supplemental new drug application for the use of Abraxane
with gemcitabine for pancreatic cancer treatment.
Shares closed Thursday at $158.61 and were inactive premarket.
The stock has more than doubled this year.
Write to Ben Fox Rubin at ben.rubin@wsj.com
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