Celgene Corp said a late-stage trial of its cancer drug Revlimid met the main goal of improving survival in newly diagnosed blood cancer patients, potentially opening up the path for a wider use of the drug.
The company's shares were up 7 percent at $133.07 in morning trade. Analysts said the data was largely expected and will also pave the way for a European approval application for the drug.
Celgene had withdrawn the European marketing application for a wider use of the drug in June 2012, after regulators asked for more data.
"We note that this news removes a key overhang for Celgene as with these data, they can now file for approval in the EU ... (The) EU filing may come by end of the year," Deutsche Bank Analyst Robyn Karnauskas wrote in a note.
Celgene said it will start discussions with regulators and plans to submit applications in the United States, Europe and other markets.
Regulatory decision from United States and European agencies are expected in 2015, analysts said.
Revlimid is Celgene's flagship blood cancer drug and is already approved for use in multiple myeloma patients who have failed at least one prior therapy, mantle cell lymphoma and transfusion-dependent anemia caused by myelodysplastic syndromes - a blood disorder.
The late-stage study tested the oral drug in patients with newly diagnosed multiple myeloma, and showed a statistically significant improvement in survival without the cancer worsening.
The evaluation of safety and efficacy was ongoing and the results will be presented at an upcoming medical meeting, Celgene said.
Deutsche Bank's Karnauskas said that while the magnitude of benefit with continuous Revlimid usage was not disclosed, she expected progression-free survival in the group to be 35-36 months.
"Notably, we expect control arm to do 25-26 months in this study," she said.
Multiple myeloma is the second most commonly diagnosed blood cancer. It starts in the plasma cells in the bone marrow and ultimately disrupts the production of normal blood cells.
The American Cancer Society estimates there will be about 22,350 new cases diagnosed in 2013 and about 10,710 deaths.
Revlimid, Celgene's most important growth driver, brought in sales of about $1 billion during the first quarter.
The approval for mantle cell lymphoma came in early last month.
According Thomson Reuters Pharma, Revlimid annual sales are expected to reach $4.2 billion in 2013 and $5.37 billion in 2015.
Source : courant.comThe company's shares were up 7 percent at $133.07 in morning trade. Analysts said the data was largely expected and will also pave the way for a European approval application for the drug.
Celgene had withdrawn the European marketing application for a wider use of the drug in June 2012, after regulators asked for more data.
"We note that this news removes a key overhang for Celgene as with these data, they can now file for approval in the EU ... (The) EU filing may come by end of the year," Deutsche Bank Analyst Robyn Karnauskas wrote in a note.
Celgene said it will start discussions with regulators and plans to submit applications in the United States, Europe and other markets.
Regulatory decision from United States and European agencies are expected in 2015, analysts said.
Revlimid is Celgene's flagship blood cancer drug and is already approved for use in multiple myeloma patients who have failed at least one prior therapy, mantle cell lymphoma and transfusion-dependent anemia caused by myelodysplastic syndromes - a blood disorder.
The late-stage study tested the oral drug in patients with newly diagnosed multiple myeloma, and showed a statistically significant improvement in survival without the cancer worsening.
The evaluation of safety and efficacy was ongoing and the results will be presented at an upcoming medical meeting, Celgene said.
Deutsche Bank's Karnauskas said that while the magnitude of benefit with continuous Revlimid usage was not disclosed, she expected progression-free survival in the group to be 35-36 months.
"Notably, we expect control arm to do 25-26 months in this study," she said.
Multiple myeloma is the second most commonly diagnosed blood cancer. It starts in the plasma cells in the bone marrow and ultimately disrupts the production of normal blood cells.
The American Cancer Society estimates there will be about 22,350 new cases diagnosed in 2013 and about 10,710 deaths.
Revlimid, Celgene's most important growth driver, brought in sales of about $1 billion during the first quarter.
The approval for mantle cell lymphoma came in early last month.
According Thomson Reuters Pharma, Revlimid annual sales are expected to reach $4.2 billion in 2013 and $5.37 billion in 2015.
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