Saturday, February 9, 2013

Celgene wins U.S. regulatory approval for treating deadly blood cancer

Celgene Corp.’s therapy for a deadly blood cancer that will sicken more than 22,000 people in the U.S. this year won U.S. regulatory approval.
Pomalyst, or pomalidomide, was approved for multiple- myeloma patients who have tried and failed on at least two other drugs, including Celgene’s Revlimid and Takeda Pharmaceutical Co.’s Velcade, according to a statement today from the Food and Drug Administration. Pomalyst may generate sales of $1.1 billion in 2017 for Summit, New Jersey-based Celgene, according to the average of 12 analysts’ estimates compiled by Bloomberg.
Onyx Pharmaceuticals Inc., based in South San Francisco, California, makes a similar drug, Kyprolis, approved in July. Celgene’s FDA application for pomalidomide, like Kyprolis, was submitted under an accelerated approval program that allows a promising drug to treat a serious disease on the market before final clinical trials are complete.
“Treatment for multiple myeloma is tailored to meet individual patient’s needs, and today’s approval provides an additional treatment option for patients who have not responded to other drugs,” Richard Pazdur, director of the FDA’s Office of Hematology and Oncology Products, said in the statement.
Pomalyst will carry a boxed warning that the product can cause blood clots and that pregnant women shouldn’t use the drug because it can lead to life-threatening birth defects. Women of childbearing age who take the treatment must comply with pregnancy testing and both males and females have to adhere to contraception requirements, the FDA said.
Revlimid Sales
Pomalyst will only be available through prescribers and pharmacies that are trained to dispense the medicine. Revlimid has similar requirements.
Revlimid, a multiple myeloma drug patients can take after trying one previous therapy, is Celgene’s top seller with $3.8 billion in sales last year, according to data compiled by Bloomberg.
Multiple myeloma is a cancer of the plasma cells, which are white blood cells that make antibodies that help protect the body from germs, according to the National Institutes of Health.
As many as 15,000 patients each year in the U.S. fail Revlimid and Osaka, Japan-based Takeda’s Velcade, Gene Mack, an analyst with Brean Capital in New York, said in a phone interview. At least 60 percent of those patients are eligible for Kyprolis and Pomalyst, he said.
Patients who use Onyx’s Kyprolis may move to Celgene’s Pomalyst and vice versa, or they may get both drugs in combination, Michael Yee, an analyst with RBC Capital Markets in San Francisco, said by phone.
Celgene found patients taking pomalidomide orally plus a low dose of the steroid dexamethasone lived a median 3.6 months without their disease worsening, compared to 1.8 months for patients taking a high dose of the steroid alone, according to a final-phase study the company presented at the American Society of Hematology meeting in Atlanta in December.

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