Celgene Wins FDA Approval of Third Myeloma Drug

2/8/13Follow @xconomy

Celgene has diversified its lineup of drugs once again, winning FDA approval today to start selling its third product for multiple myeloma in the U.S.

Summit, NJ-based Celgene (NASDAQ: CELG) said today it has gotten FDA clearance to start selling pomalidomide (Pomalyst) for patients whose disease has gotten worse after two prior rounds of treatment for multiple myeloma. The drug is a chemical modification of Celgene’s original hit for multiple myeloma, thalidomide, as is the company’s other myeloma drug—lenalidomide (Revlimid).

The new Celgene drug is supposed to be able to treat patients whose disease is spreading after they got treatment with Millennium: Takeda’s bortezomib (Velcade) and Celgene’s lenalidomide (Revlimid). A clinical trial of 221 patients with that grim prognosis showed the new Celgene drug, in combo with a low dose of the immune-suppressor dexamethasone, was able to partially or completely shrink tumors for about 29.2 percent of patients and keep their disease in check for a median time of 7.4 months, according to an FDA statement. Some of the drug’s common side effects include a decrease in infection-fighting white blood cells, fatigue and weakness, constipation, and diarrhea, the FDA said.

The Celgene product will now be in a position to compete with Onyx Pharmaceuticals’ carfilzomib (Kyprolis), which the FDA approved in July. It will also help diversify Celgene, which leans heavily on its lenalidomide franchise. The older drug generated about $3.8 billion in sales last year, or about 68 percent of Celgene’s total of $5.5 billion in sales. About 21,700 people in the U.S. are diagnosed with multiple myeloma each year and 10,710 die every year from the disease, the FDA said.

“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,” said Richard Pazdur, the director of the FDA’s cancer drug review office, in a statement.

Celgene set the price of the drug at $10,455 per monthly treatment cycle and patients are expected to get about five cycles in a course of therapy, according to a spokeswoman. Onyx set its price for carfilzomib at $9,950 a month, which was about a 10 percent premium on a per vial basis over Millennium: Takeda’s bortezomib, Onyx has said. Celgene’s drug has a different way of working, as it spurs the immune system to fight cancer cells, while Onyx and Millennium’s drugs work to inhibit proteasomes in the cell.

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  • Argo

    carfilzomib launched first and will soon be used in front line despite its indication. The better safety profile over Velcade makes it a hit with HCP’s (no peripheral neuropathy). Pomalidamide is no better than Revlimid. HCP’s will probably use Revlimid plus carfilzomib. all other celgene drugs have been dudes: Abraxane has not been growing- the only shot it has is in Pancreatic cancer. The Lung indication in non-inferiority to generic taxol. Maybe istodax will save the day ! even there that drug as competition from Seattle Genetics. Derms wont prescribe aprymelast as much as Celgene would like to think. Even WS says that they priced it too high. Not sure about old faithful anymore.