Celgene grabs FDA approval for new multiple myeloma pill

The FDA approved Celgene's Pomalyst for multiple myeloma.--Courtesy of Celgene

The FDA stamped an approval on Celgene's Pomalyst, a new oral treatment in a growing armament of meds against the blood cancer known as multiple myeloma. And the market green light gives company ($CELG) CEO Bob Hugin one of the key pieces to his plan for rapid business growth over the next several years.

The agency green-lighted Pomalyst, or pomalidomide, for combating cases of multiple myeloma that have persisted after two or more prior therapies. Approval was based on a 221-patient clinical trial, in which 7.4% of patients on Pomalyst alone had their multiple myeloma at least partially wiped out. The results were promising enough for Celgene to secure a relatively quick nod from the agency to market the drug while further study confirms its safety and efficacy.

Hugin is counting on the addition of Pomalyst as part of his plan to double sales at Celgene to $12 billion by 2017. The drug joins a growing portfolio of cancer meds from the company, including the flagship product Revlimid and the blockbuster hopeful Abraxane. Later this year Celgene aims to file for approval of its experimental drug apremilast for psoriasis, an autoimmune disease, giving the company multiple new products to pave the way to Hugin's big revenue goal.

The FDA has now approved two new meds for multiple myeloma over the past year, with the agency's nod in July for Onyx Pharmaceuticals' ($ONXX) Kyprolis (carfilzomib). Pomalyst will cost $10,500 monthly, just a bit more expensive than Kyprolis, currently priced at $9,950 per month, according to a investor note from J.P. Morgan analyst Cory Kasimov on Friday.

"Pomalyst is the third drug in a class of immunomodulatory agents that includes lenalidomide and thalidomide," said Dr. Richard Pazdur, director of the Office of Hematology and Oncology Products in FDA's Center for Drug Evaluation and Research, in a statement. "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."

With an estimated 21,700 diagnoses and 10,710 deaths from multiple myeloma annually, the disease afflicts mostly older adults. Yet the FDA is warning doctors against using the drug for pregnant mothers with what the industry calls a "Boxed Warning" because the treatment could cause birth defects.

- here's the FDA's release
- see the article from Dow Jones Newswires

Suggested Articles

Solid Bio fixed the manufacturing issue that led to a partial clinical hold on its DMD trial, but a full hold remains.

Commissioner Scott Gottlieb has laid out the reasons why he thinks the FDA needs a double-digit budget bump.

GW's cannabis-based epilepsy drug scored a favorable review from FDA staff ahead of an expert panel meeting.