FDA clears drug to help harvest stem cells to treat multiple myeloma patients

The injectable will be sold by an Israeli biotech BioLineRx, which has its US headquarters in Waltham

On Monday, the FDA approved BioLineRx's new drug, Aphexda, which helps doctors collect stem cells to treat patients with multiple myeloma.Jacquelyn Martin/Associated Press

BioLineRx, an Israeli biotech that set up US operations in Waltham last year, said Monday that it has won federal approval to sell a new drug that helps doctors collect stem cells to treat patients with multiple myeloma, the second most common form of blood cancer.

Food and Drug Administration officials cleared Aphexda, which stimulates the release of more stem cells into the blood of patients who need bone marrow transplants, also known as stem cell transplants.

The transplants replace defective blood-forming cells with healthy ones in multiple myeloma patients. They are done to delay relapse after patients have already been treated with other drugs to bring their blood cancer into remission.

Aphexda, which is delivered with an injection under the skin, helps doctors and technicians collect more of the healthy stem cells from patients’ bone marrow in a shorter time.

The injectable will be used in combination with another drug called Filgrastim, which is already used to flush stem cells into the blood of multiple myeloma patients during harvesting sessions at transplant centers. The California biotech firm Amgen makes Filgrastim.

About 8,000 patients in the US have stem cell transplants each year.

“The idea here is to mobilize more cells than the current treatments allow, and to allow it to be done in a minimum amount of [collection] sessions,” said BioLineRx chief executive Phil Serlin, who is based at the company’s headquarters in Modi’in, Israel, outside Tel Aviv.

In a clinical trial that used Aphexda along with Filgrastim, researchers were able to collect enough stem cells in a single day for about 90 percent of multiple myeloma patients undergoing bone marrow transplants. The cell mobilization can currently take as many as five days, depending on the age and health of the patient.

BioLineRx, a 20-year-old company that initially worked on treatments for skin lesions, pivoted in recent years to developing drugs that aid in harvesting of stem cells. Last year, it opened its US headquarters in Waltham and named Holly May, a veteran of the Genzyme rare disease business, to lead operations here.

The company now has 43 employees in Waltham and about 45 in Israel.

More than a dozen smaller biotechs in Israel and across Europe have set up US operations in the Boston area to gain access to skilled scientists and researchers while tapping the large US market for medicines.

“The biotech mecca in the United States is Boston,” said May, president of BioLineRx USA, who joined the company last fall. “We’re able to attract really great talent by locating our headquarters here.”

FDA’s clearance of Aphexda is the drug’s first regulatory approval anywhere in the world, but BioLineRx will also seek to launch it in other countries.

BioLineRx is also developing other therapies for cancers and rare diseases, including pancreatic cancer and sickle cell disease.