Genzyme nabs FDA approval for stem cell mobilizing agent

Publication
Article
Oncology NEWS InternationalOncology NEWS International Vol 18 No 2
Volume 18
Issue 2

Genzyme has won a nod from the FDA to market Mozobil (plerixafor) in the U.S. The drug is intended to be used in combination with granulocyte-colony stimulating factor to mobilize hematopoietic stem cells to the bloodstream for collection and subsequent autologous transplantation in patients with non-Hodgkin’s lymphoma and multiple myeloma. The product has also been granted orphan drug designation by the FDA.

Genzyme has won a nod from the FDA to market Mozobil (plerixafor) in the U.S. The drug is intended to be used in combination with granulocyte-colony stimulating factor to mobilize hematopoietic stem cells to the bloodstream for collection and subsequent autologous transplantation in patients with non-Hodgkin’s lymphoma and multiple myeloma. The product has also been granted orphan drug designation by the FDA.

Mozobil, a small-molecule CXCR4 chemokine receptor antagonist, is designed to mobilize hematopoietic stem cells from the bone marrow into the bloodstream where they can be collected, making it more likely for eligible patients to proceed to transplant.

In studies, 59% of NHL patients who received Mozobil and G-CSF collected the target number of at least five million stems cells/kg of body weight in four or fewer apheresis sessions, compared with 20% for placebo. The median number of days to reach the target cell count was three Mozobil and not evaluable in the placebo group.

Seventy-two percent of patients with multiple myeloma who received Mozobil and G-CSF collected the target number of at least six million stem cells/kg of body weight in two or fewer apheresis sessions, compared with 34% of placebo patients. The median number of days to reach the target cell count was one day for the Mozobil group.

Recent Videos
“Every patient [with multiple myeloma] should be offered CAR T before they’re offered a bispecific, with some rare exceptions,” said Barry Paul, MD.
Barry Paul, MD, listed cilta-cel, anito-cel, and arlo-cel as 3 of the CAR T-cell therapies with the most promising efficacy in patients with multiple myeloma.
Elucidating nonresponses to bispecific T-cell engagers may be an important research consideration in the multiple myeloma field.
Fixed treatment durations with bispecific antibodies followed by observation may help in mitigating infection-related AEs, according to Shebli Atrash, MD.
Shebli Atrash, MD, stated that MRD should be considered carefully as an end point, given potential recurrence despite MRD negativity.
The National ICE-T Conference may inspire future collaboration between community and academic oncologists in the management of different cancers.
Long-term toxicities like infections and secondary primary malignancies remain a concern when sequencing novel agents for those with multiple myeloma.
Management of adverse effects and access to cellular therapies among community oncologists represented key points of discussion in multiple myeloma.
“If you have a [patient in the] fourth or fifth line, [JNJ-5322] could be a valid drug of choice,” said Rakesh Popat, BSc, MBBS, MRCP, FRCPath, PhD.
Earlier treatment with daratumumab may be better tolerated for patients with pretreated MRD-negative multiple myeloma.
Related Content