Omisirge (omidubicel) is the first allogeneic (from a donor) product for SCT that has been the recipient of FDA approval. The FDA’s nod moves Omisirge into the realm of the standard of care for patients who struggle to locate an appropriately matched donor.
Note that autologous, as opposed to allogeneic, refers to using a patient’s own cells for a stem cell transplant or for cell therapy.
Allogeneic SCT has been used often in hematological malignancies such as acute myeloid leukemia, myelodysplastic syndromes, acute lymphoblastic leukemia, and to a lesser extent, chronic myeloid leukemia.
This approval meets an urgent unmet need when a patient is unable to locate a matched donor under an autologous SCT process using the patient’s own cells.
The Phase III trial confirmed the superiority of Omisirge to cord blood in such areas as:
- Engraftment – when the body accepts the SCT (12 days vs. 22 days)
- Bacterial or fungal infections (39% vs. 60%)
- Platelet recovery – (55% vs. 35%)
- Initial 100 days where the patient has time out of the hospital (61 vs 48)
SCT provides eligible patients with a possible cure, but it comes with a risk. Success depends on the cells being well-matched. Donor cells from someone related to the patient offer a lower risk. Patients without a related donor may consult the stem cell donor registry for a match.
There is a caveat regarding the lack of diversity in the donor registries. Non-Caucasian patients will have difficulty finding a match. This results in potentially unsatisfactory outcomes for the patients after SCT.
If a donor is not available, the current standard method of umbilical cord blood may be used. Gamia Cell will target these patients.
In addition, Gamia will also expand into other patient populations, especially patients who are susceptible to higher risk. This would include a mismatched donor source or if the patient’s minimal residual disease would preclude them from being eligible for a transplant.
Patients seeking a cure will find hope in Omisirge as it may offer a cure to the growing number of patients enduring severe haematological malignancies.