Study Finds No Additional Benefit from Multiple Myeloma Drug


Pomalyst was approved in 2013 for use in combination with dexamethasone to inhibit tumor growth.

A drug for difficult-to-treat and recurrent multiple myeloma was found to have no added benefits in a recent trial.

Multiple myeloma is a life threating rare cancer where the bone is damaged, the immune system is weakened, and blood formation is impaired as a result of plasma cells that became abnormal and uncontrollably multiply in the bone marrow.

The drug pomalidomide (Pomalyst) was approved in 2013 for use in combination with dexamethasone to inhibit tumor growth in adults who have had 2 or more prior treatment regimens that included lenalidomide and bortezomib without inhibiting tumor progression.

The German Institute for Quality and Efficiency in Health Care examined a report to determine if the drug offered any benefits over the comparator therapy, but none could be determined because of unsuitable date in the study.

In a report created by the Federal Joint Committee (G-BA), researchers specified the different appropriate comparator therapies for 2 different patient groups. Patients who are able to have targeted therapy should receive individual treatment specified by their physician in compliance with the approval. This therapy is also dependent on other treatments that have been tried.

For patients where targeted therapy is no longer an option, the best supportive care should be used, according to the study. This provides patients with the best supportive and individualized treatment that alleviates symptoms and improves their quality of life.

The report showed that no relevant data was collected from the 2 patient groups. Investigators compared the combination of Pomalyst and low-dose dexamethasone versus uniform administration of high-dose dexamethasone to participants in the control arm, but treatment adjustments were not possible in the study.

Also, since the high dosage of dexamethasone is not in compliance with the approval, the individual targeted therapy specified by a physician was not able to be executed sufficiently and was therefore considered inadequate.

There was also no study data for patients without targeted therapy, so the report showed no added benefit of Pomalyst.

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