Fredrik Schjesvold, MD, PhD, Discusses the Implications of an FDA Approval for Melflufen in Transplant-Naïve Relapsed/Refractory Multiple Myeloma

CancerNetwork® sat down with Fredrik Schjesvold, MD, PhD, at the 2021 International Myeloma Workshop to talk about how he would like to see the OCEAN trial and Melflufen progress for relapsed/refractory multiple myeloma.

At the 2021 International Myeloma Workshop, CancerNetwork® spoke with Fredrik Schjesvold, MD, PhD, founder and head of the Oslo Myeloma Center, about the potential of an FDA approval for melflufen (Pepaxto) in patients with transplant-naïve relapsed/refractory multiple myeloma, and the possible implications for this patient population.


First, we have to wait for the FDA’s decision, which will come later this fall. What I do expect them to decide—and I think it will be the correct decision—is that this drug should be developed further in patients who are non-transplanted. If that’s the decision, I think that lays the groundwork for an approval of melflufen in this particular population. [This] means [patients who have has] at least 2 previous lines [of therapy] and [who are] lenalidomide [Revlimid]-refractory [among] patients who have not received a transplant. [Melflufen will] probably not be approved for patients who have received a transplant, especially recently. Of course, the problem with this is that this is not how most approvals are. But there are examples of approvals that have been based on subgroups when there have been discrepancies in which patients benefit from which drugs.

If the FDA approves [this agent] for the non-transplanted group, [it] could be established as a new standard in patients who otherwise would have received pomalidomide. Further studies will show if there are other combinations because this a combination only with dexamethasone. There are ongoing studies with recommendations, especially with the daratumumab (Darzalex), which is the most mature of the combination studies. When this study was performed, daratumumab was not as common as it is today in the second- or third-line [setting]; we saw that in the patient population. But it will be and then melflufen/dexamethasone plus daratumumab might be an option. There’s still some way to go there. First, we must get the partial clinical hold lifted, and that will probably induce patient selection for further studies and then for approvals.


Schjesvold F, Dimopoulos MA, Delimpasi S, et al. OCEAN (OP-103): a Phase 3, randomized, global, head-to-head comparison study of melflufen and dexamethasone (Dex) versus pomalidomide (Pom) and dex in relapsed refractory multiple myeloma (RRMM). Presented at: International Myeloma Workshop; September 8-11, 2021; Vienna, Austria. Accessed September 11, 2021.