Comeback stories are often the stuff of movies, but GSK is showing they can also happen in pharmaceuticals. The multiple myeloma medicine Blenrep has returned to the market three years after GSK voluntarily withdrew the product following the failure of the confirmatory study required of its accelerated FDA approval.
But drug approvals, like movie comebacks, have limits. GSK submitted the same new Blenrep clinical trial data to all drugs agencies, but did not get quite the same regulatory outcome in the U.S. While regulators in Europe and elsewhere approved Blenrep for use as a second-line multiple myeloma therapy, the new FDA approval permits the drug only as a third-line or later treatment for this blood cancer. In this setting, GSK is competing for market share against CAR T therapies and bispecific antibodies that address the same target as Blenrep.
GSK is offering an explanation for the FDA’s decision. In the context of this drug’s benefit-risk balance, the FDA took a different view than its counterparts in other countries, said Hesham Abdulla, GSK’s global head oncology, research & development. While the Phase 3 study called DREAMM-7 did yield positive overall survival data, that measure is not yet mature from the second Phase 3 study, DREAMM-8. But GSK continues to accrue clinical data, which it hopes will support further expanding Blenrep to earlier lines of treatment, he said.
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In the meantime, GSK has learned more about how to manage Blenrep’s complication risks. Like others in the class of medicines known as antibody drug conjugates (ADCs), Blenrep introduces the risk of eye toxicity. The additional clinical testing GSK conducted to support Blenrep’s new regulatory submissions gave the company a better understanding of this complication risk, Abdullah said. He added that GSK can now offer patients and clinicians a simpler, more streamlined Risk Evaluation and Mitigation Strategy (REMS), a plan the FDA can require of drugs with serious safety risks.
In an interview during the American Society of Hematology annual meeting in Orlando, Florida, just a few miles from the movie-based attractions of the Universal Studios theme park, Abdullah discussed GSK’s comeback plans for Blenrep. Responses have been lightly edited for length and clarity.
MedCity News: I’d like to talk about Blenrep. You finally got it over the finish line. But the FDA approval was for third-line use, and in Europe it’s approved for second-line use. So is there any disappointment there?
Hesham Abdullah: We’re not necessarily looking at it in the context of disappointment, but actually more in the importance of making this drug available to patients in the U.S. If you look at the U.S. product label as well, too, you see that the treatment effect both on PFS (progression-free survival) and overall survival, quite striking in that third-line plus segment of patients, which was a subgroup within DREAMM-7 as well. So we’re very excited about that.
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We’re very excited about the drug being made available to U.S. patients. We’re very excited about the fact that we have a REMS that has a very simplified data-collection program that helps at least decrease the burden on patients, physicians, and eye care professionals, which patients can access, whether it be optometrists or ophthalmologists as well, too. Now we’ve got to really focus on our development program and earlier lines of therapy as well.
MCN: Do you have an understanding of why you didn’t get second-line approval, and what more you need to get second-line from the FDA?
HA: There is the context, of course, of how regulators view benefit-risk. And I think probably as you alluded to earlier, we see that we’ve secured a second-line indication outside of the U.S., whether it be in Europe, the U.K., Switzerland, Canada, Japan, and other markets and regions based on the DREAMM-7 and the DREAMM-8 dataset. From a U.S. standpoint, I think regulators view benefit-risk in different contexts. Two things: One is we did have survival data from DREAMM-7, which was important. We saw statistically significant improvement in overall survival in the overall population. And the overall survival data is still not yet mature from DREAMM-8. So that’s one element why the DREAMM-8 component is not included in the indication in the U.S.
The second [point] really is that we’re going to continue to follow patients for overall survival, especially in DREAMM-7 and in earlier lines of therapy, specifically in the second-line subset of patients where the data is going to continue to mature and where certainly regulators in the U.S. continue to view the risk of the ocular, adverse events relative to the benefit, being important to be contextualized in the context of also seeing a survival benefit in that segment of patients as well. So again, because these patients typically live longer, the data in them is not yet mature. So we’re going to continue to follow patients at least in DREAMM-7 and the second-line subset, and then also the overall survival data as it continues to mature in DREAMM- 8.
Meanwhile, we’re going to be collecting a lot of data on post-marketing experience in the U.S. as the drug becomes more available. We take a very methodical, phased approach to how we launch the product in the U.S., making sure education is a really critical and foundational element of what we do.
One area we hear a lot from physicians about is once they get very familiar with how to use the dose-modification guidelines to manage the ocular adverse events, then it becomes much easier on them. And once that network of the patient to the physician to the eye care professional, and that iterative loop is established, we’ve got a lot of effort that we put into establishing those networks, especially with the eye care professionals throughout the U.S. as well too, which will make it probably easier over time.
About 70% of multiple myeloma patients are seen in a community setting. That’s really important to note, especially in the context of availability of other therapeutic modalities. Whether it be CAR Ts, whether it be bispecifics, which typically are much more limited to academic, comprehensive cancer centers because they do require hospitalization. They do have unique side effects similar to Blenrep, but those side effects need to be managed in more hospitalized and specialized centers. And not every patient has access to those. The most important element is we want to make sure we’re getting into the community setting where the majority of these multiple myeloma patients are to make sure we’re offering them new treatment options that can help them not only delay disease progression and increase the depth of response and its duration, but also prolong survival.
MCN: You said the current REMS is simpler. So was there an issue of accessibility in that the previous REMS was too complicated or cumbersome for physicians and patients?
HA: For Blenrep, back to when the drug was originally approved sometime in late 2020, we didn’t have a lot of information yet available on the eye-related side effects. We had data, limited follow-up from a single-arm study, which was the DREAMM-2 trial. Now we have data from two randomized, controlled Phase 3 studies, DREAMMs 7 and 8. We have an extensive safety database. We have a lot of length in terms of follow-up time. We know about the reversibility of these eye-related side effects as well too. We know they’re reversible. We know they’re manageable with the dose modifications, like implementing dose interruptions, dose reductions. And we know that they’re monitorable with eye exams.
MCN: Did this come from the feedback you got from clinicians, from the clinical studies?
HA: It did, absolutely. It’s based on the data that we’ve collected from these studies and then the follow-up time that we have as well. It’s fair to say that since 2020, and now we’re in late 2025, more than 7,000 patients have received Blenrep across the development program and in a post-marketing setting too. So it’s quite an extensive safety dataset for us to be able to look at and be able to best characterize what those ocular events are.
With that in mind, there was a lot of different data elements in terms of collection that were part of the initial REMS program. Those data collection points have been more simplified and more streamlined with the new REMS, whereby it will help at least decrease the burden on patients, the eye care professionals, and the physicians who then have to make a decision around administering the drug, not administering it, to hold it until the patient has recovered from their eye-related side effect, dose reduce the drug, etcetera.
MCN: So is Blenrep now available to patients?
HA: It is. We’ve dosed our first patients in the U.S. Things are moving ahead as planned, and the key is we’re going to continue to collect additional data and follow-up from DREAMM-7 and DREAMM-8 for survival. And we’re looking ahead to our development program, which is currently ongoing, in newly diagnosed patients in the frontline setting.
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