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iStock, Sundry Photography Darzalex Faspro’s approval for smoldering multiple myeloma could allow for earlier intervention and reduce the risk of progression to active disease. The FDA has signed off on Johnson & Johnson’s oncology blockbuster Darzalex Faspro for smoldering multiple myeloma, marking the first approved therapy for the indication. The approval indicates Darzalex Faspro for high-risk adult patients, who according to J&J, are more likely to progress to active disease within two years of being diagnosed. The expansion of Darzalex Faspro enables “earlier intervention and disease interception,” the pharma said on Thursday. The approval is backed by data from the Phase III AQUILA study , which enrolled nearly 400 patients and compared Darzalex Faspro intervention to active monitoring, also known as the watch and wait approach to surveillance. Results presented in December last year showed that the drug was able to significantly delay disease progression to active multiple myeloma, resulting in an overall 51% benefit versus active monitoring. This effect was more pronounced in those who were classified as high-risk, with Darzalex Faspro’s benefit reaching 64%. Treatment also improved overall survival by 48%. In May this year, the FDA’s Oncologic Drugs Advisory Committee voted 6–2 in favor of approving Darzalex Faspro for high-risk smoldering multiple myeloma. Administered under the skin, Darzalex Faspro is a monoclonal antibody designed to bind the CD38 protein, which is found on certain subsets of cells involved in the pathology of multiple myeloma. This mechanism of action allows Darzalex Faspro to block the growth of cancer cells and trigger their death. The drug is also approved for various types of multiple myeloma and light chain amyloidosis. Since first winning the FDA’s blessing in 2020, Darzalex Faspro has become one of J&J’s most valuable franchises. Last year, the product brought in more than $11.6 billion worldwide, accounting for more than half of the pharma’s cancer earnings. In the third quarter of this year, Darzalex Faspro emerged as J&J’s top-selling drug, hitting more than $3.6 billion in sales —nearly a 20% year-on-year growth. Darzalex Faspro’s label expansion on Thursday is the second bit of news for the multiple myeloma space in recent weeks. Late last month, the FDA allowed the comeback of GSK’s antibody-drug conjugate Blenrep, clearing its use for third-line multiple myeloma. That approval came despite an overwhelmingly negative adcomm vote in July. “The efficacy data were strong but the toxicity data were also very strong,” Neil Vasan, expert panelist and assistant professor at the Columbia University Medical Center, said during the committee meeting. Vasan voted against Blenrep’s approval.

GSK management is trying to infuse confidence in its long-term plan as the company delivered a strong quarter in Emma Walmsley’s final report as CEO. Emma Walmsley and her GSK CEO successor, Luke Miels, are safeguarding the British pharma’s 40 billion-pound-sterling sales projection for 2031 on the back of a strong quarter.The GSK executives are upholding the target despite the company’s multiple myeloma drug, Blenrep, returning to the U.S. market with a narrower-than-expected label. As one analyst pointed out on GSK’s third-quarter earnings call Wednesday, the current consensus estimate is 6 billion pounds below GSK’s own goal.“Our full team shared confidence in the short-, medium- and long-term outlooks,” Walmsley said on the call, adding that the gap in projections is largely in oncology and immunology and inflammatory diseases.“The number 40 is doable, and I stand behind it,” Miels said, echoing Walmsley. “Look, the majority of the products in it were forecast by me.”The third-quarter report is Walmsley’s last one as GSK’s CEO, as Miels, who most recently served as chief commercial officer, will take the baton Jan. 1, 2026.  To hear GSK Chief Financial Officer Julie Brown tell it, “Data readouts and commercial execution will make the difference.”Within oncology, Blenrep represents one area where GSK is more optimistic than bankers, Brown said. GSK’s views on its PD-1 inhibitor Jemperli’s pivotal readout as a neoadjuvant therapy in certain rectal cancer patients and the antibody-drug conjugates that GSK licensed from Hansoh Pharma are also different from analysts’ views, she said.Blenrep’s FDA approval last week as a third-line myeloma treatment—rather than a second-line label—together with a boxed warning on ocular toxicity and an FDA-mandated REMS safety restriction, caused some debate over the drug’s commercial prospects. GSK has previously put Blenrep’s peak sales potential at more than 3 billion pounds.There’s still “material opportunity” in the third line, and GSK has identified “a good pathway to getting to second line,” Walmsley noted on the call. The company has an ongoing phase 3 in newly diagnosed multiple myeloma, as well.“The really key thing to understand about Blenrep is that it is available in the community setting, which is where 70% of patients are,” Walmsley said on a separate call Wednesday with reporters. “It’s a 30-minute in-office infusion between five and eight times a year.”Despite the REMS requirement, the monitoring requirements are actually lighter than Blenrep had in its original launch in the late-line setting, with about half of the amount of data reporting burden than initially, Walmsley noted.Learning from Blenrep’s launch experience in the EU, GSK will focus on supporting physicians with the first few patients to ensure that they understand the dosing regimen to manage the eye toxicity, Miels said on the investor call.“The key […] is that, once people have experience with this product, they tend to be […] pleasantly surprised by the reputation leading into this versus the experience of using it,” Miels said. Outside of oncology, Brown noted that the difference between GSK’s estimate and consensus also exists in the long-acting biologic depemokimab, which awaits FDA decisions for the treatment of asthma with type 2 inflammation and for chronic rhinosinusitis with nasal polyps.The respiratory disease markets that depemokimab is targeting are competitive, Miels noted. But the incoming CEO designate highlighted depemokimab’s administration by a healthcare provider, coupled with long treatment intervals twice a year, as an advantage to ensure adherence and to keep disease exacerbation and hospital visits at bay.“This is probably the most market-researched product in GSK,” Miels said. “Eighty-six percent of pulmonologists say this could be a new standard of care when we show them the target label, and 82% of pulmonologists said they would consider using this product ahead of other [mechanisms of action]. So our strategy is very simple. It will be focusing on the naïve, new patients that are first going on to biologics.”GSK management is trying to infuse confidence in its 2031 plan as the company delivered a strong quarter in Walmsley’s final report as CEO. Its total quarterly revenue of 8.55 billion pounds landed 4% above analysts’ projections, with better-than-expected sales across departments in pharmaceuticals and vaccines. As a result, GSK increased its full-year guidance, now expecting 2025 turnover growth of between 6% to 7%, versus 3% to 5% previously.Two surprises came from vaccines as GSK’s flagship shingles vaccine Shingrix and RSV shot Arexvy beat consensus by 58% and 13%, respectively, according to Jefferies. While the third-quarter performance led GSK to expect it would land at the top end of its current vaccines guidance, Walmsley told reporters that “we remain very cautious about the environment in the U.S.”For Arexvy, its 36% sales growth year-over-year at constant currencies did not benefit from the U.S. market, where “lower pre-season channel inventory build together with slower market uptake” led to a decline, GSK said in its quarterly announcement.Rollouts in Europe also boosted Shingrix, which brought in sales of 830 million pounds during the quarter, good for 13% year-over-year growth at constant currencies. Again, the U.S. market proved to be a drag, with sales decreasing by 15% “due to the continuing slowdown in the pace of penetration of harder-to-activate unvaccinated consumers,” GSK said in its Oct. 29 release.GSK has seen a good sign in its pivot of Shingrix to focus on comorbid and high-risk subgroups in the U.S., Miels said. But the country will “still be tough, because of macro factors around vaccines,” he added.GSK is now building momentum for Shingrix outside the U.S. While the U.S. has reached an immunization rate of 43%, the number in the top 10 markets outside of the U.S. is around 10%, Miels noted.