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GSK CEO Emma Walmsley said the company is steadfast in bringing Blenrep back to the US market after several FDA setbacks. In its second-quarter earnings report Wednesday, the company also revealed a Phase 3 trial of various combinations featuring its anti-TIM-3 antibody, called cobolimab, had failed. Walmsley said in a media call GSK is “very confident in the Blenrep data, and really pleased that we have an updated PDUFA date.” She added that “we are in constructive dialogue with the agency: answering questions, providing some additional data.” GSK has previously said Blenrep could reach £3 billion ($4 billion) a year in global sales in second-line multiple myeloma. Last week, the FDA extended its review of Blenrep by around three months after an advisory committee largely voted against the risk-benefit profiles of two separate combinations including the drug for second-line disease. The agency now has until Oct. 23 to make a decision. During the meeting, committee members raised their concerns over the fact that just 5% of patients included in Blenrep’s clinical development were from the US, as well as the limited enrollment of African American patients. “The representation of our studies was consistent with other studies for approved multiple myeloma indications in the US designed as global registrational studies,” Walmsley said on the call. “We did have a significant profile of European countries, but all of the demographics and outcomes in those countries are also consistent with the US.” This is GSK’s second attempt to get Blenrep past the finish line. The medicine was originally greenlit in 2020 under an accelerated approval pathway, but the company voluntarily pulled it from the US market in 2022 after it flunked a confirmatory trial. The drug was approved in Europe last week. Elsewhere in its oncology pipeline, the UK drugmaker’s Phase 3 trial of its anti-TIM-3 antibody cobolimab in doublet or triplet combinations with Jemperli and docetaxel in non-small cell lung cancer ended in failure last month. The study missed its primary endpoint of improving overall survival in pretreated patients. GSK also removed two programs from Phase 2 development: A recombinant protein codenamed GSK3437949 for malaria, and a serine beta-lactamase inhibitor called sanfetrinem cilexetil for tuberculosis. The malaria drop comes as the company is shifting its focus to second-generation vaccines for the disease, a spokesperson told Endpoints News in an email. The tuberculosis asset “has not compared favourably in early studies to existing treatments,” they said. Elsewhere, Walmsley said that GSK is in dialogue with the Trump administration on how to “keep the US leading the world in terms of being a market for innovation, and to make sure that we are passing on the discounts that we provide to patients.” She declined to provide further details of the talks, but noted the company “would like to see all countries investing more and recognizing the value more that [healthcare] innovation brings.” Walmsley is the latest big pharma CEO, along with AstraZeneca’s Pascal Soriot and Roche’s Thomas Schinecker , to mention discussions with the Trump administration on US drug prices. The UK pharma’s Q2 sales came in 2% ahead of Wall Street consensus estimates at £8 billion ($10.7 billion). The success was largely driven by GSK’s vaccines franchise, which saw sales increase 9% from the same period last year to £2.1 billion ($2.8 billion). In particular, the £853 million in sales for shingles vaccine Shingrix were buoyed by launch uptake in France and continued demand in other European markets and Japan. GSK’s share price is up 1.5% on the London Stock Exchange.

Drug approval delays have become more common since the FDA lost 19% of its workforce in April due to federally mandated budget cuts. After losing 3,500 employees in April—19% of its workforce due to congressional budget cuts—the FDA is now struggling to meet drug approval deadlines. The latest example is its failure to rule on Bayer’s menopause treatment, elinzanetant.On Friday, the German company said in a release that the FDA needed additional time to review its new drug application for elinzanetant, extending the Prescription Drug User Fee Act (PDUFA) review period by up to 90 days.The FDA was expected to make its decision by Saturday on the application, which was filed in August 2024. The new PDUFA date is Oct. 26.Bayer added that the FDA did not “raise any concern regarding the general approvability” of elinzanetant. Earlier this month, regulators in the U.K. endorsed the treatment, which is known commercially as Lynkuet. Canada followed suit last week with a thumbs-up, while a review is ongoing by the European Union.“We are confident in the potential of elinzanetant to provide meaningful clinical benefit to women pending regulatory approval,” Yesmean Wahdan, M.D., Bayer’s head of medical affairs in North America, said in a statement. “We continue to work with the FDA to make this treatment available.”Analysts at Barclays wrote that the delay was a “small negative” for Bayer, which has tabbed peak sales for the treatment at 1 billion euros ($1.2 billion). The company will likely add more details during its second-quarter earnings presentation on Aug. 6.Over the past four months, the FDA has delayed its review of several drugs, but most decisions have still arrived relatively quickly. In May, the agency approved GSK’s Nucala for COPD less than two weeks after its original PDUFA date.In July, the FDA signed off on KalVista’s rare disease drug Ekertly three weeks after its original PDUFA date. And in April and May, it took an extra six weeks to convert Novavax’s COVID-19 vaccine from accelerated to full approval. In May, the FDA took an extra month to reject a rare-disease drug from Stealth BioTherapeutics, though that application has been through a series of regulatory challenges since the Massachusetts company first presented data in 2019.Last week, the FDA also delayed a decision on GSK’s multiple myeloma drug Blenrep by 90 days, which was voted down as an agent in two separate combinations by an FDA advisory committee earlier this month.As for Bayer, it is hoping to join Astellas as the second company with a hormone-free treatment for patients with moderate to severe hot flashes that accompany menopause. While Astellas’ Veozah was the first neurokinin 3 (NK-3) receptor antagonist approved for the indication, Lynkuet is the first dual-action neurokinin in the indication, targeting the NK-3 and NK-1 receptors. Astellas reported 2024 fiscal year sales of Veozah at 33.8 billion yen ($230 million), which came up short of its expectations. Astellas has projected fiscal 2025 sales at 50 billion yen ($340 million). The company's peak sales projection for the treatment, which carries a black box warning for potential liver damage, is $3.6 billion.Despite being from the same treatment class, Lynkuet has shown scant evidence of the side effects in three phase 3 trials.