Imlunestrant

Dive Brief:Roche said Friday that the Food and Drug Administration will decide by Dec. 18 whether to approve its experimental drug giredestrant in breast cancer, setting the stage for a verdict that could intensify the competition surrounding a new class of oral, tumor-fighting medications. Roches submission was based on the results of a Phase 3 study that found giredestrant superior to older hormone therapies at keeping people with a certain type of advanced breast cancer alive without their disease getting worse. The pill has also since proven helpful to people in the adjuvant setting after surgery.If approved, giredestrant would become the third new oral SERD on the market, following clearances for Menarini Groups Orserdu and Eli Lillys Inluriyo. Roche believes giredestrant has the potential to stand out from its competitors, but faces persistent doubts about the class commercial outlook.Dive Insight:Roche executives have claimed giredestrant could replace the standard of care for the ER-positive, HER2-negative tumors that represent the majority of breast cancer cases.The drug may become the new backbone of choice for those tumors, said Teresa Graham, chief executive of Roches pharmaceuticals division, on a conference call with analysts last month. Graham noted how Roche is pursuing many combinations involving giredestrant and other in-house medications. Our phone keeps ringing as we are getting calls from potential partners too, she added.Roche will have to overcome skepticism, though.So far, oral SERDs like giredestrant have largely only proven helpful for a particular subset of patients with advanced disease, limiting their sales potential. In a research note earlier this month, for instance,Jefferies analyst Michael Leuchten questioned the drugs potential to meaningfully add to Roches revenue growth. Additional trials are needed, and the competition is hot on Roche's heels, Leuchten wrote on Feb. 2.Roche, for its part, has hinted that giredestrant might be more broadly beneficial than its peers. One of its pieces of evidence came from the evERA trial now supporting its approval submission. The people enrolled in that study had already seen their ER-positive breast cancer progress after receiving hormone therapy and so-called CDK 4/6 inhibitors.Roche enrolled a total of 373 people and randomized them to take an older drug called everolimus alongside either giredestrant or traditional hormone therapy. Those who got giredestrant had a 44% lower relative risk of dying or having their disease progress. Among people with mutations to a gene called ESR1 an alteration that occurs during or after exposure to hormone therapy the relative risk was 62% lower.Oral SERDs have so far only been approved for use in people with ESR1 mutations.If approved, giredestrant would join them. But Roche expects to submit data supporting use in the adjuvant setting in the coming weeks and also has a late-stage study underway in frontline breast cancer. Results from that trial are expected in the first half of 2026. '

Dozens of new drugs made the grade in 2025, and a clutch of newly commercial biopharma companies are now underway with their first launches. Photo by Sarah Silbiger/Getty Images How did staff layoffs, inspection backlogs and unprecedented leadership turnover affect the ability of the FDA to approve new drugs in 2025?While it would be presumptuous to base conclusions solely on the number of drugs the FDA approved in 2025, it is noteworthy that FDA nods of new treatments fell short of previous years, though a surge of green lights in December helped make the final numbers more respectable.There were 46 novel drug approvals in 2025, compared to 55 in 2023 and 50 in 2024. Meanwhile, the FDA’s Center for Biologics Evaluation and Research endorsed 18 new biological treatments in 2025, compared to 25 in 2023 and 18 in 2024.The surge in December included seven novel approvals, which was the most in any month of 2025. There also were many more novel approvals (30) in the second half of 2025 than in the first half (16), indicating that the U.S. regulator functioned more efficiently as it gained stability through the year.In March 2025, the Department of Health and Human Services announced a plan to cut 10,000 jobs, including 3,500 at the FDA. In the following months, scores of companies revealed delays for their product approvals that were initiated by the agency.A study from RBC Capital Markets revealed there were more marketing applications rejected in the third quarter of last year than in the previous six periods. Additionally, the FDA delayed 11% of the reviews of those applications in the third quarter compared to an average delay rate of 4% from the previous six quarters.Decline in potential blockbusters In addition to the decline in approvals in 2025, there was a drop in the number of new meds that are expected to generate blockbuster sales.In 2024, there were nearly 20 new products approved that were expected to deliver sales of at least $1 billion by 2030, according to Evaluate Pharma. On this year’s list, only eight newly approved medicines carry those expectations.In the last two weeks of December, Cytokinetics secured a nod for cardiomyopathy treatment Myqorzo and GSK scored with asthma medicine Exdensur. Myqorzo has been projected by Evaluate Pharma to generate sales of $2.8 billion by 2030, with Exdensur’s estimate at $1.2 billion.Of the new drugs that were approved in 2025, the one expected to generate the highest sales by 2030 is AstraZeneca and Daiichi Sankyo’s Datroway, which is the first TROP2-directed antibody-drug conjugate to treat breast cancer. Five months after it was approved, the companies earned an FDA clearance to treat patients with non-small cell lung cancer (NSCLC) who have EGFR mutations.The new drug projected to generate the second-most revenue in 2030 is Insmed’s Brinsupri, which is the first DPP1 inhibitor to reach the market. It also is the first treatment for non-cystic fibrosis bronchiectasis and is projected to reach sales of $3.1 billion in 2030.Other products approved in 2025 that are expected to be blockbusters by 2030 are Vertex’s non-opioid pain reliever Journavx, Novartis’ Rhapsido for chronic spontaneous urticaria, Johnson & Johnson’s Imaavy for generalized myasthenia gravis and GSK’s Penmenvy, a meningococcal vaccine.There were many more high-profile drugs approved in 2024, including Madrigal Pharmaceuticals' Rezdiffra for metabolic dysfunction-associated steatohepatitis; Merck’s Winrevair for pulmonary arterial hypertension; Bristol Myers Squibb’s Cobenfy for schizophrenia; J&J’s Lazcluze for NSCLC; BridgeBio’s Attruby for cardiomyopathy; Vertex’s Alyftrek for cystic fibrosis; and a pair from Eli Lilly—Alzheimer’s disease treatment Kisunla and atopic dermatitis therapy Ebglyss.   Treatment types in 2025 The FDA signed off on 14 oncology treatments last year compared to 15 in 2024. Of the 14, five are for NSCLC, including two for non-squamous NSCLC. The splurge of NSCLC nods came after the FDA blessed three new treatments in the indication in 2024. In addition to AstraZeneca and Daiichi Sankyo’s high-profile approval for breast cancer drug Datroway, Eli Lilly also scored a nod for its breast cancer treatment Inluriyo.The FDA gave its thumbs-up to two blood cancer treatments: Kura Oncology and Kyowa Kirin’s Komzifti for acute myeloid leukemia and Regeneron’s Lynozyfic for multiple myeloma. It’s a continued slowdown from 2023, when the FDA signed off on seven new blood cancer therapies.Of the FDA’s 46 novel drug approvals in 2025, 26 (57%) were designated as rare disease (orphan) treatments. Drugs that are for diseases with fewer than 200,000 patients in the U.S. are slotted into the orphan category. It was a higher rate of rare disease treatments than in the previous two years, when just over half of the new approved drugs were for orphan diseases.Three of the orphan approvals were for the same disorder, hereditary angioedema (HAE), and came in a span of 10 weeks. The splurge began with a nod for CSL’s Andembry. The FDA also endorsed Ionis Pharmaceuticals’ Dawnzera, which is the first RNA-targeted treatment for HAE. The other approval came for KalVista Pharmaceuticals' plasma kallikrein inhibitor Ekterly, which differs from the other injected treatments in that it is taken orally and is used on demand to quell acute attacks of HAE.After a record number of new cell and gene therapy (CGT) approvals in 2024 with nine, there was a slowdown in CGT nods in 2025 with five. It was the fewest since 2022, when the FDA also issued five CGT approvals. With the exception of Novartis’ nod for spinal muscular atrophy treatment Itvisma, the approvals were scored by small companies Abeona, Precigen, Neurotech and Fondazione Telethon, an Italian firm that became the first nonprofit to get a CGT across the FDA finish line. European companies excel in 2025 European companies won many more approvals for new products than their counterparts in the U.S. In fact, no U.S. company earned more than one FDA nod in 2025. Meanwhile, five European companies scored multiple FDA approvals last year.GSK and Novartis achieved three approvals each. GSK earned its nods for meningococcal vaccine Penmenvy, urinary tract and gonorrhea antibiotic Blujepa and severe asthma treatment Exdensur. Novartis won approvals for nephropathy drug Vanrafia, urticaria medicine Rhapsido and spinal muscular atrophy gene therapy Itvisma.The companies with two FDA endorsements were Sanofi, which secured endorsements for thrombocytopenia therapy Wayrilz and hemophilia drug Qfitlia; Boehringer Ingelheim, which won over the regulator with idiopathic pulmonary fibrosis drug Jascayd and lung cancer treatment Hernexeos; and Bayer, which scored with menopause treatment Lynkuet and lung cancer therapy Hyrnuo.It was a lean year for U.S. Big Pharma as AbbVie, Eli Lilly, Johnson & Johnson, Merck and Regeneron were the only top 20 companies that gained approvals for new drugs.Note: The numbers for our annual roundup typically vary slightly from the FDA's official list, because our report includes approvals for biologic therapeutics and vaccines but excludes diagnostic imaging agents, which are represented on the FDA's list.