Giredestrant

A potential FDA approval of giredestrant in breast cancer and a phase 3 readout for fenebrutinib in relapsing multiple sclerosis are key events in 2026 for Roche's pharma division, which is led by Teresa Graham. Roche is looking to a busy 2026 after 10 new molecules entered late-stage testing last year and as a potential launch of closely watched breast cancer candidate giredestrant draws near.But behind another strong report marked by a 9% annual sales growth at constant exchange rates in the pharmaceutical division, a miss from the star eye drug Vabysmo stood out.With 4.1 billion Swiss francs ($5.3 billion) in sales in 2025, Vabysmo was Roche’s No. 3 drug by sales, a remarkable feat considering the bispecific antibody was first approved by the FDA in 2022.Nevertheless, the drug’s 1 billion Swiss francs haul in the fourth quarter undershot analysts’ consensus by 8%, according to Jefferies. Its sales in the second half of 2025 were 32 million Swiss francs lower than in the first half. Ophthalmology market dynamicsThe slowdown was caused by the “contraction of the U.S. branded market” of anti-VEGF drugs for conditions such as wet age-related macular degeneration, Roche’s pharma chief Teresa Graham told investors on a conference call Thursday.“We saw a big reset in the branded market in the U.S.,” Graham said. “With the closure of the copay foundations, fewer patients were put on branded drugs, [and] more patients were put on Avastin and biosimilars.”The branded intravitreal injection market in the U.S. shrank by 15% throughout 2025, Graham noted. Despite the overall market slowdown, Vabysmo still gained market share, according to Roche. And these days, more than 60% of Vabysmo patient starts in the U.S. are from treatment-naïve individuals, which Graham said “further solidifies Vabysmo’s position as the standard of care.” The Swiss pharma expects a growth acceleration for Vabysmo in 2026 driven by ex-U.S. launches and recovery in the U.S.What gives Roche confidence in a recovery is what’s known as “the blizzard,” Graham explained. In the next few months, retinal specialists in the U.S. are expected to reverify their patients' insurance benefits. As new coverage plans take effect and deductibles and out-of-pocket costs reset, patients will determine whether to stay on existing medications or switch. That should allow Roche to “see the actual branded growth” without the effect of donations, as people go on to new therapies, she said.But as one analyst pointed out on the call, more competition could be coming in addition to Regeneron’s Eylea franchise. Ocular Therapeutix is nearing a pivotal wet AMD readout for its Axpaxli, which is administered less frequently at six months between doses. Vabysmo allows for treatment intervals of up to four months. Doctors already have a lot of good experience in extending doses with Vabysmo, Graham noted. As to the Ocular product, Graham argued that a well-defined safety profile will give Vabysmo an advantage.“This drug is going into phase 3 with a very small safety database and really no known data on long-term safety,” the Roche exec said of the competitor. “When you talk about something that’s [administered] interocularly over a long period of time, long-term safety is incredibly important.”Previously, a safety concern tripped up Novartis’ once-hyped anti-VEGF eye drug Beovu even after its FDA approval. Tecentriq trial miss Besides the Vabysmo slowdown, Roche snuck a piece of bad news from its oncology department into its full-year earnings report. After a long wait, Roche has called its quits on a phase 3 trial of Tecentriq as a perioperative treatment for resectable early-stage non-small cell lung cancer.The phase 3 IMpower030 trial did not meet its primary endpoint of event-free survival in the overall study population, a Roche spokesperson confirmed to Fierce Pharma. That’s a big disappointment for the brand, considering that Merck & Co.’s Keytruda, Bristol Myers Squibb’s Opdivo and AstraZeneca’s Imfinzi have all been approved as part of separate perioperative treatment regimens in resectable NSCLC.Despite the flop, Tecentriq demonstrated a clinically meaningful improvement of EFS in the subgroup of patients with wild-type tumors without EGFR or ALK genomic alterations, the spokesperson noted.Tecentriq returned to growth last year with sales of nearly 3.6 billion Swiss francs. Roche’s oncology business—excluding blood cancer drugs—grew sales by 2% year over year at constant exchange rates, driven by the company's HER2 franchise. But with continued biosimilar erosion and competitive pressure from AZ and Daiichi’s antibody-drug conjugate Enhertu, Roche expects sales from its HER2 franchise will peak this year at about 9 billion Swiss francs.Meanwhile, attention on Roche’s oncology portfolio is shifting from HER2 to the oral SERD drug giredestrant, which the company suggests could replace existing standard-of-care endocrine therapy in HR-positive breast cancer.The Swiss pharma has filed giredestrant in second-line HR-positive, HER2-negative breast cancer with the FDA and expects to do the same for its adjuvant use in early breast cancer in the first half of this year. A phase 3 readout from the persevERA trial in the first-line setting is also expected this year. BTK inhibitor updateAnother key phase 3 readout Roche expects this year is FENhance 1, the second for fenebrutinib in relapsing multiple sclerosis. Investors were getting anxious after the FDA turned down Sanofi’s rival BTK inhibitor tolebrutinib. But Graham argued that people should not apply tolebrutinib’s case to fenebrutinib.“We have to be very, very cautious here,” she said. “If you actually read that [complete response letter], it is incredibly specific to the risk-benefit that was seen with tolebrutinib. And unfortunately, they had a number of failed trials. They had a number of Hy’s law cases.” The FDA identified six cases in Sanofi’s phase 3 program that met Hy’s Law—a principle for assessing the risk of drug-induced liver injury—out of 2,700 total patients. Roche’s fenebrutinib program also experienced a liver toxicity signal. One of the two cases of elevated liver enzymes that caught the FDA’s attention met Hy’s Law, and the other one was confounded by alcohol use. The one confirmed case is from FENhance 1, which remains blinded, according to Graham. “It’s also really important to note that since we put liver monitoring in place in the clinical trials, we have not seen any more cases,” Graham said. “So I think we feel very good about the overall benefit-risk profile that we have with fenebrutinib, particularly when you consider the other half of that coin, which is the benefit.”All told, Roche’s group sales grew by 7% at constant exchange rates to 61.5 billion Swiss francs in 2025, including 47.7 billion from the pharma division. 

With two positive clinical readouts in the bag, a US approval filing, and another important trial due to report in a couple months, Roche’s breast cancer drug giredestrant is sitting pretty. Management is hugely confident in the pill. CEO Thomas Schinecker said on a call with journalists Thursday it could become “our biggest-selling medicine that we’ve ever sold.” The Swiss pharma is basing this opinion on data from the evERA and lidERA trials. Giredestrant is a selective estrogen receptor degrader, or SERD. The first of these trials indicated that the drug works when used as second-line therapy for certain breast cancer patients, and the other study suggested that it can delay tumor recurrence. “I absolutely believe that [giredestrant] will change the standard of care,” Teresa Graham, the head of Roche’s pharmaceuticals division, said on the call. “You can’t look at the results from lidERA and not believe that that’s going to be true.” She added that Roche expects approval and “modest” sales of the SERD this year. In terms of future revenues, Roche is only saying that giredestrant’s peak sales will top $3 billion. But the figure will end up much higher if giredestrant does indeed become the company’s biggest-ever money-spinner. Sales of the company’s cancer drug Rituxan, for instance, peaked at $7.8 billion in 2013. If giredestrant is going to smash that record, an ongoing trial assessing it as a first-line breast cancer therapy will have to succeed convincingly. Data from the persevERA study will come out in March or April, Graham said. There was a clear contrast in sentiment surrounding another of Roche’s pipeline products. The multiple sclerosis drug fenebrutinib has also yielded positive late-stage data and has another crucial readout on the way, but a similarly acting drug from Sanofi was recently rejected by the FDA. Graham professed herself that she was only “fairly” or “pretty” confident that fenebrutinib’s upcoming Phase 3 trial would hit. The ongoing trial is called FENhance 1, and is testing the BTK inhibitor in the relapsing form of MS. Data are expected in the first half of 2026, and if they are positive, the drug could be filed this year. But the knockback of Sanofi’s BTK, tolebrutinib, is a bad omen. Graham said that the FDA’s complete response letter was “very specific to the risk-benefit profile of tolebrutinib,” and shouldn’t be extrapolated to other molecules. She argued that the safety profile of fenebrutinib was “fairly well-established.” Elsewhere, the company culled a handful of drugs from its pipeline, including vixarelimab, which had been in Phase 2 for idiopathic pulmonary fibrosis and scleroderma-associated interstitial lung disease. Roche paid $80 million upfront to license vixarelimab from Kiniksa in 2022. Roche had already canned a Phase 2 trial of the drug in ulcerative colitis. In June 2025, the Moonglow trial was marked as terminated on the federal clinical trials database, as a futility analysis had suggested it was unlikely to meet its primary endpoint. It also ended a Phase 3 trial of its checkpoint inhibitor Tecentriq, used before and/or after surgery for non-small cell lung cancer, and Phase 1 trials of zifibancimig, a bispecific targeting VEGF and angiopoietin 2, in neovascular age-related macular degeneration. It stopped an early study of an LTBR agonist called RG6221 in solid tumors, too. Schinecker and Graham were speaking on a call to discuss Roche’s annual earnings. The CEO said the company had “truly very much a record year” in 2025, with its overall sales growing by 7% at constant exchange rates to CHF61.5 billion ($80.1 billion), and its drugs division by 9% to CHF49.7 billion ($62.1 billion).