Tolebrutinib

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).