Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today positive final results from the overall survival (OS) analysis of the Phase III INAVO120 study. These data showed ItovebiTM (inavolisib), in combination with palbociclib (Ibrance®) and fulvestrant, reduced the risk of death by more than 30% compared with palbociclib and fulvestrant alone. This represents a statistically significant and clinically meaningful improvement in overall survival for people with PIK3CA-mutated, hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, endocrine-resistant, locally advanced or metastatic breast cancer. The results are being presented in an oral session at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting and simultaneously published in the New England Journal of Medicine (NEJM).
Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today new, 96-week data for fenebrutinib demonstrating that patients with relapsing multiple sclerosis (RMS) maintained no disability progression and low levels of disease activity for up to two years. The latest results for this investigational Bruton’s tyrosine kinase (BTK) inhibitor from the Phase II FENopta open-label extension (OLE) study were presented at the Consortium of Multiple Sclerosis Centers (CMSC) Annual Meeting in Phoenix, Arizona.
Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today two-year follow-up data from the Phase III STARGLO study. After a median follow-up of 24.7 months, data showed a 40% improvement in overall survival (OS) for patients treated with Columvi® (glofitamab-gxbm) in combination with gemcitabine and oxaliplatin (GemOx) and median OS was not reached, compared to 13.5 months for Rituxan® (rituximab) plus GemOx (R-GemOx). These updated data continue to demonstrate the statistically significant and clinically meaningful survival benefit of this off-the-shelf, fixed-duration Columvi combination for people with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) who have received at least one prior line of therapy and are not candidates for autologous stem cell transplant (ASCT). Data will be presented in an oral session at the 61st American Society of Clinical Oncology (ASCO), May 30 – June 3, 2025.
Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY) announced today that the U.S. Food and Drug Administration (FDA) has approved Susvimo® (ranibizumab injection) 100 mg/mL for the treatment of diabetic retinopathy (DR), a potentially blinding condition that affects almost 10 million people in the U.S. and more than 100 million people globally. It is the first and only FDA-approved continuous delivery treatment shown to maintain vision in people with DR with just one refill every nine months. Susvimo is now available to U.S. retina specialists and their patients with DR who have previously responded to at least two anti-vascular endothelial growth factor (VEGF) injections.
Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that a U.S. Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee (ODAC) discussed the supplemental Biologics License Application (sBLA) for Columvi® (glofitamab-gxbm) in combination with gemcitabine and oxaliplatin (GemOx) for the treatment of people with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) who are not candidates for autologous stem cell transplant (ASCT).
Merck's Phase 3 trial of Keytruda plus chemo met progression-free survival and overall survival goals in platinum-resistant ovarian cancer, including patients with PD-L1–positive tumors.
Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), the Breast International Group (BIG), Institut Jules Bordet Clinical Trials Support Unit and Frontier Science Foundation, announced today statistically significant final overall survival (OS) results from the Phase III APHINITY study in people with human epidermal growth factor receptor 2 (HER2)-positive early-stage breast cancer. After ten years, the risk of death was reduced by 17% for people treated with Perjeta® (pertuzumab), Herceptin® (trastuzumab) and chemotherapy (the Perjeta-based regimen) for a year as post-surgery (adjuvant) treatment, compared with individuals who received Herceptin, chemotherapy, and placebo.
JPMorgan analysts said President Trump’s "most favored nation" drug pricing order is unlikely to move forward without Congressional support and will likely face legal and industry resistance, limiting its near-term impact on pharma stocks.
Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today plans to invest more than $700 million in a new 700,000 square foot state-of-the-art drug manufacturing facility in Holly Springs, NC.
What Happened: On Sunday, President Donald Trump announced on Truth Social that he plans to sign what he called the "most consequential executive order" in U.S. history, aimed at lowering prescription drug prices.
Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY) announced today that the New England Journal of Medicine (NEJM) has published a detailed analysis of the Phase III CENTERSTONE trial of Xofluza® (baloxavir marboxil). The trial met its primary endpoint, showing a single, oral dose of Xofluza taken by people infected with influenza reduced the odds of untreated household members contracting the virus by 32%. For the key secondary endpoint of influenza virus transmission resulting in symptoms, Xofluza showed a clinically meaningful reduction although statistical significance was not reached. Xofluza was well tolerated, with no new safety signals identified.
