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Follicular lymphoma is a slow-growing form of NHL arising from B-lymphocytes. Credit: evan_huang/Shutterstock.com. The US Food and Drug Administration (FDA) has approved AbbVie’s Epkinly (epcoritamab-bysp) to treat adult patients with relapsed or refractory (R/R) follicular lymphoma (FL). The approval is for the use of the T-cell engaging bispecific antibody, Epkinly, administered subcutaneously, in combination with rituximab and lenalidomide (Epkinly + R²). It is supported by data from the Phase III Epcore FL-1 study, which assessed the fixed-duration of the combination therapy against the standard treatment of R². The findings highlight the potential to transform treatment strategies for FL, a slow-growing form of non-Hodgkin lymphoma (NHL) arising from B-lymphocytes, affecting 15,000 new patients annually in the US. The Epcore FL-1 trial enrolled a broad patient population, showing that Epkinly in combination with R 2 lowered the risk of disease progression or mortality by 79% comparison to R 2 alone. The overall response rate was 89% for Epkinly + R 2 versus 74% for R 2 . Median progression-free survival was not reached in the Epkinly group versus 11.2 months for R 2 . Complete responses were achieved in 74% of patients receiving Epkinly + R 2 compared to 43% with R 2 . GlobalData Strategic Intelligence US Tariffs are shifting - will you react or anticipate? Don’t let policy changes catch you off guard. Stay proactive with real-time data and expert analysis. By GlobalData Learn more about Strategic Intelligence AbbVie oncology, solid tumour and haematology therapeutic area head and vice-president Daejin Abidoye stated: “With this approval, Epkinly is now the first bispecific antibody available for patients with follicular lymphoma in the second-line plus setting. New options are needed to improve outcomes for patients with relapsed or refractory disease.” Epkinly as a single agent received accelerated approval from the FDA in June 2024 to treat R/R FL after two or more lines of systemic therapy. Additional international regulatory submissions are scheduled. In October 2025, the FDA approved AbbVie’s supplemental new drug application , updating the indication statement for Rinvoq (upadacitinib) to treat inflammatory bowel disease. Pharmaceutical Technology Excellence Awards - The Benefits of Entering Gain the recognition you deserve! The Pharmaceutical Technology Excellence Awards celebrate innovation, leadership, and impact. By entering, you showcase your achievements, elevate your industry profile, and position yourself among top leaders driving pharmaceutical advancements. Don’t miss your chance to stand out—submit your entry today! Nominate Now

Pfizer seals the deal with Metsera for $10 billion after Novo Nordisk bowed out; President Donald Trump welcomes executives from Novo and Eli Lilly to the White House to announce that the companies’ GLP-1 medicines would be sold at a reduced cost; and the FDA grants the second round of priority review vouchers—primarily to already marketed drugs. > Listen on Spotify > Listen on Apple Products > Listen on Amazon Music > Listen on iHeart One of biopharma’s most memorable bidding wars finally came to an end on Friday—with Metsera right back in the arms of its original suitor, but with Pfizer paying around $10 billion for the rights to the obesity biotech, a nearly $3 billion increase over its original bid. But while Novo Nordisk may have bowed out of that race, the company still made headlines this past week, with CEO Maziar Mike Doustdar joining Eli Lilly head David Ricks at the White House on Thursday to announce a deal that will see their GLP-1 drugs offered at about $350 per month. This marks a significant discount to the current list prices of $1086 and $1350 for Lilly’s obesity drug Zepbound and Novo’s comparator Wegovy, respectively. No matter how low they go, however, the GLP-1 leaders can still be undercut by compounders, Steven Grossman, policy and regulatory consultant and author of the FDA Matters blog, told BioSpace this week. Speaking of Lilly, the Indianapolis-based pharma had a busy week, reporting 20% weight loss in a mid-stage study of its amylin agonist eloralintide that William Blair analysts said “validates [the] amylin agonist class.” Lilly also netted two new partners, inking a $1.2 billion RNAi pact with SangeneBio to target metabolic diseases and licensing a genetic eye disease therapy from MeiraGTx Holdings for up to $475 million. On the regulatory front, the FDA awarded the second round of priority review vouchers under its new Commissioner’s National Priority Vouchers program. Unlike the first cohort of vouchers, which was announced in October, this group mostly consisted of products already on the market—with the exception of Lilly’s orforglipron. Finally, BioSpace dives into one the hottest trends in the immunology and inflammation (I&I) space— pipeline-in-a-product . Possibly motivated by blockbuster drugs like AbbVie’s Skyrizi and Rinvoq and Regeneron and Sanofi’s Dupixent, companies are optimizing shots on multiple goals in this lucrative space.