Pfizer wins five FDA label updates for tofacitinib, ritlecitinib, abrocitinib; Crohn's trial halted

Pfizer's registry and regulatory activity this week was led by a batch of FDA label approvals, alongside a terminated Crohn's disease trial, completed studies in RSV vaccination and glioblastoma, and several new or ongoing oncology and infectious disease trials.

• The FDA approved five labeling supplements for Pfizer JAK inhibitor products, all with a submission status date of 2026-06-30: XELJANZ tablets (NDA203214, SUPPL 43)¹, XELJANZ oral solution (NDA213082, SUPPL 16)², XELJANZ XR (NDA208246, SUPPL 29)³, LITFULO capsules (NDA215830, SUPPL 1)⁴, and CIBINQO tablets (NDA213871, SUPPL 5)⁵.
• The Phase 2/3 "CULTIVATE" study of oral etrasimod in moderately to severely active Crohn's disease was terminated. The trial was designed to evaluate the efficacy, safety, and tolerability of oral etrasimod as therapy in adult participants with moderately to severely active Crohn's disease who are refractory or intolerant to at least one current therapy.⁶ The study enrolled 379 participants⁶, and the sponsor said the trial was "prematurely discontinued due to a lack of efficacy in sub-study 1."⁶
• The Phase 3 "MORISOT" study of the RSVpreF vaccine in pregnant women with HIV and their infants is now completed, with results first posted. The trial studied infants born to mothers living with HIV, who may have higher chances of getting sick or dying due to RSV infection.⁷ The study enrolled 681 participants⁷ and measured, among other outcomes, the percentage of maternal participants with prespecified local reactions within 7 days after vaccination.
• A Phase 1 study of atirmociclib (PF-07220060) in participants with varying degrees of hepatic impairment is now recruiting. The study aims to understand how the study medicine atirmociclib behaves in the body and how safe it is for people with different levels of liver health.⁸ The trial plans to enroll 28 participants⁸ and will measure maximum plasma concentration of the drug across hepatic function groups.
• Pfizer is a collaborator on a completed Phase 3 study of tofacitinib in recurrent glioblastoma led by UT Southwestern Medical Center. The trial enrolled 18 participants⁹ and assessed progression-free survival by RANO criteria as a primary outcome.
• Pfizer is sponsoring a real-world observational study using Epic Cosmos data to evaluate RSV vaccine effectiveness among non-pregnant adults, now active but not recruiting. The study compares ABRYSVO® (RSVpreF) with unvaccinated individuals in preventing RSV-related and all-cause acute respiratory illness (ARI), lower respiratory tract disease (LRTD), and other outcomes of interest.¹⁰ Estimated enrollment is 293,334 participants.¹⁰
• Pfizer is a collaborator on a new observational study sponsored by Sun Yat-sen University examining lipid management in patients on first-line lorlatinib for ALK-positive NSCLC in China. The study is not yet recruiting and plans to enroll 160 participants across an observational cohort and a randomized comparison of intensive versus standard lipid-lowering therapy.¹¹
• Pfizer is a collaborator on a new Phase 2 GOG Foundation-sponsored study of tisotumab vedotin in metastatic or recurrent squamous cell carcinoma of the vulva. The open-label, single-arm trial is designed to evaluate the efficacy of tisotumab vedotin by estimating the objective response rate.¹² The study is not yet recruiting and plans to enroll 28 participants.¹²