FDA approves ZAVZPRET label update; Pfizer registers RSVpreF and prostate cancer studies

The week's most significant update is a regulatory action on an approved product, alongside several newly posted trial registrations.

• The FDA approved a labeling supplement for ZAVZPRET (zavegepant hydrochloride), a nasal spray for migraine. The submission was numbered 8, classified as Labeling, with a submission status date of 2026-08-17.¹
• A Phase 3, open-label study will evaluate revaccination with RSVpreF in immunocompromised adults. The purpose is to learn the safety, tolerability and immunogenicity of revaccination with RSVpreF at approximately 1-, 2-, and 3-year intervals to inform the revaccination interval in immunocompromised adults.² The study is recruiting, with enrollment of 440 participants (estimated)².
• A new real-world observational study will compare enzalutamide plus ADT to darolutamide plus ADT in metastatic castration-sensitive prostate cancer. The purpose is to look back and compare time to next treatment after initial treatment with enzalutamide or darolutamide in addition to androgen deprivation therapy.³ The study is not yet recruiting, with enrollment of 4700 participants (estimated)³.
• Pfizer plans a Phase 3 trial of tilrekimig in severe asthma. The purpose is to learn about the safety and effects of tilrekimig for the potential treatment of severe asthma.⁴ The study is not yet recruiting, with enrollment of 1100 participants (estimated)⁴.
• A BioNTech-sponsored, Pfizer-collaborated Phase 1/2 trial testing combined flu and COVID-19 vaccines in healthy adults has completed. The study evaluated combined vaccine candidates against influenza and COVID-19 in healthy individuals.⁵ Results were first posted 2026-08-19, with enrollment of 1353 participants (actual).⁵
• A pregnancy registry for the PENBRAYA meningococcal vaccine is recruiting. The registry is designed to learn more about the safety of PENBRAYA when it is given during pregnancy or within 30 days before the last menstrual period.⁶ Planned enrollment is 50 participants (estimated)⁶.
• A continuation protocol will provide ongoing access to tucatinib for participants from closed parent studies across several cancer types. The purpose is to give continued access to tucatinib eligible participants and enable ongoing safety follow-up for those who continue to benefit from the study treatment.⁷ The study is not yet recruiting, with an estimated start date of 2026-11-06⁷.