Tirabrutinib for Relapsed/refractory primary CNS lymphoma
The FDA is expected to decide on Tirabrutinib for Relapsed/refractory primary CNS lymphoma by December 18, 2026, under a NDA from Deciphera Pharmaceuticals.
What is being decided
Deciphera Pharmaceuticals has an NDA under FDA review for Tirabrutinib in Relapsed/refractory primary CNS lymphoma. BTK inhibitor already approved in Japan for this rare brain lymphoma.
About the drug
Tirabrutinib: highly selective, irreversible second-generation Bruton tyrosine kinase (BTK) inhibitor that shuts off B-cell receptor signaling in lymphoma cells. Our full Tirabrutinib profile covers how it works, side effects in plain language, and its trial history.
What each outcome would mean
An approval starts a second race rather than ending the first one: specialty pharmacy setup, insurance review, and patient assistance typically take weeks even when everything goes right. Our guide to the 90 days after a rare disease approval explains the timeline and the moves families can make on day 1.
A complete response letter would mean the FDA declined to approve in the application's current form. CRLs are often about manufacturing or data presentation rather than efficacy, and resubmission is common. Either way, this page updates with the outcome and what it means.
Get notified when new primary-cns-lymphoma trials open or existing trials change status, add sites, or update eligibility.
Frequently asked questions
When will the FDA decide on Tirabrutinib?
The FDA's target decision date (PDUFA date) for Tirabrutinib in Relapsed/refractory primary CNS lymphoma is December 18, 2026, disclosed by Deciphera Pharmaceuticals. The agency can act before this date and occasionally runs past it.
What is Tirabrutinib being reviewed for?
Deciphera Pharmaceuticals submitted a NDA for Tirabrutinib in Relapsed/refractory primary CNS lymphoma. BTK inhibitor already approved in Japan for this rare brain lymphoma.
What happens after the Tirabrutinib decision?
If approved, availability is not immediate: specialty pharmacy setup, insurance review, and patient assistance typically take weeks even when everything goes right. If the FDA issues a complete response letter, the application was not approved in its current form; CRLs are often about manufacturing or data presentation rather than efficacy, and sponsors frequently resubmit. This page updates with the outcome either way.
Where this date comes from
The FDA does not publish PDUFA dates; companies disclose them. This one comes from Deciphera announcement. Dates can move, and the FDA can act early or late. This page rechecks against our calendar, which is re-verified daily.