Ozekibart (INBRX-109) for Unresectable or metastatic conventional chondrosarcoma
The FDA is expected to decide on Ozekibart for Unresectable or metastatic conventional chondrosarcoma by April 14, 2027, under a BLA from Inhibrx Biosciences.
What is being decided
Inhibrx Biosciences has a BLA under FDA review for Ozekibart (INBRX-109) in Unresectable or metastatic conventional chondrosarcoma. DR5 agonist antibody; would be the first approved systemic therapy for this rare bone cancer, which has no approved drug treatment today.
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.
Frequently asked questions
When will the FDA decide on Ozekibart?
The FDA's target date (PDUFA date) for Ozekibart in Unresectable or metastatic conventional chondrosarcoma is April 14, 2027.
Who disclosed it: Inhibrx Biosciences. The FDA does not publish these dates.
Can it move: the FDA can act early, and a major amendment to the application can push the date back 3 months.
Source: Inhibrx press release
What is Ozekibart being reviewed for?
Inhibrx Biosciences submitted a BLA for Ozekibart in Unresectable or metastatic conventional chondrosarcoma.
What to know: DR5 agonist antibody; would be the first approved systemic therapy for this rare bone cancer, which has no approved drug treatment today.
How much will Ozekibart cost?
Inhibrx Biosciences has not announced a price. Drugmakers usually set it around approval.
Help paying: drugmaker programs and charity funds usually open at launch.
Find help: the patient assistance finder lists programs by insurance type.
What happens after the Ozekibart decision?
This page updates with the outcome the day it is announced.
If approved: getting the drug still takes time. Specialty pharmacy setup, insurance review and patient assistance often take weeks. Our guide covers what families can do on day 1.
If not approved: a complete response letter means the FDA declined the application in its current form. Many are about manufacturing or how data were presented, and companies often resubmit.
Where this date comes from
The FDA does not publish PDUFA dates; companies disclose them. This one comes from Inhibrx press release. Dates can move, and the FDA can act early or late. This page rechecks against our calendar, which is re-verified daily.