Maria Babak, Head of The Babak Lab and Assistant Professor at City University of Hong Kong, shared The Babak Lab’s on LinkedIn, adding:
“Fantastic news… and high ORR and CR present encouraging signal for earlier line use!”
Quoting The Babak Lab’s post:
“Tecartus in mantle cell lymphoma
The FDA has granted full approval to Tecartus (brexucabtagene autoleucel) for adult patients with relapsed or refractory mantle cell lymphoma. Mantle cell lymphoma (MCL) is a rare form of non-Hodgkin lymphoma (NHL) that arises from cells originating in the ՛mantle zone՛ of the lymph node and predominantly affects men over the age of 60.
Key Focus
Tecartus is a CD19-directed CAR-T cell therapy designed to reprogram a patient’s own T cells to recognize and eliminate malignant B cells.
Key Insights
- Full approval is based on updated data from the ZUMA-2 trial
- In cohort 1 (BTKi-exposed), Tecartus demonstrated an overall response rate (ORR) of 87% and a complete remission (CR) rate of 62%
- In cohort 3 (BTKi-naive), the therapy showed an ORR of 91% and a CR rate of 79%
- Median duration of response was not reached in both cohorts
- This approval supports Tecartus use in earlier line settings
- Conclusion
This approval reinforces the role of CAR-T therapies in hematologic malignancies and supports broader integration of Tecartus into clinical practice.
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