Breyanzi (liso cel): Orphan designation withdrawal for all 3 indications (DLBCL, FL, PMBCL)
BMS withdrew all three orphan designations for Breyanzi prior to COMP final opinion (Treatment of diffuse large B-cell lymphoma, Treatment of follicular lymphoma, Treatment of primary mediastinal large-B-cell lymphoma), apparently due to the following COMP request they could not address:
- The sponsor is invited to further elaborate on the indirect comparison regarding better safety to Yescarta.
For Yescarta (where improved safety and comparable efficacy was the claim): The COMP noted that regarding their claim of improved safety for DLBCL versus Yescarta, the relevance of the quantitative difference of the adverse events should be further discussed in view of the high risk of selective reporting of safety outcomes noted and the general challenges when performing an indirect comparison based on results from single-arm trials. The methods used for the MAIC should be further clarified .
For Kymriah (where improved efficacy and safety was the claim): In conclusion, the sponsor claims improved efficacy of Breyanzi versus Kymriah. The methods for indirect comparison, are not presented with sufficient details. The analysis was performed only for the full patient dataset, even though the proportion of patients who received prior bridging therapy differs significantly (which was considered a relevant aspect in the SB discussion over Yescarta). The COMP therefore invites the sponsor to compare only the patient subsets who received prior bridging therapy, in a similar manner to that described in the significant benefit discussion versus Yescarta. The methods used for the MAIC should be further clarified.