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The US FDA has approved an additional indication for Jaypirca (pirtobrutinib, 100 & 50mg) for the treatment of adults with previously untreated chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) with no known 17p deletion
Approval was based on the P-III (BRUIN CLL-313) trial data P-III assessing Jaypirca (200mg, PO, QD until disease progression or unacceptable toxicity) vs chemoimmunotherapyin 282 treatment-naïve CLL/SLL pts without 17p deletions
At mFU of 28mos., trial showed improvement in IRC-assessed PFS (1EP) with the mPFS not reached for pirtobrutinib vs 33.5mos. Plus, ORR was 94% vs 81% (CR: 13% vs 21%, PR: 81% vs 60%); data were published in The JCO
Ref: Eli Lilly | Image: Eli Lilly | Press Release
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The post The US FDA Approves Eli Lilly’s Jaypirca (Pirtobrutinib) for Certain Patients with Previously Untreated CLL/SLL appeared first on PharmaShots.
The US FDA Approves Eli Lilly’s Jaypirca (Pirtobrutinib) for Certain Patients with Previously Untreated CLL/SLL | PharmaVoice