The US FDA Grants Fast Track Designation to Dizal’s Birelentinib for Treating R/R CLL/SLL

Shots:The US FDA has granted FTD to Birelentinib (DZD8586) for the treatment of adults with r/r chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) who have received ≥2L of therapy, incl. a BTK & a BCL-2 inhibitorDesignation was based on pooled P-I/II data showing 84.2% ORR & DoR rate of 83.3% at 9mos.…

ByRidhi RastogiAugust 8, 2025

NEWS

Dizal Receives the US FDA’s Accelerated Approval for Zegfrovy (Sunvozertinib) to Treat EGFRm NSCLC

Shots:The US FDA has granted accelerated approval to Zegfrovy for locally advanced or metastatic NSCLC associated with EGFR exon 20 insertion mutations (exon20ins) in pts whose disease has progressed on or after Pt-based CTApproval was based on the multinational WU-KONG1 part B trial assessing Zegfrovy in above mentioned pts, which showed significant improvement…

ByRidhi RastogiJuly 3, 2025

NEWS

Dizal Reports Enrollment Completion in P-III (WU-KONG28) Trial of Sunvozertinib for EGFRm NSCLC

Shots:Dizal has completed pts enrollment in P-III (WU-KONG28) trial of sunvozertinib as a 1L treatment of NSCLC harboring EGFR exon 20 insertion mutations (exon20ins); NDA under the US FDA’s priority review (PDUFA: Jul 7, 2025)Trial assessed sunvozertinib vs Pt-based doublet CTs in treatment-naïve NSCLC pts with EGFR exon20ins across 16 countries & regions…

ByRidhi RastogiJune 20, 2025

The US FDA Grants Fast Track Designation to Dizal’s Birelentinib for Treating R/R CLL/SLL

Dizal Receives the US FDA’s Accelerated Approval for Zegfrovy (Sunvozertinib) to Treat EGFRm NSCLC

Dizal Reports Enrollment Completion in P-III (WU-KONG28) Trial of Sunvozertinib for EGFRm NSCLC

Contact US

OUR INFORMATION

FOLLOW US