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Abbvie
NEWS

AbbVie Reports the US FDA’s sNDA Submission of Venclexta + Acalabrutinib for Chronic Lymphocytic Leukemia

Shots: The US FDA has received sNDA of Venclexta (venetoclax) & acalabrutinib in previously untreated patients with chronic lymphocytic leukemia (CLL) sNDA was supported by AstraZeneca-sponsored P-III (AMPLIFY) trial assessing Venclexta + acalabrutinib ± Obinutuzumab vs chemoimmunotherapy in previously untreated CLL pts without del(17p) or TP53 mutation Trial showed that Venclexta + acalabrutinib a 35% reduction…
July 31, 2025

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Eli lilly
NEWS

Eli Lilly Reports Topline P-III (BRUIN CLL-314) Trial Results of Jaypirca (Pirtobrutinib) to Treat CLL/SLL

Shots: The P-III (BRUIN CLL-314) trial assessed Jaypirca vs Imbruvica in 650 pts with treatment-naïve or experienced (but BTK-naïve) chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) Trial met its 1EP of ORR non-inferiority in both pre-treated & ITT pts, with ORR favoring Jaypirca; PFS was immature but showed favorable trend, especially in treatment-naïve pts…
July 30, 2025

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NEWS

Ascentage Pharma Reports the NMPA’s Conditional Approval of Lisaftoclax for the Treatment of CLL/SLL

Shots: China’s NMPA has granted conditional approval to lisaftoclax for treating adults with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) who have previously received ≥1 systemic therapy incl. BTK inhibitors Approval was based on pivotal P-II (APG2575CC201) trial assessing lisaftoclax monotx. in r/r CLL/SLL pts previously treated with BTK inhibitors &/or immunochemotherapy, which met its 1EP of improved…
July 14, 2025

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New Drug Designations - November 2023
INSIGHTS+

New Drug Designations – November 2023

Shots:  PharmaShots' designation report provides a concise overview of several drugs and their designations by the US FDA, EMA and China. This month’s report includes 3 biological drugs, 12 small molecules, 13 cell and gene therapies, 1 peptide, 3 exosome-based therapy and 4 devices  Atsena Therapeutics’ capsid AAV.SPR gene therapy, focused on the treatment of Leber congenital…
December 27, 2023

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PharmaShots Interview Janssen’s Mark Wildgust Shares Insights on Imbruvica for Chronic Lymphocytic Leukemia and Darzalex for Multiple Myeloma
VIEWPOINTS

PharmaShots Interview: Janssen’s Mark Wildgust Shares Insights on Imbruvica for Chronic Lymphocytic Leukemia and Darzalex for Multiple Myeloma

In an interview with PharmaShots, Mark Wildgust, Vice President, Global Medical Affairs, Oncology at Janssen shared his views on the data of Imbruvica in P-III (GLOW) and P-II (CAPTIVATE) studies for the treatment of CLL or SLL and also highlighted the results of Darzalex in the P-II (GRIFFIN) & P-III (MAIA) study for multiple myeloma The P-III (GLOW) and P-II (CAPTIVATE) studies evaluating Imbruvica + venetoclax (I+V) as a…
May 2, 2022

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