Tags : Chronic Lymphocytic Leukaemia

Pharma Regulatory

AstraZeneca’s Calquence (acalabrutinib) Receives the US FDA’s Breakthrough Therapy Designation

Shots: The FDA’s BT Designation is based on the P-III ELEVATE-TN assessing Calquence (100 mg, bid) as monothx or in combination with obinutuzumab vs chlorambucil + obinutuzumab and in 535 patients in ratio (1:1:1) in previously untreated patients with CLL and in another P-III ASCEND Trial (ACE-CL-309) involves assessing of Calquence (310 mg) vs rituximab […]Read More

Pharma Regulatory

Janssen’s Imbruvica (ibrutinib) Receives CHMP Positive Recommendation for its Expanded

Shots: The CHMP’s positive opinion for CLL is based on P-III iLLUMINATE (PCYC1130) study assessing Imbruvica + obinutuzumab vs chlorambucil + obinutuzumab in patients with newly diagnosed CLL, resulted in longer m-PFS The CHMP’s positive opinion for WM is based on P-III iNNOVATE (PCYC-1127) study evaluating the ibrutinib & rituximab vs rituximab + PBO in […]Read More

Pharma

Roche Reports Results of Venclexta/Venclyxto (venetoclax) in P-III CLL14 Study

Shots: The P-III CLL14 Study involves assessing of Venclexta/Venclyxto + Gazyva/Gazyvar vs Gazyva/Gazyvaro + chlorambucil in 432 patients with previously untreated chronic lymphocytic leukemia (CLL) P-III CLL14 Study results: ORR (84.7% vs 71.3%); CR (49.5% vs 23.1%); patients receiving Venclexta/Venclyxto lived longer; disease progression @2yrs. (88.2% vs 64.1%); no new safety signals observed Venclexta/Venclyxto is […]Read More