Shots: The approval is based on P-III E1912 study assessing Imbruvica + rituximab (IR) followed by ibrutinib until disease progression or unacceptable toxicity, or six cycles of FCR in 529 […]readmore
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 […]readmore
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 […]readmore
Shots: The P-III ASCEND study results involve assessing of Calquence as monothx. (100mg, bid) vs Rituximab + Idelalisib (IdR) or Bendamustine (BR) in 310 patients in a ratio (1:1) with […]readmore
Shots: The P-III ELEVATE-TN trial involves assessing of Calquence (100 mg bid) as monothx and + obinutuzumab vs chlorambucil + obinutuzumab in 535 patients in ratio (1:1:1) with previously untreated […]readmore
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 […]readmore
Shots: The P-III ASCEND study involves assessing of Calquence (acalabrutinib, 100mg, q2d) vs Rituximab + Idelalisib/Bendamustine in 310 previously treated patients in a ratio (1:1) with CLL The P-III ASCEND […]readmore