Tags : Imbruvica

Clinical Trials

Janssen Reports Long-Term Benefits of Imbruvica (ibrutinib) as 1L Treatment

Shots: Janssen reported pooled analyses of long-term follow-up from multiple clinical trials evaluating the use of Imbruvica monothx. and in combination as a 1L treatment for patients with CLL with high-risk features Results from an integrated analysis of two clinical trials with ~79mos. of follow-up demonstrated PFS rates (63%-82%) @42mos.; median duration of treatment across […]Read More

Top 20

Top 20 Prescription Drugs Based on 2019 Revenue

The average life expectancy span of Human Beings are increased due to better medical facilities and drugs developed by Biopharma companies. Pharmaceutical products or drugs or medicines are being produced for a wide range of medical sectors. It includes the lifesaving drugs or the major therapy area including immunology, cardiology, and neurology but are they […]Read More

Regulatory

Janssen’s Imbruvica (ibrutinib) Receives European Commission Approval for Chronic Lymphocytic

Shots: The approval is based on P-III iLLUMINATE (PCYC-1130) and P-III iNNOVATE (PCYC-1127) study assessing Imbruvica + obinutuzumab vs chlorambucil + obinutuzumab and Imbruvica + rituximab vs rituximab + PBO in patients with previously untreated CLL and r/r WM respectively Collective results: improvement in PFS with the use of ibrutinib-based therapy vs SOC providing CT […]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

Regulatory

AbbVie’s Imbruvica (ibrutinib) + Gazyva (obinutuzumab) Receives FDA’s Approval, First

Shots: The combinational approval is based P-III iLLUMANTE (PCYC-1130) study results assessing Imbruvica + Gazyva vs chlorambucil + Gazyva in patients with 1L+ Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL) aged ≥ 65 years The P-III iLLUMANTE study resulted in 77% reduction in risk of progression or death and has also shown 85% reduction in progression […]Read More