FDA Approves Subcutaneous RITUXAN® Formulation for CD20-Positive Hematologic Malignancies

July 6th, 2017

The US FDA on June 22, 2017, granted regular approval to the combination of RITUXAN® (Rituximab) and Hyaluronidase human (RITUXAN HYCELA®) for adult patients with Follicular Lymphoma, Diffuse Large B-Cell Lymphoma, and Chronic Lymphocytic Leukemia. This Subcutaneous formulation of RITUXAN® utilizes ENHANZE®, a drug delivery technology platform, which removes limitations on the volume of biologics and drugs that can be delivered Subcutaneously, thereby significantly reducing the time required for drug administration. The approval of RITUXAN HYCELA® was based on several randomized clinical trials that demonstrated Non-inferior pharmacokinetics of Subcutaneous RITUXAN HYCELA® compared with IV RITUXAN®, as well as comparable efficacy and safety results.

ARZERRA® combination for Frontline Treatment of CLL

April 27th, 2014

The FDA on April 17, 2014 approved ARZERRA® (Ofatumumab) in combination with LEUKERAN® (Chlorambucil), for the treatment of previously untreated patients with Chronic Lymphocytic Leukemia (CLL), for whom FLUDARA® (Fludarabine) based therapy is considered inappropriate. ARZERRA® is a second generation fully human IgG 1 monoclonal antibody and unlike RITUXAN® (Rituximab) which is a chimeric monoclonal antibody, targets a different region (different epitope) of the CD20 molecule. The combination of ARZERRA® given along with LEUKERAN® significantly improved Progression Free Survival, Response Rates and duration of response, compared to single agent LEUKERAN®. ARZERRA®  in combination with LEUKERAN®  is a clinically important milestone, in the management of elderly patients with CLL.

GAZYVA® plus LEUKERAN® – A new option for elderly patients with CLL

December 5th, 2013

Obinutuzumab or GAZYVA® (GA101) is glycoengineered, fully humanized, third generation, type II anti-CD20 antibody (IgG1 monoclonal antibody) that selectivity binds to the extracellular domain of the CD20 antigen on malignant human B cells. It has enhanced antibody-dependent cellular cytotoxicity (ADCC) and strong apoptosis-inducing activity. In contrast, RITUXAN® (Rituximab) is a first generation chimeric anti-CD20 targeted monoclonal antibody. In a phase III trial, a combination of GAZYVA® plus LEUKERAN® (Chlorambucil), significantly improved Progression Free Survival in elderly patients with CLL compared to RITUXAN® plus LEUKERAN®. This study gives new life to LEUKERAN® when given in combination with CD20 targeted monoclonal antibodies and may be of value when treating elderly patients with comorbid conditions. This data was presented at the 2013 ASCO meeting.

Aggressive Melanoma in patients with CLL

December 27th, 2010

It appears that patients with a history of Chronic Lymphocytic Leukemia (CLL) are at a higher risk of developing Malignant Melanoma. If they do develop this skin cancer, they tend to have more aggressive disease than their non-CLL counterparts, with a higher mortality rate. This may be related to genetic aberrations common to both CLL and Malignant Melanoma. They include genetic aberrations of P53 gene and proto-oncogene B-Cell Lymphoma- 2 (Bcl-2).

It is therefore important that patients with CLL be closely monitored for melanoma and take the necessary sun-protective measures. Further, even when diagnosed with early stage Malignant Melanoma, these individuals may need aggressive local intervention.

Oncoprescribe Blog: Just added Synopsis/Clinical Relevance for ARZERRA for CLL

January 16th, 2010

We’ve just completed a write up for ARZERRA for CLL, including a recap of the research presented at ASCO 2009 by Kipps, T. et al.

In a nutshell, here are the findings:

*The authors concluded that single agent therapy with Ofatumumab (ARZERRA®) acheives a high overall response rate and improves disease symptoms as well as hematologic parameters in heavily pretreated CLL patients presenting with double refractory and bulky Fludarabine orefractory disease, irrespective of prior therapy with Rituximab.*u

To view the entire Synopsis and Clinical Relevance, log on to www.oncoprescribe.com – if aren’t registered yet; the subscription is free.