FDA Approves ALIQOPA®, a PI3K Inhibitor, for Follicular Lymphoma

October 28th, 2017

The FDA in September 2017, granted accelerated approval to ALIQOPA® (Copanlisib) for the treatment of adult patients with relapsed Follicular Lymphoma, who have received at least two prior systemic therapies. Follicular Lymphoma is the most indolent form and second most common form of all Non Hodgkin Lymphomas and approximately 30% of the patients will relapse in 3 years following initial treatment. ALIQOPA® is a pan-class 1, PI3K inhibitor with inhibitory activity predominantly against PI3K-α and PI3K-δ Isoforms expressed in malignant B cells. ALIQOPA® has significant activity in patients with relapsed/refractory indolent B-cell lymphoma, and the safety was manageable, compared with other PI3K inhibitors.

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.

ZYDELIG® – A New Treatment Option for Non-Hodgkin Lymphoma

August 24th, 2014

The FDA granted ZYDELIG®, accelerated approval in relapsed Follicular B-cell Non-Hodgkin Lymphoma and Small Lymphocytic Lymphoma. The approval was based on ZYDELIG®’s significant single agent activity with an acceptable safety profile, in heavily pretreated patients with indolent Non Hodgkin Lymphomas. ZYDELIG® is a highly selective, small molecule, oral inhibitor of the enzyme Phosphoinositide 3-Kinase delta (PI3K delta) and blocks the delta isoform of PI3K enzyme and its signaling pathway, thus promoting apoptosis. More information is available at www.oncoprescribe.com

Brentuximab vedotin (SGN-35) for Hodgkin’s Lymphoma and Anaplastic large Cell Lymphoma

July 31st, 2011

Brentuximab vedotin (SGN-35) is an antibody-drug conjugate (ADC) that targets CD30, which is a protein  expressed on cancer cells in patients with Hodgkin’s lymphoma (HL) as well as Anaplastic Large Cell Lymphoma (ALCL), an aggressive type of T-cell non-Hodgkin’s lymphoma. This ADC consists of an anti-CD30 monoclonal antibody linked to monomethyl auristatin E (MMAE), an antimicrotubule agent. Upon binding to the CD30 molecule on the cancer cells, MMAE is released into the cancer cell resulting in cell death.

Taking advantage of this dual action, targeted mechanism of action of brentuximab vedotin , two phase II studies were conducted, one in patients with relapsed or refractory HL and the other in patients with relapsed or refractory systemic ALCL. In the HL pivotal trial, 102 relapsed or refractory Hodgkin lymphoma patients who had failed prior autologous stem cell transplant (ASCT) had an overall objective response rate of 75% and 34% of the patients went into complete remission (CR). In the second phase II trial, of the 58 patients with relapsed or refractory systemic ALCL, 86% achieved an objective response and 57% went into CR.

Based on these data, the Oncologic Drugs Advisory Committee (ODAC) voted 10-0 to recommend that the FDA grant accelerated approval of brentuximab vedotin. The results from the above two studies will change the treatment paradigm in this difficult to treat patient population.  

Maintenance Rituximab

February 2nd, 2011

The FDA on Jan 31, 2011 approved Rituximab as a maintenance treatment for patients with advanced follicular lymphoma, who responded to initial treatment with Rituximab plus chemotherapy. Follicular lymphomas are a subset of Non Hodgkins Lymphomas and are very responsive to chemotherapy or chemotherapy with Rituximab. They are usually incurable however, despite treatment with Rituximab plus chemotherapy. So think of this condition as a chronic disease. For this reason, prolonging remission duration is important, as the length of remission tends to be shorter with each recurrence.

In the PRIMA trial, which was a phase III study, maintenance Rituximab for 2 years given to those who responded to induction treatment with chemotherapy and Rituximab, delayed the risk of recurrence and improved progression free survival. These findings are relevant for patients who essentially have a chronic disease and are willing to pursue interventions that would delay recurrence of their lymphoma and therefore improve their quality of lives.