Obinutuzumab
Intravenous obinutuzumab (Gazyva) may be considered medically necessary to treat patients with NHL for the following FDA labeled indications:
Follicular lymphoma (FL):
· In combination with chemotherapy followed by obinutuzumab monotherapy in patients achieving at least a partial remission, is indicated for the treatment of adult patients with previously untreated stage II bulky, III or IV FL.
· In combination with bendamustine followed by obinutuzumab monotherapy, for the treatment of patients with FL who relapsed after, or are refractory to, a rituximab-containing regimen.
Chronic lymphocytic leukemia (CLL):
· In combination with chlorambucil, for the treatment of patients with previously untreated CLL.
Obinutuzumab (Gazyva) is considered investigational for relapsed or refractory CLL.
CLL is considered to be identical (ie, one disease with different manifestations) to the mature (peripheral) B cell neoplasm small lymphocytic lymphoma (SLL), one of the indolent non-Hodgkin lymphomas. The term CLL is used when the disease manifests primarily in the bone marrow and blood while the term SLL is used when involvement is primarily nodal.
«Follicular Lymphoma (grade 1-2)
– First-line therapy for stage I, contiguous stage II, non-contiguous stage II disease, or for patients with indications for treatment with stage III or IV disease preferred in combination with bendamustine, CHOP (cyclophosphamide, doxorubicin, vincristine, and prednisone) or CVP (cyclophosphamide, vincristine, and prednisone) regimens in combination with lenalidomide. Second-line and subsequent therapy (if not previously given) for no response, relapsed, or progressive disease in patients with indications for treatment preferred* in combination with bendamustine, CHOP (cyclophosphamide, doxorubicin, vincristine, and prednisone) or CVP (cyclophosphamide, vincristine, and prednisone) regimen as a single agent or in combination with lenalidomide
*obinutuzumab is preferred in rituximab refractory patients, which includes disease progressing on or within 6 months of prior rituximab therapy. Single-agent maintenance therapy preferred as optional first-line consolidation or extended dosing following chemoimmunotherapy preferred as optional second-line consolidation or extended dosing for rituximab-refractory disease»
«Gastric MALT Lymphoma
-Second-line and subsequent therapy for relapsed, refractory, or progressive disease in patients with indications for treatment preferred in combination with bendamustine (not recommended if previously
treated with bendamustine) as a component of CHOP (cyclophosphamide, doxorubicin, vincristine, and prednisone) with obinutuzumab regimen as a component of CVP (cyclophosphamide, vincristine, and prednisone with obinutuzumab regimen in combination with lenalidomide»
«Nongastric MALT Lymphoma (Noncutaneous)
-Second-line and subsequent therapy for relapsed, refractory, or progressive disease in patients with indications for treatment preferred in combination with bendamustine (not recommended if previously
treated with bendamustine) as a component of CHOP (cyclophosphamide, doxorubicin, vincristine, and
prednisone) with obinutuzumab regimen as a component of CVP (cyclophosphamide, vincristine, and prednisone) with obinutuzumab regimen in combination with lenalidomide»
«Nodal Marginal Zone Lymphoma
-First-line therapy for stage I, contiguous stage II, non-contiguous stage II, or stage III, IV disease in patients with indications for treatment in combination with bendamustine (preferred) as a component of CHOP (cyclophosphamide, doxorubicin, vincristine, and prednisone) with obinutuzumab regimen as a component of CVP (cyclophosphamide, vincristine, and prednisone) with obinutuzumab regimen»
«Splenic Marginal Zone Lymphoma
-Second-line therapy for disease recurrence following initial management of splenomegaly (if previously treated with rituximab) and subsequent therapy in patients with indications for treatment preferred in combination with bendamustine (not recommended if previously treated with bendamustine)
as a component of CHOP (cyclophosphamide, doxorubicin, vincristine, and prednisone) with obinutuzumab regimen as a component of CVP (cyclophosphamide, vincristine, and prednisone) with
obinutuzumab regimen in combination with lenalidomide»
«Mantle Cell Lymphoma
-Used as a substitute* for rituximab in patients with intolerance (including those experiencing severe hypersensitivity reactions requiring discontinuation of rituximab) as well as rare complications such as mucocutaneous reactions including paraneoplastic pemphigus, Stevens-Johnson syndrome, lichenoid dermatitis, vesiculobullous dermatitis, and toxic epidermal necrolysis»
«Diffuse Large B-Cell Lymphoma
-Used as a substitute* for rituximab in patients with intolerance (including those experiencing severe hypersensitivity reactions requiring discontinuation of rituximab) as well as rare complications such as mucocutaneous reactions including paraneoplastic pemphigus, Stevens-Johnson syndrome, lichenoid dermatitis, vesiculobullous dermatitis, and toxic epidermal necrolysis »
«Histologic Transformation of Indolent Lymphomas to Diffuse Large B-Cell Lymphoma
-Used as a substitute* for rituximab in patients with intolerance (including those experiencing severe hypersensitivity reactions requiring discontinuation of rituximab) as well as rare complications such as mucocutaneous reactions including paraneoplastic pemphigus, Stevens-Johnson syndrome, lichenoid dermatitis, vesiculobullous dermatitis, and toxic epidermal necrolysis »
«High-Grade B-Cell Lymphomas
-Used as a substitute* for rituximab in patients with intolerance (including those experiencing severe hypersensitivity reactions requiring discontinuation of rituximab) as well as rare complications such as mucocutaneous reactions including paraneoplastic pemphigus, Stevens-Johnson syndrome, lichenoid dermatitis, vesiculobullous dermatitis, and toxic epidermal necrolysis »
«Burkitt Lymphoma
-Used as a substitute* for rituximab in patients with intolerance (including those experiencing severe hypersensitivity reactions requiring discontinuation of rituximab) as well as rare complications such as mucocutaneous reactions including paraneoplastic pemphigus, Stevens-Johnson syndrome, lichenoid dermatitis, vesiculobullous dermatitis, and toxic epidermal necrolysis »
«AIDS-Related B-Cell Lymphomas
-Used as a substitute* for rituximab in patients with intolerance (including those experiencing severe hypersensitivity reactions requiring discontinuation of rituximab) as well as rare complications such as mucocutaneous reactions including paraneoplastic pemphigus, Stevens-Johnson syndrome, lichenoid dermatitis, vesiculobullous dermatitis, and toxic epidermal necrolysis»
«Post-Transplant Lymphoproliferative Disorders
-Used as a substitute* for rituximab in patients with intolerance (including those experiencing severe hypersensitivity reactions requiring discontinuation of rituximab) as well as rare complications such as mucocutaneous reactions including paraneoplastic pemphigus, Stevens-Johnson syndrome, lichenoid dermatitis,vesiculobullous dermatitis, and toxic epidermal necrolysis»
«Castleman Disease
-Used as a substitute* for rituximab in patients with intolerance (including those experiencing severe hypersensitivity reactions requiring discontinuation of rituximab) as well as rare complications such as mucocutaneous reactions including paraneoplastic pemphigus, Stevens-Johnson syndrome, lichenoid dermatitis, vesiculobullous dermatitis, and toxic epidermal necrolysis »
«Hairy Cell Leukemia
-Consider in combination with vemurafenib as initial therapy for patients with indications for treatment who are unable to tolerate purine analogs including frail patients and those with active infection (useful in certain circumstances)»
«Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
-First-line therapy for CLL/SLL without del(17p)/TP53 mutation in patients who have indications for treatment in combination with acalabrutinib (preferred) in combination with ibrutinib* *recommended only in patients ≥65 years of age and younger patients with significant comorbidities (creatinine clearance <70 mL/min) "
