The study find that the combination with rituximab for previously treated follicular lymphoma (FL) and previously treat marginal zone lymphoma (MZL); both of which are also know as indolent non-Hodgkin lymphomas. non-Hodgkin lymphoma (NHL) expect to be diagnose in 2019 in the United States; approximately 20% are likely to be follicular lymphomas.

Rituximab for previously treated

No sex preponderance is see for follicular lymphomas, but the incidence increases with age and varies across racial groups. See the image below. Follicular lymphoma is a type of non-Hodgkin lymphoma that most commonly presents as a painless; slowly progressive adenopathy. Systemic symptoms, such as fever, drenching night sweats; or weight loss in excess of 10% of ideal body weight; or asthenia, are infrequent at presentation but can be observe in later stages of the disease.

Symptoms related to bone marrow dysfunction, such as anemia, leukopenia, or thrombocytopenia; are rare at presentation but can also be observed in the later stages of the disease. Lymphocytosis; reflecting blood involvement, may also be present. The agency said the combo, which has been called Len-R; is approve on the basis of two clinical trials, AUGMENT and MAGNIFY.

Bone marrow dysfunction

In AUGMENT; 358 patients with relapsed or refractory FL or MZL are randomly assign (1:1) to receive lenalidomide and rituximab (up to 12 cycles) or rituximab and placebo (5 cycles). For the study’s primary endpoint of progression-free survival (PFS); the median PFS was 39.4 months in the lenalidomide group and 14.1 months in the placebo group (hazard ratio, 0.46; 95% confidence interval; 0.34 – 0.62; P < .0001).

The objective response rate (ORR) for patients with FL was 80% in the lenalidomide group compared with 55.4% in the placebo group. For patients with MZL, the ORR was 65% compared with 44%, respectively. In the single-group component of MAGNIFY, 232 patients with relapsed or refractory FL, MZL, or mantle-cell lymphoma received 12 induction cycles of lenalidomide and rituximab.

The prescribing information

In MAGNIFY, for patients with FL, the ORR was 59%. Median response duration is not reach, with a median follow-up of 7.9 months. For patients with MZL, the ORR was 51%. Median response duration was also not reached, with a median follow-up of 11.5 months.

Across the two trials, adverse reactions occurring in at least 20% of patients were neutropenia, fatigue, diarrhea, constipation, nausea, and cough. The FDA pointed out that the prescribing information includes a boxed warning about the risk for embryo-fetal toxicity, hematologic toxicity, and venous and arterial thromboembolism, which may be life-threatening or fatal. The recommended lenalidomide dose for FL or MZL is 20 mg once daily, orally; on days 1-21 of repeated 28-day cycles for up to 12 cycles. The FDA granted this application through priority review and after designating it as an orphan drug.