Lymphoma

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Calquence (acalabrutinib) was granted an accelerated approval by the FDA to treat adult patients with mantle cell lymphoma (MCL) following at least one prior therapy. The approval was based on objective response rates (ORR) in a single-arm trial.

The Food and Drug Administration (FDA) granted a priority review to a supplemental biologics license application (sBLA) for Gazyva (obinutuzumab) to be used in combination with chemotherapy for first-line treatment of patients who have follicular lymphoma, according to Genentech, the manufacturer of the drug.

ClearLLab multicolor reagents (T1, T2, B1, B2, M) gained approval from the Food and Drug Administration (FDA) to detect chronic leukemia, acute leukemia, non-Hodgkin lymphoma, multiple myeloma, myelodysplastic syndrome (MDS) and myeloproliferative neoplasms (MPN). This is the first approval the agency received for immunophenotyping on a flow cytometer.

Rituxan Hycela (rituximab) was granted approval by the Food and Drug Administration (FDA) for adult patients with previously untreated and relapsed or refractory follicular lymphoma, previously untreated diffuse large B-cell lymphoma (DLBCL) and previously untreated and previously treated chronic lymphocytic leukemia (CLL).