FDA Approvals – November 2021

Several indications and molecules were approved in November by FDA including the following:

1- Pembrolizumab for the adjuvant treatment of adult and pediatric (≥12 years of age) patients with stage IIB or IIC melanoma following complete resection.

2- Rituximab in combination with chemotherapy for pediatric patients (≥6 months to <18 years) with previously untreated, advanced stage, CD20-positive diffuse large B-cell lymphoma (DLBCL), Burkitt lymphoma (BL), Burkitt-like lymphoma (BLL), or mature B-cell acute leukemia (B-AL).

3- Daratumumab + hyaluronidase-fihj and carfilzomib plus dexamethasone foradult patients with relapsed or refractory multiple myeloma who have received 1 to 3 prior lines of therapy.

For October’s approvals, please click here.