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25 Mar 2017

New mAB approval: Avelumab for metastatic Merkel Cell Carcinoma (mMCC)

Biomolecule: Avelumab
Brand : Bavencio
Class: Monoclonal Antibodies
Sub Class: Human anti-PD-L1 antibody of isotype IgG1
USFDA approval Date: 23rd March, 2017


Key Note: Bavencio, a human anti-PD-L1 antibody, is the first FDA-approved therapy for patients with mMCC.

EMD Serono, the biopharmaceutical business of Merck KGaA, Darmstadt, Germany in the US and Canada, and Pfizer has announced that the US Food and Drug Administration (FDA) has approved Bavencio (avelumab) Injection 20 mg/mL, for intravenous use, for the treatment of adults and pediatric patients 12 years and older with metastatic Merkel Cell Carcinoma (mMCC).

This indication is approved under accelerated approval based on tumor response and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. Bavencio was developed, reviewed and approved through the FDA’s Breakthrough Therapy Designation and Priority Review programmes.

Mechansim of Action

Avelumab binds to the PD ligand 1 and therefore inhibits binding to its receptor programmed cell death 1 (PD-1). Formation of a PD-1/PD-L1 receptor/ligand complex leads to inhibition of CD8+ T cells, and therefore inhibition of an immune reaction. Immunotherapy aims at ceasing this immune blockage by blocking those receptor ligand pairs. In the case of avelumab, the formation of PD-1/PDL1 ligand pairs is blocked and CD8+ T cell immune response should be increased. PD-1 itself has also been a target for immunotherapy. Therefore, avelumab belongs to the group of Immune checkpoint blockade cancer therapies.

Clinical Trial : Merkel-cell carcinoma

On March 23, 2017, the U.S. Food and Drug Administration granted accelerated approval to avelumab (BAVENCIO, EMD Serono, Inc.) for the treatment of adults and pediatric patients 12 years and older with metastatic Merkel cell carcinoma (MCC).

Approval was based on data from an open-label, single-arm, multi-center clinical trial (JAVELIN Merkel 200 trial) demonstrating a clinically meaningful and durable overall response rate (ORR). All patients had histologically confirmed metastatic MCC with disease progression on or after chemotherapy administered for metastatic disease.

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