3. Find a monoclonal antibody drug newly approved by the FDA in 2014-2016 (excep

Question

3. Find a monoclonal antibody drug newly approved by the FDA in 2014-2016 (except Opdivo). (12 points total) .State the antibody's commercial and chemical names. For example, Opdivo's chemical name is nivolumab. (2 points) .State the manufacturer and/or distributor's name. (1 points) .State the disease(s) or condition(s) that the antibody is used to treat. (1 point) Explain in full the antigen that the antibody recognizes. (2 points) Is the antibody binding to the antigen monovalent, bivalent, or multivalent? (2 points) . Is the drug PK best described by an IV bolus model, a steady state model, or some other model? (2 points) State the drug's apparent volume, also known as apparent distribution volume or sometimes as steady-state volume. (2 points)

Explanation / Answer

3) I am giving details about the monoclonal antibody Daratumumab approved by the FDA in the year 2015.

Chemical name - Daratumumab

Commercial name - Darzalex

Manufacturer name - Janssen - Cilag

Used to treat - multiple myeloma

The antibody recognises the antigen CD38

The antibody binding to the antigen is monovalent

The drug is given as an IV bolus

The distribution volume of Daratumumab is 4.7 liters.

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