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Darzalex Faspro (daratumumab-and-hyaluronidase-fihj)

Pfizer · FDA-approved active Monoclonal antibody Quality 63/100

Darzalex Faspro (generic name: daratumumab-and-hyaluronidase-fihj) is a CD38-directed Cytolytic Antibody [EPC] Monoclonal antibody drug developed by Pfizer. It is currently FDA-approved (first approved 2020) for Multiple Myeloma - Induction/Consolidation, Multiple Myeloma - Ineligible for Transplant, Multiple Myeloma - Melphalan/Prednisone.

Daratumumab and Hyaluronidase-fihj is a monoclonal antibody that targets CD38, a transmembrane glycoprotein on the surface of hematopoietic cells.

Daratumumab and Hyaluronidase-fihj, developed by Pfizer Inc., is a monoclonal antibody that targets CD38, a transmembrane glycoprotein on the surface of hematopoietic cells. It works by inducing apoptosis and immune-mediated tumor cell lysis. The drug is used to treat multiple myeloma in combination with other therapies. Its clinical differentiation lies in its ability to target CD38, a novel approach in multiple myeloma treatment. The commercial significance of Daratumumab and Hyaluronidase-fihj is its approval for multiple indications, including newly diagnosed patients and those with relapsed or refractory disease. Pipeline developments are not mentioned. The drug's mechanism of action is a key factor in its clinical differentiation and commercial significance.

At a glance

Generic namedaratumumab-and-hyaluronidase-fihj
SponsorPfizer
Drug classCD38-directed Cytolytic Antibody [EPC]
TargetCD38
ModalityMonoclonal antibody
Therapeutic areaOncology
PhaseFDA-approved
First approval2020

Mechanism of action

Daratumumab is an IgG1κ human monoclonal antibody that binds to CD38 and inhibits the growth of CD38 expressing tumor cells. It induces apoptosis directly through Fc mediated cross linking as well as by immune-mediated tumor cell lysis through complement dependent cytotoxicity (CDC), antibody dependent cell mediated cytotoxicity (ADCC) and antibody dependent cellular phagocytosis (ADCP). A subset of myeloid derived suppressor cells (CD38+MDSCs), regulatory T cells (CD38+T regs ) and B cells (CD38+B regs ) are decreased by daratumumab.

Approved indications

Common side effects

Drug interactions

Key clinical trials

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

SourceUsed for
FDA labelMechanism, indications, dosing, boxed warnings, drug interactions
ClinicalTrials.govTrial enrolment, design, endpoints, results

Competitive intelligence

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Frequently asked questions about Darzalex Faspro

What is Darzalex Faspro?

Darzalex Faspro (daratumumab-and-hyaluronidase-fihj) is a CD38-directed Cytolytic Antibody [EPC] drug developed by Pfizer, indicated for Multiple Myeloma - Induction/Consolidation, Multiple Myeloma - Ineligible for Transplant, Multiple Myeloma - Melphalan/Prednisone.

How does Darzalex Faspro work?

Daratumumab and Hyaluronidase-fihj is a monoclonal antibody that targets CD38, a transmembrane glycoprotein on the surface of hematopoietic cells.

What is Darzalex Faspro used for?

Darzalex Faspro is indicated for Multiple Myeloma - Induction/Consolidation, Multiple Myeloma - Ineligible for Transplant, Multiple Myeloma - Melphalan/Prednisone, Multiple Myeloma - Lenalidomide/Dexamethasone, Multiple Myeloma - Thalidomide.

Who makes Darzalex Faspro?

Darzalex Faspro is developed and marketed by Pfizer (see full Pfizer pipeline at /company/pfizer).

What is the generic name of Darzalex Faspro?

daratumumab-and-hyaluronidase-fihj is the generic (nonproprietary) name of Darzalex Faspro.

What drug class is Darzalex Faspro in?

Darzalex Faspro belongs to the CD38-directed Cytolytic Antibody [EPC] class. See all CD38-directed Cytolytic Antibody [EPC] drugs at /class/cd38-directed-cytolytic-antibody-epc.

When was Darzalex Faspro approved?

Darzalex Faspro was first approved on 2020.

What development phase is Darzalex Faspro in?

Darzalex Faspro is FDA-approved (marketed).

What are the side effects of Darzalex Faspro?

Common side effects of Darzalex Faspro include Peripheral neuropathy, Paresthesia, Fatigue, Edema, Pyrexia, Upper respiratory tract infection.

What does Darzalex Faspro target?

Darzalex Faspro targets CD38 and is a CD38-directed Cytolytic Antibody [EPC].

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