Top Performing Drug of 2021 - Darzalex (March Edition)

Shots:

The ongoing series of the top-performing drugs of 2021 based on revenue is continued by Darzalex as the top-performing drug for March month
Darzalex is a CD38-directed cytolytic antibody indicated for the treatment of adult patients with multiple myeloma in combination with different drugs
The report summarizes the key features of Darzalex including revenue & clinical trials analysis, approved indications, drug interactions and patient support programs

Active Ingredient: Daratumumab

Dosage Forms & Strengths:

Injection: 100 mg/5 mL & 400 mg/20 mL solution in a single-dose vial

Mechanism of Action: IgG1k*CD38-directed ADC

First Approval: US (Nov 16, 2015), EU (May 20, 2016)

Revenue Analysis¹

Darzalex is an imperative product contributing to the rise of sales in the oncology portfolio of Johnson & Johnson. The portfolio sales grew 9.9% vs. 2021. The product growth was driven by share gains in all regions and continued strong market growth. In 2022, Darzalex’s revenue increased by 33% in the US and 32% worldwide.

Below mentioned is the revenue analysis of Darzalex for the past five years:

Approved Indications and Usage for Darzalex²

Darzalex is a CD38-directed cytolytic antibody indicated for the treatment of adult patients with multiple myeloma in combination with different drugs as follows:

• lenalidomide and dexamethasone in newly diagnosed patients who are ineligible for autologous stem cell transplant and in patients with r/r multiple myeloma who have received at least one prior therapy

• bortezomib, melphalan, and prednisone in newly diagnosed patients who are ineligible for autologous stem cell transplant

• thalidomide, and dexamethasone in newly diagnosed patients who are eligible for autologous stem cell transplant

• bortezomib and dexamethasone in patients who have received at least one prior therapy

• carfilzomib and dexamethasone in patients with r/r multiple myeloma who have received one to three prior lines of therapy

• pomalidomide and dexamethasone in patients who have received at least two prior therapies including lenalidomide and a proteasome inhibitor

• as monotherapy, in patients who have received at least three prior lines of therapy including a proteasome inhibitor (PI) and an immunomodulatory agent or who are double refractory to a PI and an immunomodulatory agent

Clinical Trials Analysis³

Darzalex has a total of 299 trials, incl. 209 industry trials of which 204 are interventional, 3 are observational, and 2 are expanded access trials. PharmaShots has prepared a graphical representation of Darzalex clinical trials which is showcased below. (Trials are taken as of 13 Mar 2023).

*Active trials include Recruiting; Active, Not Recruiting; Enrolling by Invitation, and suspended

*Inactive trials include Terminated; Withdrawn; Unknown Status

*Planned trials include Not, yet recruiting

Darzalex Pipeline Analysis

PharmaShots presents a thorough analysis of the Darzalex pipeline, including ongoing Phase II and Phase III registration studies for various indications. The table shown below is an overview of the status of these studies

Affordability Options for Darzalex⁴

Janssen CarePath can help patients find the resources they may need to help them get started on their Janssen medication. There may be options that make their treatment more affordable. Such as:

If the patients use commercial or private health insurance to pay for your Janssen medication

Eligible patients pay $5 per infusion. The program gives a $20,000 maximum program benefit per calendar year. There is no income requirement. Terms expire at the end of each calendar year and may change. See program requirements at Darzalex.JanssenCarePathSavings.com.

The patients can determine eligibility, enroll in the Savings Program, submit Savings Program requests, and manage program benefits, by creating an online account at MyJanssenCarePath.com.

If the patients use government-funded healthcare programs like Medicare or Medicaid

Janssen CarePath can refer patients to the Medicare Savings Program to discuss eligibility and program benefits. Many states have programs for people with limited income and resources that pay some or all of Medicare's premiums and may pay Medicare deductibles and co-insurance.

Independent co-pay assistance foundations

Independent co-pay assistance foundations have their own rules for eligibility, which are subject to change. Some of these foundations are:

Accessia Health
CancerCare
Good Days
HealthWell Foundation
Leukemia & Lymphoma Society (LLS)
Patient Access Network Foundation
Patient Advocate Foundation

Insured patients may be eligible for additional support from Janssen

Patient assistance from Janssen is available if patients have commercial, employer-sponsored, or government coverage that does not fully meet their needs. Patients may be eligible to receive Darzalex free of charge for up to one year. For that, the patients must meet the eligibility and income requirements for the patient assistance program through Johnson & Johnson Patient Assistance Foundation.

Darzalex Drug Interactions⁵

Effects of Daratumumab on Laboratory Tests

Interference with Indirect Antiglobulin Tests (Indirect Coombs Test)

Daratumumab binds to CD38 on RBCs and interferes with compatibility testing, including antibody screening and cross-matching. Daratumumab interference mitigation methods include treating reagent RBCs with dithiothreitol (DTT) to disrupt daratumumab binding or genotyping. Since the Kell blood group system is also sensitive to DTT treatment, supply K-negative units after ruling out or identifying alloantibodies using DTT-treated RBCs. If an emergency transfusion is required, administer non-cross-matched ABO/ RhD-compatible RBCs per local blood bank practices.

Interference with Serum Protein Electrophoresis and Immunofixation Tests

Daratumumab may be detected on serum protein electrophoresis (SPE) and immunofixation (IFE) assays used for monitoring disease monoclonal immunoglobulins (M protein). False positive SPE and IFE assay results may occur for patients with IgG kappa myeloma protein impacting the initial assessment of complete responses by International Myeloma Working Group (IMWG) criteria. In patients with persistent partial response, where daratumumab interference is suspected, consider using an FDA-approved daratumumab-specific IFE assay to distinguish daratumumab from any remaining endogenous M protein in the patient’s serum, to facilitate the determination of a complete response.

How does Darzalex work?

Daratumumab is an IgG1κ human monoclonal antibody (mAb) that binds to CD38 which is a transmembrane glycoprotein that expresses on the surface of hematopoietic cells, including multiple myeloma and other cell types and tissues. Daratumumab binds to CD38 and inhibits the growth of CD38-expressing tumor cells by inducing 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).

Darzalex Patient Stories⁶

Janssen Biotech through its SHARE network inspires others by sharing patient stories with all. Some of them are described below:

1. Story of Larry

Larry was diagnosed with the early stages of multiple myeloma in 2011. He is taking Darzalex in combination with Revlimid (lenalidomide) and dexamethasone. When his disease progressed, he was not eligible for a stem cell transplant. His doctor enrolled him in the MAIA clinical trial. Larry says, “When you hear the word cancer you get scared—quite frankly, angry, why me?”

2. Story of Deb

Deb was diagnosed with multiple myeloma in 2009. She is taking Darzalex as monotherapy. After being on multiple treatments, she is now responding to the treatment. She says “One of the things with cancer is that it never takes place at a good time…”

3. Story of Jim

Jim was diagnosed with multiple myeloma in 2015 at the age of 50. After his first relapse, he started the treatment with Darzalex. He is taking it in combination with Revlimid (lenalidomide) and dexamethasone. Jim says “So every treatment, every doctor’s appointment, and then every football game, I’ve worn this exact jersey…”

4. Story of Matt

Matt was diagnosed with multiple myeloma in 2011. His diagnosis was confusing and overwhelming. After receiving prior therapies and relapsing, Darzalex was added as a part of his regimen. He is taking Darzalex in combination with Pomalyst (pomalidomide) and dexamethasone. He says, “How I see myself and my purpose in the world has changed.”

Watch out the patient stories on https://www.darzalex.com/

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