Amivantamab-vmjw - Biologic Drug Details

Summary for amivantamab-vmjw

Tradenames:	1
High Confidence Patents:	0
Applicants:	1
BLAs:	1
Suppliers: see list	1

Note on Biologic Patents

Matching patents to biologic drugs is far more complicated than for small-molecule drugs.

DrugPatentWatch employs three methods to identify biologic patents:

1. Brand-side disclosures in response to biosimilar applications

These patents were identified from disclosures by the brand-side company, in response to a potential biosimilar seeking to launch. They have a high certainty of blocking biosimilar entry. The expiration dates listed are not estimates — they're expiration dates as indicated by the brand-side company.

2. General brand-side disclosures

These patents were identified from searching drug labels and other general disclosures from the brand-side company. This list may exclude some of the patents which block biosimilar launch, and some of these patents listed may not actually block biosimilar launch. The expiration dates listed for these patents are estimates, based on the grant date of the patent.

3. Patents from broad patent text search

For completeness, these patents were identified by searching the patent literature for mentions of the branded or ingredient name of the drug. Some of these patents protect the original drug, whereas others may protect follow-on inventions or even inventions casually mentioning the drug. The expiration dates listed for these patents are estimates, based on the grant date of the patent.

1) High Certainty: US Patents for amivantamab-vmjw Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for amivantamab-vmjw Derived from Company Disclosures

These patents were obtained from company disclosures

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Patent No.	Estimated Patent Expiration	Source
Janssen Biotech, Inc.	RYBREVANT	amivantamab-vmjw	Injection	761210		2039-02-26	Company disclosures
Janssen Biotech, Inc.	RYBREVANT	amivantamab-vmjw	Injection	761210		2033-11-21	Company disclosures
Janssen Biotech, Inc.	RYBREVANT	amivantamab-vmjw	Injection	761210		2036-12-21	Company disclosures

3) Low Certainty: US Patents for amivantamab-vmjw Derived from Patent Text Search

These patents were obtained by searching patent claims

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Patent No.	Estimated Patent Expiration	Source

Market Dynamics and Financial Trajectory for the Biologic Drug: Amivantamab-vmjw

Introduction

Amivantamab-vmjw, marketed as Rybrevant, is a groundbreaking bispecific antibody that has revolutionized the treatment landscape for non-small cell lung cancer (NSCLC) patients, particularly those with specific epidermal growth factor receptor (EGFR) mutations. This article delves into the market dynamics and financial trajectory of this biologic drug, highlighting its approval, efficacy, safety, and market impact.

Approval and Regulatory Framework

On May 21, 2021, the FDA granted accelerated approval to amivantamab-vmjw for adult patients with locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations, following the results of the CHRYSALIS clinical trial[1]. This approval was facilitated under the FDA's Project Orbis initiative, which enables concurrent submission and review of oncology drugs among international regulatory agencies[1].

Efficacy and Clinical Outcomes

The efficacy of amivantamab-vmjw has been demonstrated through several clinical trials. In the CHRYSALIS trial, the overall response rate (ORR) was 40% with a median response duration of 11.1 months[1]. For patients with EGFR exon 19 deletions or exon 21 L858R substitution mutations, the MARIPOSA-2 trial showed a median progression-free survival (PFS) of 6.3 months when combined with carboplatin and pemetrexed, significantly outperforming the chemotherapy-only arm[4].

Safety Profile

The safety profile of amivantamab-vmjw includes common adverse reactions such as rash, infusion-related reactions, paronychia, musculoskeletal pain, and others. These side effects are manageable and reflect the drug's targeted mechanism of action[1][4].

Market Impact

Targeted Therapy

Amivantamab-vmjw represents a significant advancement in targeted therapy for NSCLC, particularly for patients with EGFR mutations who have limited treatment options after progressing on platinum-based chemotherapy or EGFR tyrosine kinase inhibitors[2].

Competitive Landscape

The biologics market, which includes drugs like amivantamab-vmjw, has grown substantially, now representing 42% of the total medicines market, up from 30% in 2014. This growth is driven by the increasing demand for targeted and effective treatments for complex diseases like cancer[3].

Financial Trajectory

The approval and subsequent use of amivantamab-vmjw are expected to contribute significantly to the financial performance of its manufacturer, Janssen Biotech, Inc. The drug's unique mechanism and strong clinical outcomes position it for substantial market share in the NSCLC treatment space.

Revenue Potential

Given its breakthrough therapy designation and the unmet clinical needs it addresses, amivantamab-vmjw has considerable revenue potential. The drug's ability to delay time to next therapy by 10 months compared to available therapies further underscores its economic value[2].

Market Exclusivity and Biosimilar Competition

While biologics like amivantamab-vmjw enjoy market exclusivity, the landscape is shifting with the emergence of biosimilars. However, the complexity of biosimilar development and the stringent regulatory requirements mean that amivantamab-vmjw will likely maintain its market position for several years before facing significant biosimilar competition[3].

Subcutaneous Formulation

The recent Priority Review granted by the FDA for the subcutaneous formulation of amivantamab-vmjw is expected to further enhance its market appeal and patient compliance. This formulation, backed by strong interim overall survival data, is anticipated to expand treatment options and reinforce the drug's financial trajectory[5].

Global Collaboration and Regulatory Approvals

The approval process for amivantamab-vmjw has been facilitated through international collaboration under Project Orbis, involving regulatory agencies such as ANVISA, MHRA, TGA, and Health Canada. This collaborative approach ensures a streamlined and efficient regulatory pathway, contributing to the drug's global market penetration and financial success[1][4].

Key Takeaways

• Accelerated Approval: Amivantamab-vmjw received accelerated approval for NSCLC patients with EGFR exon 20 insertion mutations.
• Efficacy: Demonstrated a 40% ORR and a median response duration of 11.1 months in the CHRYSALIS trial.
• Safety: Common adverse reactions include rash, infusion-related reactions, and musculoskeletal pain.
• Market Impact: Represents a significant advancement in targeted therapy for NSCLC, with substantial revenue potential.
• Competitive Landscape: Part of a growing biologics market, with limited immediate biosimilar competition.
• Subcutaneous Formulation: Pending regulatory approval, expected to enhance patient compliance and market appeal.

FAQs

What is amivantamab-vmjw and how does it work?

Amivantamab-vmjw is a bispecific antibody that targets both EGFR and MET receptors, addressing resistance mechanisms in NSCLC patients with specific EGFR mutations.

What are the approved indications for amivantamab-vmjw?

It is approved for adult patients with locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations and those with EGFR exon 19 deletions or exon 21 L858R substitution mutations who have progressed on or after certain treatments.

What are the common adverse reactions associated with amivantamab-vmjw?

Common adverse reactions include rash, infusion-related reactions, paronychia, musculoskeletal pain, and others.

How does amivantamab-vmjw compare to other treatments in terms of efficacy?

It has demonstrated a significant improvement in overall response rate and progression-free survival compared to chemotherapy alone in clinical trials.

What is the current status of the subcutaneous formulation of amivantamab-vmjw?

The subcutaneous formulation has received Priority Review from the FDA and is pending regulatory approval, with interim data showing a strong favorable trend in overall survival.

Sources

1. FDA Grants Accelerated Approval to Amivantamab-vmjw for Metastatic Non-Small Cell Lung Cancer. FDA.
2. Amivantamab Paves a New Treatment Path for Patients With EGFR Exon 20 Mutant NSCLC. OncLive.
3. Biologics Market Dynamics: Setting the Stage for Biosimilars. FTC.
4. FDA Approves Amivantamab-vmjw with Carboplatin and Pemetrexed for Non-Small Cell Lung Cancer. FDA.
5. Update on U.S. Regulatory Review of Subcutaneous Amivantamab. Johnson & Johnson.

Last updated: 2024-12-22