VITRAKVI Maintains Market Leadership Across the 7MM Amid Growing TRK Inhibitor Competition | DelveInsight

VITRAKVI has strong market potential as a first-in-class TRK inhibitor for patients with NTRK gene fusion-positive cancers, regardless of tumor type. The growing adoption of precision oncology and increased genetic testing are key drivers for market growth. However, competition from other TRK inhibitors like entrectinib and pricing considerations may impact its commercial success.

LAS VEGAS, March 17, 2025 /PRNewswire/ -- DelveInsight's "VITRAKVI Market Size, Forecast, and Market Insight Report" highlights the details around VITRAKVI, a TRK, TRKA, TRKB, and TRKC inhibitor. The report provides product descriptions, patent details, and competitor products (marketed and emerging therapies) of VITRAKVI. The report also highlights the historical and forecasted sales from 2020 to 2034 segmented into 7MM [the United States, the EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan].

Bayer's VITRAKVI (larotrectinib) Overview

VITRAKVI is a targeted cancer therapy designed to treat solid tumors that harbor NTRK gene fusions. It functions as an inhibitor of TRK proteins (TRKA, TRKB, and TRKC). In enzyme assays, larotrectinib demonstrated potent inhibition of TRKA, TRKB, and TRKC, with IC50 values ranging from 5 to 11 nM, while another kinase, TNK2, required concentrations nearly 100 times higher for inhibition. The TRK proteins are encoded by the NTRK1, NTRK2, and NTRK3 genes, and chromosomal rearrangements leading to in-frame fusions of these genes with various partners can result in constitutively active TRK fusion proteins. These fusion proteins act as oncogenic drivers, promoting tumor cell growth and survival.

NTRK gene fusion is a rare genetic alteration found in tumors originating from various organs, including the lungs, thyroid, and intestines. VITRAKVI is indicated for patients with advanced or metastatic tumors that are not suitable for surgical removal and lack other viable treatment options.

Recommended VITRAKVI Dosage:

• Adults and pediatric patients with a body surface area (BSA) of ≥1.0 m²: 100 mg orally twice daily, with or without food, until disease progression or unacceptable toxicity occurs.
• Pediatric patients with a BSA <1.0 m²: 100 mg/m² orally twice daily, with or without food, until disease progression or unacceptable toxicity occurs.

Learn more about VITRAKVI projected market size for NSCLC @ VITRAKVI Market Potential 

NTRK inhibitors are a class of targeted therapies used in the treatment of NSCLC harboring neurotrophic tyrosine receptor kinase (NTRK) gene fusions. These rare oncogenic fusions drive tumor growth and are found in approximately 0.2%-3% of NSCLC cases. First-generation NTRK inhibitors like larotrectinib (Vitrakvi) and entrectinib (Rozlytrek) have shown durable responses and high efficacy in NTRK fusion-positive NSCLC, leading to their accelerated approvals by regulatory agencies. However, acquired resistance remains a challenge, prompting the development of next-generation inhibitors such as repotrectinib, which aims to overcome resistance mutations like G595R and G623R in TRK proteins.

The market dynamics for NTRK inhibitors in NSCLC are shaped by their rarity, high treatment costs, and competition within the precision oncology space. Due to the low prevalence of NTRK fusions, these drugs cater to a niche market, leading to high pricing models and reimbursement challenges. However, as comprehensive genomic profiling (CGP) becomes more widespread in NSCLC diagnostics, more patients are being identified for targeted treatment, potentially expanding the market. Additionally, competition from other targeted therapies, including RET and MET inhibitors, as well as emerging bispecific antibodies, could impact market penetration. Pharmaceutical companies are focusing on improving accessibility through expanded indications, combination strategies, and patient support programs to sustain market growth.

Discover more about the NTRK inhibitors market in detail @ NTRK Inhibitors Market Report

Emerging Competitors of VITRAKVI

Currently, there are only two NTRK inhibitors, namely, DOVBLERON (taletrectinib/AB-106/IBI-344) (Nuvation Bio/Innovent Biologics/Daiichi Sankyo/Nippon Kayaku) and ANS03 (Avistone Biotechnology), being evaluated for NSCLC. 

Taletrectinib (AB-106/IBI-344) is a next-generation, selective ROS1 inhibitor designed for treating advanced ROS1-positive NSCLC. It is an oral, potent, and CNS-active therapy currently being evaluated in two pivotal Phase II single-arm studies: TRUST-I (NCT04395677) in China and TRUST-II (NCT04919811), a global trial. Based on TRUST-I study results, China's NMPA has accepted the New Drug Application (NDA) for taletrectinib and granted it Priority Review Designation for adult patients with locally advanced or metastatic ROS1-positive NSCLC, regardless of prior ROS1 TKI treatment.  

In December 2024, Nuvation Bio announced that the US FDA had granted Priority Review to the application, setting a Prescription Drug User Fee Act (PDUFA) target date for June 2025. The company is preparing for a potential launch as early as mid-2025. Additionally, in November 2024, Nippon Kayaku stated its intention to launch taletrectinib in Japan within the 2025 fiscal year.

ANS03, a type II inhibitor, offers a broader range of resistance mutation inhibition by not only occupying the ATP-binding pocket of the kinase in its inactive "DFG-out" conformation but also extending into the adjacent allosteric pocket. This unique mechanism grants ANS03 a distinct pharmacodynamic advantage. Designed as a best-in-class oral small-molecule therapy, ANS03 aims to address the challenges of acquired drug resistance in patients with ROS1/NTRK fusion mutant cancers. It effectively inhibits ROS1/NTRK kinase activity across a broader spectrum, including wild-type ROS1/NTRK fusion and multiple drug-resistant mutations. 

In December 2024, Beijing Avistone Biotechnology Co., Ltd announced that the FDA had cleared the investigational new drug (IND) application for ANS03, a next-generation TKI targeting both ROS1 and NTRK. Patient enrollment for those with locally advanced or metastatic tumors harboring ROS1 or NTRK alterations is expected to commence in Q1 2025.

To know more about the number of competing drugs in development, visit @ VITRAKVI Market Positioning Compared to Other Drugs

Key Milestones of VITRAKVI 

• In March 2021, VITRAKVI was approved by PMDA to treat NTRK fusion gene-positive advanced or recurrent solid tumors.
• In September 2019, larotrectinib was approved in the EU under the brand name VITRAKVI for the treatment of adult and pediatric patients with solid tumors that display an NTRK gene fusion, who have a disease that is locally advanced, metastatic, or where surgical resection is likely to result in severe morbidity, and who have no satisfactory treatment options.
• In 2019, following the acquisition of Loxo Oncology by Eli Lilly and Company in February, Bayer obtained exclusive licensing rights for global development and commercialization, including in the US, for larotrectinib
• In May 2019, Bayer signed a collaboration agreement with Foundation Medicine, Cambridge, Massachusetts, United States, for developing and commercializing therapy accompanying diagnostic tests, also known as companion diagnostics (CDx), based on next-generation sequencing for new cancer drugs developed by Bayer.
• In November 2018, the US FDA granted accelerated approval to VITRAKVI for the treatment of adult and pediatric patients with solid tumors that have an NTRK gene fusion without a known acquired resistance mutation, are metastatic, or where surgical resection is likely to result in severe morbidity and have no satisfactory alternative treatments or that have progressed following treatment.
• In March 2018, Bayer and Loxo Oncology submitted an NDA for larotrectinib to the US FDA. In May 2018, the application was accepted and granted priority review status.
• In November 2017, Loxo Oncology and Bayer entered a global collaboration for developing and commercializing the TRK inhibitors VITRAKVI and LOXO-195.
• In May 2017, the US FDA granted ODD to VITRAKVI for treating solid tumors with NTRK-fusion proteins.
• In July 2016, the US FDA also granted VITRAKVI, BTD for the treatment of unresectable or metastatic solid tumors with NTRK-fusion proteins in adult and pediatric patients who require systemic therapy and who have either progressed following prior treatment or who have no acceptable alternative treatments.

Discover how VITRAKVI is shaping the NSCLC treatment landscape @ Bayer VITRAKVI 

VITRAKVI Market Dynamics

The market for VITRAKVI is driven by increasing adoption of genomic testing, growing awareness of NTRK fusion-driven cancers, and the drug's high response rate across multiple tumor types. However, its market expansion is limited by challenges such as the rarity of NTRK fusion-positive tumors and the high cost of treatment, which can impact reimbursement and patient accessibility.

Competition in the NTRK inhibitor space is a key factor shaping VITRAKVI's market dynamics. Its primary competitor is ROZLYTREK (entrectinib) from Roche, which also targets NTRK fusions but has additional activity against ROS1 and ALK mutations. The availability of multiple options in this niche market necessitates differentiation based on efficacy, safety profile, and tolerability. While VITRAKVI has demonstrated strong efficacy with a durable response rate, competitive pricing strategies and market penetration efforts will influence its long-term commercial success.

Regulatory and reimbursement policies also play a crucial role in VITRAKVI's market adoption. In regions with favorable precision oncology reimbursement frameworks, such as the U.S. and parts of Europe, adoption is relatively higher. However, in emerging markets where genetic testing infrastructure is still developing, uptake remains slow. Partnerships with diagnostic companies to increase NTRK testing and initiatives to improve affordability through patient assistance programs could enhance accessibility.

Looking ahead, Bayer's strategy for expanding VITRAKVI's market presence may involve label expansions, combination therapy trials, and efforts to integrate it into treatment guidelines for various cancers. As more oncologists and healthcare providers become familiar with tumor-agnostic therapies, demand for targeted treatments like VITRAKVI is expected to grow. However, overcoming diagnostic barriers, ensuring competitive pricing, and managing payer negotiations will be key to sustaining its market growth.

Dive deeper to get more insight into VITRAKVI's strengths & weaknesses relative to competitors @ VITRAKVI Market Drug Report

Table of Contents

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