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Last Updated: February 12, 2025

Tisotumab vedotin-tftv - Biologic Drug Details


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Summary for tisotumab vedotin-tftv
Tradenames:1
High Confidence Patents:0
Applicants:1
BLAs:1
Suppliers: see list1
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
  2. 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.

  3. General brand-side disclosures
  4. 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.

  5. Patents from broad patent text search
  6. 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 tisotumab vedotin-tftv Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for tisotumab vedotin-tftv Derived from Company Disclosures

No patents found based on company disclosures

3) Low Certainty: US Patents for tisotumab vedotin-tftv Derived from Patent Text Search

No patents found based on company disclosures

Market Dynamics and Financial Trajectory for Tisotumab Vedotin-tftv

Introduction to Tisotumab Vedotin-tftv

Tisotumab vedotin-tftv, commonly known as Tivdak, is an antibody-drug conjugate (ADC) developed by Genmab and Seagen, targeting tissue factor (TF) in various solid tumors, including cervical cancer[1]. This novel therapeutic agent has shown significant advancements in treating recurrent or metastatic cervical cancer.

Mechanism of Action

Tisotumab vedotin-tftv works by binding to TF on the surface of cancer cells, internalizing the ADC, and releasing a highly potent cytotoxic payload within the cell. This targeted delivery mechanism enhances efficacy while minimizing systemic side effects[1].

Clinical Trials and Efficacy

The drug has demonstrated promising results in clinical trials, particularly in the global randomized open-label phase III innovaTV 301/ENGOT-cx12/GOG-3057 trial. In this trial, treatment with tisotumab vedotin-tftv resulted in a statistically significant 30% reduction in the risk of death in patients previously treated for recurrent or metastatic cervical cancer compared to investigator’s choice of single-agent chemotherapy[2].

Key Efficacy Outcomes:

  • Overall Survival (OS): Median OS was 11.5 months with tisotumab vedotin-tftv and 9.5 months with chemotherapy (Hazard Ratio [HR] = 0.70; p-value = 0.0038)[2].
  • Progression-Free Survival (PFS): Median PFS was 4.2 months with tisotumab vedotin-tftv and 2.9 months with chemotherapy (HR = 0.67; p-value <0.0001)[2].
  • Confirmed Objective Response Rate (ORR): Confirmed ORR was 17.8% with tisotumab vedotin-tftv and 5.2% with chemotherapy (p-value <0.0001)[2].

Regulatory Approvals

Tisotumab vedotin-tftv received accelerated approval from the U.S. Food and Drug Administration (FDA) for the treatment of recurrent or metastatic cervical cancer that has progressed on or after chemotherapy[1]. On April 29, 2024, the FDA granted traditional approval to tisotumab vedotin-tftv for this indication[5].

Market Competition

The global ADC market is highly competitive, with several ADCs targeting various cancers at different stages of development. Key competitors include Roche's Kadcyla (T-DM1) for HER2-positive breast cancer and Seattle Genetics' Adcetris (Brentuximab vedotin) for Hodgkin lymphoma and systemic anaplastic large cell lymphoma[1].

Financial Trajectory

The financial trajectory for tisotumab vedotin-tftv is influenced by its potential to address a critical unmet medical need in cervical cancer treatment. The Priority Review designation by the FDA indicates recognition of the drug's potential significance, which could lead to a faster-than-normal review process and quicker market entry[3].

Market Impact:

  • Investor Perception: The FDA’s acceptance of the supplemental Biologics License Application (sBLA) for tisotumab vedotin-tftv is a positive development for investors and stakeholders in Pfizer and Genmab, potentially influencing stock market perception positively[3].
  • Market Penetration: Long-term success will depend on market penetration, pricing strategies, insurance coverage, and maintaining a favorable safety profile in broader patient populations[3].

Future Research Directions

Future research will focus on expanding the use of tisotumab vedotin-tftv to other TF-expressing cancers and exploring combination therapies to further enhance its therapeutic benefits[1]. Ongoing clinical trials will continue to evaluate its safety and efficacy, positioning it as a promising therapeutic option for cervical cancer treatment.

Key Takeaways

  1. Targeted Therapy: Tisotumab vedotin-tftv represents a significant advancement in targeted cancer therapy, specifically targeting TF-expressing tumors.
  2. Clinical Efficacy: The drug has demonstrated substantial clinical efficacy in improving overall survival and progression-free survival in patients with recurrent or metastatic cervical cancer.
  3. Regulatory Approvals: Traditional FDA approval for tisotumab vedotin-tftv underscores its potential as a standard treatment option for cervical cancer.
  4. Market Competition: Despite intense competition in the ADC market, tisotumab vedotin-tftv stands out due to its specific targeting mechanism and promising results in clinical trials.
  5. Financial Implications: The drug’s financial trajectory is influenced by its potential to address a critical unmet medical need and the positive regulatory developments.

FAQs

  1. What is the mechanism of action of tisotumab vedotin-tftv?

    • Tisotumab vedotin-tftv works by binding to TF on the surface of cancer cells, internalizing the ADC, and releasing a cytotoxic payload within the cell[1].
  2. What are the key efficacy outcomes of tisotumab vedotin-tftv in clinical trials?

    • The drug has shown a statistically significant 30% reduction in the risk of death, with median OS of 11.5 months and median PFS of 4.2 months[2].
  3. What are the most common adverse reactions associated with tisotumab vedotin-tftv?

    • Common adverse reactions include decreased hemoglobin, peripheral neuropathy, conjunctival adverse reactions, increased aspartate aminotransferase, nausea, increased alanine aminotransferase, fatigue, decreased sodium, epistaxis, and constipation[5].
  4. Has tisotumab vedotin-tftv received regulatory approvals?

    • Yes, it received accelerated approval from the FDA and traditional approval for the treatment of recurrent or metastatic cervical cancer[1][5].
  5. What are the future research directions for tisotumab vedotin-tftv?

    • Future research will focus on expanding its use to other TF-expressing cancers and exploring combination therapies to enhance its therapeutic benefits[1].

Cited Information:

  1. [1] Synapse Patsnap Blog: "How to find the core components of Tisotumab Vedotin-tftv?"
  2. [2] ASCO Post: "In Recurrent Cervical Cancer, Tisotumab Vedotin-tftv Improves Overall Survival in Phase III Trial"
  3. [3] Stock Titan Net: "TIVDAK® Supplemental Biologics License Application Accepted for Review"
  4. [4] PubMed: "A Review of Tisotumab Vedotin-tftv in Recurrent or Metastatic Cervical Cancer"
  5. [5] FDA: "FDA Approves Tisotumab Vedotin-tftv for Recurrent or Metastatic Cervical Cancer"

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