An innovative medicine, called TIVDAK (tisotumab vedotin), has shown extremely promising results in phase 3 clinical trials. This news is a significant advance in the care of this devastating disease, which affects many women around the world.
In global Phase 3 clinical trials, TIVDAK has shown an overall 30% reduction in the risk of death compared to chemotherapy, an achievement that has been enthusiastically received by the medical community. Additionally, the drug has also shown a 33% decrease in the risk of disease worsening or death, further reinforcing its effectiveness.
One of the most notable aspects of TIVDAK is its improved objective response rate of 17.8%, compared to chemotherapy, which only reaches 5.2%. This difference is a clear indication of the effectiveness of this new drug in the fight against cervical cancer. Additionally, the drug has demonstrated a disease control rate of 75.9%, compared to 58.2% for chemotherapy.
In an interview with Dr. Brian Slomovitz, director of gynecologic oncology at Mount Sinai Medical Center in Miami Beach, Florida, the importance of these findings was emphasized. Dr. Slomovitz, who has been directly involved in the trials, noted that “having an overall survival advantage in this disease is extremely, extremely rare.”
Furthermore, he added that This advance “changes the standard of second-line care for this disease” and that “all patients who recur after therapy first-line should be considered for this therapy.”
TIVDAK represents a new class of drugs that target a specific protein in the cell, allowing chemotherapy to precisely reach the affected cell, thus avoiding many of the peripheral side effects associated with traditional chemotherapy. This means that patients can benefit from more effective treatment with fewer consequences.
Mild side effects
Despite some side effects, such as conjunctivitis, peripheral neuropathy and eye bleeding, Dr. Kathleen Moore, associate director of clinical research at Stephenson Cancer Center in Oklahoma City, believes they are manageable.
According to her, most patients can control and mitigate these side effects by using prescription eye drops. and cold compresses before starting treatment.
The data supports this claim, as only 5% of patients have had to stop treatment due to side effects. In comparison, chemotherapy carries a “much higher risk” of side effects, such as anemia, nausea, hair loss and neutropenia, according to Dr. Slomovitz.
Doctors who have been using TIVDAK since its accelerated FDA approval in 2021 report that patients have responded positively to the treatment and appreciate its effectiveness and accessibility through insurance. This represents a significant change in the care of this disease, which previously lacked truly effective treatments.
Cervical cancer is one of the main causes of mortality among women, and this advance in therapy is encouraging news for all patients fighting this disease. Doctors express optimism that the FDA will grant full approval to TIVDAK in the near future, which would have a significant impact on patient care.
Both Dr. Slomovitz and Dr. Moore share the hope that this drug will be approved globally, which could mark a milestone in the fight against advanced metastatic cervical cancer.
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