Tisotumab forvedotin-tftv is approved for recurrent or metastatic cervical cancer

Share This Post

October 2021: The FDA has given tisotumab vedotin-tftv (Tivdak, Seagen Inc.), a tissue factor-directed antibody and microtubule inhibitor combination, rapid approval for adult patients with recurrent or metastatic cervical cancer who are progressing on or after chemotherapy.

InnovaTV 204, an open-label, multicenter, single-arm clinical trial, was used to gain approval (NCT03438396). In 101 patients with recurrent or metastatic cervical cancer who had had no more than two prior systemic regimens in the recurrent or metastatic context, including at least one prior platinum-based chemotherapy treatment, efficacy was assessed. Sixty-nine percent of patients had previously received bevacizumab as part of a systemic treatment regimen. Tisotumab vedotin-tftv 2 mg/kg was given to patients every 3 weeks until disease progression or unacceptable toxicity.

The primary efficacy outcome measures were the confirmed objective response rate (ORR), as determined by an independent review committee (IRC) using RECIST v1.1, and response duration (DOR). With a median response time of 8.3 months, the ORR was 24 percent (95 percent CI: 15.9%, 33.3 percent) (95 percent CI: 4.2, not reached).

Hemoglobin decreased, fatigue, lymphocytes decreased, nausea, peripheral neuropathy, alopecia, epistaxis, conjunctival adverse reactions, haemorrhage, leukocytes decreased, creatinine increased, dry eye, prothrombin international normalised ratio increased, activated partial thromboplastin time prolonged, diarrhoea, and rash were the most common adverse reactions (25 percent), including laboratory abnormalities. A boxed warning for ocular toxicity is included on the product label.

The recommended dose is 2 mg/kg (up to 200 mg for patients under 100 kg) administered as a 30-minute intravenous infusion every three weeks until disease progression or intolerable toxicity.

Take second opinion on cervical cancer treatment


Send Details

Subscribe To Our Newsletter

Get updates and never miss a blog from Cancerfax

More To Explore

Lutetium Lu 177 dotatate is approved by USFDA for pediatric patients 12 years and older with GEP-NETS
Cancer

Lutetium Lu 177 dotatate is approved by USFDA for pediatric patients 12 years and older with GEP-NETS

Lutetium Lu 177 dotatate, a groundbreaking treatment, has recently received approval from the US Food and Drug Administration (FDA) for pediatric patients, marking a significant milestone in pediatric oncology. This approval represents a beacon of hope for children battling neuroendocrine tumors (NETs), a rare but challenging form of cancer that often proves resistant to conventional therapies.

Nogapendekin alfa inbakicept-pmln is approved by the USFDA for BCG-unresponsive non-muscle invasive bladder cancer
Bladder cancer

Nogapendekin alfa inbakicept-pmln is approved by the USFDA for BCG-unresponsive non-muscle invasive bladder cancer

“Nogapendekin Alfa Inbakicept-PMLN, a novel immunotherapy, shows promise in treating bladder cancer when combined with BCG therapy. This innovative approach targets specific cancer markers while leveraging the immune system’s response, enhancing the efficacy of traditional treatments like BCG. Clinical trials reveal encouraging results, indicating improved patient outcomes and potential advancements in bladder cancer management. The synergy between Nogapendekin Alfa Inbakicept-PMLN and BCG heralds a new era in bladder cancer treatment.”

Need help? Our team is ready to assist you.

We wish a speedy recovery of your dear and near one.

Start chat
We Are Online! Chat With Us!
Scan the code
Hello,

Welcome to CancerFax !

CancerFax is a pioneering platform dedicated to connecting individuals facing advanced-stage cancer with groundbreaking cell therapies like CAR T-Cell therapy, TIL therapy, and clinical trials worldwide.

Let us know what we can do for you.

1) Cancer treatment abroad?
2) CAR T-Cell therapy
3) Cancer vaccine
4) Online video consultation
5) Proton therapy