Breakthrough Cervical Cancer Treatment Wins Accelerated FDA Approval

Patients with recurrent or metastatic cervical cancer whose disease has progressed on or after chemotherapy may see a ray of hope soon after the U.S. Food and Drug Administration granted accelerated approval to Genmab and Seagen’s TIVDAK drug. 

TIVDAK (tisotumab vedotin-tftv) is the first and only approved antibody-drug conjugate (ADC) for the treatment of the said disease in adults. It earned the FDA’s green light after its Phase II innovaTV 204 clinical trial delivered stellar results in terms of tumor response and durability of the response. Continued approvals are likely, but not until further confirmatory trials verify more clinical benefits. 

In the Phase II trial, TIVDAK was observed in 101 patients who had recurrent or metastatic cervical cancer and has received a maximum of two prior systemic regimens, including one prior platinum-based chemotherapy treatment. 

After an assessment by an independent review committee (IRC) using the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, TIVDAK was revealed to have an objective response rate (ORR) of 95 percent, while the median duration of response (DOR) was 8.3 months. 

Approximately 14,480 new cases of invasive cervical cancer are expected to be diagnosed this year in the U.S. alone, and 4,290 women are likely to die from the disease. It is one of the leading causes of cancer death in the world. 

To Read the Complete Article at Pharmacy Times Click Here

Disclaimer: BioPharma Global is not responsible for, and expressly disclaims all liability for, damages of any kind arising out of use, reference to, or reliance on any information contained within the article. Content available through the site may contain links and information to other websites. Links from BioPharma Global to third-party sites do not constitute an endorsement by BioPharma Global of the mentioned parties.

BioPharma Global is a mission-driven corporation, operating like a not-for-profit, dedicated to using our FDA and EMA regulatory expertise and knowledge of various therapeutic areas to help drug developers advance treatments for the disease communities with a high unmet medical need. If you are a drug developer seeking regulatory support for Orphan Drug designation, Fast Track designation, Breakthrough Therapy designation, other FDA/EMA expedited programs, type A, B (pre-IND, EOPs), or C meeting assistance, or IND filings, the BioPharma Global team can help. Contact us today to arrange a 30-minute introductory call.

Stock image by peshkova from Depositphotos