**A Groundbreaking ADC Drug for Cervical Cancer Approved in China Macau**

**A Groundbreaking ADC Drug for Cervical Cancer Approved in China Macau**

Cervical Cancer

On August 6, 2024, Zai Lab proudly announced the approval of TIVDAK® (tisotumab vedotin-tftv) in Macau, marking the world’s first ADC (antibody-drug conjugate) specifically for cervical cancer. This innovative treatment is intended for patients with recurrent or metastatic cervical cancer who have experienced disease progression during or after chemotherapy.

TIVDAK stands as a significant milestone, being the first ADC drug approved by the FDA for cervical cancer. Following its accelerated approval in 2021, the FDA granted full approval in April 2024, solidifying its use for patients needing treatment after chemotherapy failure.

The FDA’s full approval was backed by positive outcomes from the global Phase 3 clinical trial, innovaTV 301. This study demonstrated that patients treated with TIVDAK experienced an overall survival benefit compared to those receiving chemotherapy. This finding is particularly noteworthy, as TIVDAK is the first ADC drug globally to show clear survival benefits for patients with second and third-line metastatic or recurrent cervical cancer.

Cervical cancer remains a leading threat in women’s health. Despite advancements in prevention through vaccination and early diagnosis via screening, there remains a significant unmet need for effective treatments. In China alone, an estimated 150,000 new cases are diagnosed each year, with approximately 60,000 fatalities. At the time of diagnosis, around 15% of adult patients have metastatic disease. For those diagnosed early and receiving treatment, up to 61% experience recurrence.

Zai Lab is participating in the global innovaTV 301 study and anticipates submitting a marketing application in China by early 2025. This approval in Macau represents a significant step forward in providing new hope for cervical cancer patients worldwide.

🎉🎉To assess whether the condition is suitable for CAR-T or clinic therapy, you can submit Advanced Medicine in China  for preliminary evaluation!

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Email: doctor.huang@globecancer.com

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