What's Happening?
The FDA has not yet approved CXU™, a flowable gel for complex wounds, as it requires further testing before the 510(k) submission. Meanwhile, Zai Lab has received approval from China's National Medical Products Administration (NMPA) for TIVDAK® (tisotumab
vedotin for injection) to treat adult patients with recurrent or metastatic cervical cancer. TIVDAK® had previously secured full approval from the U.S. FDA in April 2024 and was initially approved in September 2021 under the accelerated approval pathway. The drug is also approved in Japan, the European Union, Macau, and Hong Kong for the same indication. Zai Lab holds an exclusive license from Seagen Inc., acquired by Pfizer, for TIVDAK® in Greater China, where it is responsible for the drug's development, supply, and commercialization.
Why It's Important?
The approval of TIVDAK® in China marks a significant step in expanding treatment options for cervical cancer, a leading cause of cancer death among women in China. The drug's approval is based on the global Phase 3 innovaTV 301 clinical trial, which demonstrated a statistically significant overall survival benefit. This development underscores the importance of international collaboration in drug development and the potential for U.S.-developed treatments to impact global health. The FDA's pending decision on CXU™ highlights the rigorous process required for medical device approval in the U.S., emphasizing the need for thorough testing to ensure safety and efficacy.
What's Next?
Zai Lab plans to leverage its experience in the Chinese gynecologic oncology community to bring TIVDAK® to patients in China. The company will work on commercial synergies with its existing team to ensure the drug's availability. For CXU™, further testing is required before the FDA can consider its approval, which will determine its future availability in the U.S. market. The outcomes of these developments will be closely watched by stakeholders in the pharmaceutical and medical device industries, as they could influence future regulatory and commercial strategies.
