Japan-based Astellas Pharma Inc. (TYO: 4503) and US biotech Seagen Inc. (Nasdaq: SGEN) have announced the completion of a market approval filing with the National Medical Products Administration (NMPA) in China for the antibody drug conjugate (ADC) enfortumab vedotin, marketed as Padcev in the US. The filing seeks approval for the drug’s use in treating locally advanced or metastatic urothelial carcinoma (UC) in patients who have previously been treated with a programmed death-1/ligand-1 (PD-(L)1) inhibitor plus chemotherapy.
Drug Profile and Previous Approvals
Enfortumab vedotin targets nectin-4, a protein highly expressed by bladder cancer cells. The drug received conditional US FDA approval for the same indication in 2019, which was expanded to full approval in 2021. It is currently used to treat UC in either second- or third-line settings in multiple global markets.
Clinical Data and Study Results
The China filing is supported by data from the EV-203 study (NCT04995419), a Phase II bridging study for Chinese patients. This study showed the drug performed as expected based on the results of the global Phase III EV-301 study. The EV-301 study demonstrated that Padcev treatment significantly improved overall survival compared to chemotherapy, at 12.9 months versus 9 months, indicating a 30% reduction in the risk of death.
Partnership and Development
Astellas and Seagen are co-developing Padcev globally as part of a partnership established in 2007. The collaboration involves Astellas supplying antibodies for combination using Seagen’s technology to create ADCs. While several molecules have emerged from this partnership, Padcev is the first to successfully reach the market, with both companies co-developing and globally co-commercializing the product with a 50:50 share of profits.
Significance of the Filing
The NMPA filing marks a significant step in expanding the availability of Padcev to patients in China, potentially offering a more effective treatment option for those with advanced urothelial carcinoma. This development underscores the ongoing commitment of Astellas and Seagen to advancing innovative cancer therapies globally.-Fineline Info & Tech
