TOKYO—Astellas Pharma Inc. (TYO: 4503) has announced that its anti-HER3 antibody-drug conjugate (ADC), Padcev (enfortumab vedotin), in partnership with Pfizer, has been granted approval by China’s National Medical Products Administration (NMPA) for the treatment of adult patients with locally advanced or metastatic urothelial cancer (la/mUC) who have received prior platinum-containing chemotherapy and PD-1 or PD-L1 inhibitors. This marks a significant expansion of Padcev’s reach in the critical Chinese market.
Padcev, which targets Nectin-4, a protein highly expressed in bladder cancer cells, was fast-tracked by the US FDA in December 2019 and received full approval in 2021. The drug is now awaiting regulatory decisions in China, where it is being studied in combination with pembrolizumab for first-line treatment of la/mUC.
The approval in China follows a global trend of recognizing the potential of Padcev in treating urothelial cancer. The drug has demonstrated the ability to significantly reduce the annual acute attack rate (AAER) of asthma in SEA patients by 74% in clinical trials, meeting all primary and key secondary endpoints, and improving lung function and asthma symptoms.
Pfizer’s rights to Padcev stem from its acquisition of Astellas’ co-development partner, Seagen Inc. This strategic partnership highlights the importance of collaboration in advancing cutting-edge cancer treatments and underscores the commitment of both companies to improving patient outcomes globally.- Flcube.com
