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Astellas recently announced that it has submitted a new drug application (NDA) for the targeted anticancer drug Padcev (enfortumab vedotin) to the Japanese Ministry of Health, Labour and Welfare (MHLW), which is used to treat the condition after receiving anticancer drug treatment.
Urothelial carcinoma (UC) is the most common type of bladder cancer, accounting for approximately 90% of bladder cancer cases.
In December 2019, Padcev received accelerated approval from the US FDA for the treatment of patients with locally advanced or metastatic urothelial cancer (UC, the most common type of bladder cancer), specifically: Has received a PD-1/L1 inhibition in the past Patients who have received a platinum-containing chemotherapy regimen before surgery (neoadjuvant) or after surgery (adjuvant) or in the treatment of locally advanced or metastatic disease.
It is worth mentioning that Padcev is the world's first ADC drug approved for the treatment of UC, and also the first approved for locally advanced or metastatic patients who have previously received platinum-containing chemotherapy and a PD-1 or PD-L1 inhibitor.
In Japan, Padcev's NDA is based on the results of two global clinical trials (EV-301, EV-201), which have clinical trial sites in Japan.
The Phase 2 EV-201 trial evaluated the efficacy and safety of Padcev in locally advanced or metastatic UC patients who have been treated with PD-1/PD-L1 inhibitors, including patients who have also received platinum-containing chemotherapy (cohort 1 ) And patients who have not received platinum-containing chemotherapy and are not eligible for cisplatin therapy (column 2).
In February of this year, Astellas and Seattle Genetics submitted two supplementary biological product licensing applications (sBLA) to the US FDA.
The FDA will review these two applications under the real-time oncology review (RTOR) pilot program.
Among them, seeking routine approval of Padcev's sBLA is based on data from the global phase 3 EV-301 confirmatory test.
Original source: Astellas Submits New Drug application for Enfortumab Vedotin in Japan
