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Padev: The first innovative drug for bladder cancer!
Padev: The first innovative drug for bladder cancer! The first innovative drug for bladder cancer! New ADC drug Padcev applied for marketing in Japan: treatment of patients refractory to PD-(L)1 inhibitors!
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. Patients with advanced locally advanced or metastatic urothelial carcinoma (UC, the most common type of bladder cancer). If approved, Padcev will become Japan’s first antibody-conjugated drug (ADC) against this type of urothelial cancer (UC).
Urothelial carcinoma (UC) is the most common type of bladder cancer, accounting for approximately 90% of bladder cancer cases. Padcev is a first-in-class ADC drug that targets a cell surface protein that is highly expressed in bladder cancer. The drug is a combination of enfortumab, a human IgG1 monoclonal antibody targeting connexin-4 (Nectin-4), and the cytotoxic agent MMAE (monomethyl auristatin E, a microtubule disrupting agent). . Nectin-4 is a therapeutic target highly expressed in a variety of solid tumors including urothelial carcinoma (UC). In the drug, the ADC link technology comes from Seattle Genetics (Seagen), and the target identification is completed by Astellas.
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-based chemotherapy regimen before or after 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. Medications for UC patients. In the United States, the drug was approved through the FDA’s priority review process. Previously, the FDA has granted Padcev the breakthrough drug qualification for the treatment of the aforementioned UC patients.
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 3 EV-301 confirmatory trial was conducted in adult patients with locally advanced or metastatic urothelial carcinoma who had previously received platinum-based chemotherapy and a PD-1/L1 inhibitor, comparing Padcev with chemotherapy.
The results showed that the median follow-up was 11.1 months. Compared with the chemotherapy group, the overall survival of the Padcev group was significantly longer (median OS: 12.88 months vs. 8.97 months; HR=0.70; p=0.001) and progression-free survival Significantly prolonged (median PFS: 5.55 months vs 3.71 months; HR=0.62; p<0.001).
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).
The results from cohort 1 showed that Padcev treatment rapidly reduced tumors in most patients, with an objective response rate (ORR) of 44% (55/125, 95% CI: 35.1-53.2) and a complete response rate (CR) of 12% (15/125), the median duration of response (DOR) was 7.6 months (range: 0.95-11.3+).
The results from cohort 2 showed that among the patients treated with Paddev, the confirmed objective response rate (ORR) was 52%, of which the complete response rate (CR) was 20%; the median duration of response (mDOR) was 10.9 months, and the Progression-free survival (mPFS) and median overall survival (mOS) were 5.8 months and 14.7 months, respectively.
In February of this year, Astellas and Seattle Genetics submitted two supplementary biological product licensing applications (sBLA) to the US FDA. One is based on the Phase 3 EV-301 trial, which aims to transform Padcev from accelerated approval to routine approval. The second cohort based on the pivotal EV-201 trial aims to expand the current drug label to include locally advanced or metastatic patients who have been treated with a PD-1/L1 inhibitor and are not eligible for cisplatin therapy Patients with urothelial carcinoma (UC).
The FDA will review these two applications under the real-time oncology review (RTOR) pilot program. The RTOR project aims to explore a more effective review process to ensure that safe and effective treatments are provided to patients as early as possible.
Among them, seeking routine approval of Padcev’s sBLA is based on data from the global phase 3 EV-301 confirmatory test. The second sBLA is based on the results of the second cohort of the critical phase 2 EV-201 trial. The EV-301 trial reached the primary endpoint of improving overall survival (OS) and confirmed the objective response data in the EV-201 trial.
(source:internet, reference only)