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Home Astellas and Seagen Receive Positive CHMP Opinion for PADCEV™ (enfortumab vedotin) in Locally Advanced or Metastatic Urothelial Cancer

Astellas and Seagen Receive Positive CHMP Opinion for PADCEV™ (enfortumab vedotin) in Locally Advanced or Metastatic Urothelial Cancer

Dec 20, 2021 01:15 CST Updated 01:15
Astellas

Pharmaceutical R&D Manufacturer

Seagen

Monoclonal Antibody Developer

Committee for Medicinal Products for Human Use

Committee for Medicinal Products for Human Use (CHMP)The Committee for Medicinal Products for Human Use (CHMP) is the committee within the European Medicines Agency (EMA) responsible for human medicines. The CHMP replaced the former Committee for Proprietary Medicinal Products (CPMP) in May 2004.The CHMP plays a vital role in the authorization of medicines in the European Union (EU). In the centralized procedure, the CHMP is responsible for: 1) conducting initial assessments of marketing authorization applications across the EU; assessing modifications or extensions to existing marketing authorizations (“variations”); considering recommendations from the Agency’s Pharmacovigilance Risk Assessment Committee regarding the safety of medicines on the market, and, where necessary, advising the European Commission to amend the marketing authorization of a medicinal product, or to suspend or withdraw it from the market.The CHMP also evaluates medicines authorized at the national level that are referred to the EMA, with the aim of maintaining a harmonized position throughout the EU.Furthermore, the CHMP and its working groups promote the development of medicines and pharmaceutical regulation by: providing scientific advice to companies researching and developing new medicines; developing scientific and regulatory guidelines to assist pharmaceutical companies in preparing marketing authorization applications for human medicines; and collaborating with international partners to harmonize regulatory requirements.


Bladder Cancer - (Image Source - medscape.com)

December 18, 2021 /BioValleyBIOON/ -- Astellas and SeagenGeneticsSeagen recently announced jointly that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion, recommending the approval of the antibody-drug conjugate (ADC) Padcev (enfortumab vedotin): as a monotherapy for the treatment of adult patients with locally advanced or metastatic urothelial cancer (UC) who have previously received platinum-containing chemotherapy and PD-1/PD-L1 inhibitors.

If approved,Padcev to Become the First ADC Approved in the EU for Advanced UCUC is the most common type of bladder cancer, accounting for approximately 90% of bladder cancer cases. In Europe, it was estimated that 204,000 people were affected in 2020.DiagnosisFor patients with UC, more than 67,000 people die from the disease. Patients with advanced UC have few treatment options after platinum-based chemotherapy and immunotherapy.

Padcev is a first-in-class ADC drug that targets Nectin-4 (a cell surface protein highly expressed in bladder cancer).. This drug is composed of enfortumab, a human IgG1 monoclonal antibody targeting Nectin-4, conjugated with the cytotoxic agent MMAE (monomethyl auristatin E, a microtubule disruptor). Nectin-4 is a protein expressed in various solid tumors, including urothelial cancer (UC).TumorModerately to highly expressed therapeutic targets. In this drug, the ADC linker technology comes from Seagen.GeneticsSeagen, Inc., target identification completed by Astellas Pharma, Inc.

In December 2019, Padcev was granted accelerated approval by the U.S. FDA for the treatment of adult patients with locally advanced or metastatic UC, specifically: patients who have previously received a PD-1/L1 inhibitor and have also received a platinum-based chemotherapy regimen either before surgery (neoadjuvant) or after surgery (adjuvant), or in the treatment of locally advanced or metastatic disease. In July 2021, Padcev received regular approval from the FDA and obtainedFDAApproval for expanded indications: For the treatment of adult patients with locally advanced or metastatic UC who are ineligible for cisplatin chemotherapy and have previously received first-line or multiple lines of therapy.

It is worth mentioning that,Padcev is the world's first ADC drug approved for the treatment of UC, and it is also the first drug approved for patients with locally advanced or metastatic UC who have previously received platinum-containing chemotherapy and a PD-1 or PD-L1 inhibitor.Previously,FDAPadcev has been granted Breakthrough Therapy designation for the treatment of the aforementioned UC patients.

In the EU, the positive review opinion of the CHMP is based on data from the global Phase 3 EV-301 confirmatory trial. This trial was conducted in adult patients with locally advanced or metastatic UC who had previously received platinum-based chemotherapy and a PD-1/L1 inhibitor, comparing Padcev with chemotherapy.

The results showed,With a median follow-up of 11.1 months, compared to the chemotherapy group, the Padcev group showed a significant extension in overall survival (median OS: 12.88 months vs 8.97 months; HR=0.70; 95% CI: 0.56, 0.89; p=0.001) and a significant extension in progression-free survival (median PFS: 5.55 months vs 3.71 months; HR=0.62; p<0.001).

Based on the results of this trial, clinicians will have a treatment option that has demonstrated an overall survival (OS) advantage compared to chemotherapy for patients with advanced UC who have previously received platinum-based chemotherapy and immunotherapy. (Bioon.com)