Courier reduces the mortality of bladder cancer patients by 30%!

▎The content team editor of WuXi AppTec recently, Astellas Pharma and Seagen jointly announced that the European Medicines Agency (EMA) Committee for Human Medicines (CHMP) has issued positive opinions and recommends the approval of antibody-conjugated drugs (ADC) Padcev (enfortumab vedotin) is used as a monotherapy for the treatment of adult patients with locally advanced or metastatic urothelial cancer.
These patients have previously received platinum-containing chemotherapy and PD-1/L1 inhibitor treatment
.

The press release states that if approved, enfortumab vedotin will become the first therapy approved by the European Commission (EC) for this patient group
.

 Urothelial cancer is the most common type of bladder cancer, accounting for about 90% of all bladder cancers.
It can also occur in the renal pelvis, ureter, and urethra
.

Globally, approximately 73,000 new cases of bladder cancer and 212,000 deaths are reported every year
.

About half of patients with advanced bladder cancer cannot receive cisplatin-containing chemotherapy.
They usually receive first-line immunotherapy.
However, if there is no response to immunotherapy or the disease recurs, their treatment options are limited and the prognosis is poor
.

Padcev is an antibody conjugate drug that conjugates anti-Nectin-4 monoclonal antibody and microtubule inhibitor
.

Nectin-4 protein is a cell adhesion molecule highly expressed in urothelial carcinoma
.

After Padcev binds to tumor cells expressing Nectin-4, the anti-tumor drug methyl auristatin E (MMAE) will be internalized and released into the cells, causing the cells to stop multiplying and apoptosis
.

Based on its positive response rate data, this therapy was approved by the U.
S.
FDA in December 2019 to treat locally advanced or metastatic urothelial cancer that has previously received chemotherapy containing cisplatin and PD-1/PD-L1 inhibitors.
Patient
.

 The positive opinion of CHMP is based on the positive results obtained in a phase 3 clinical trial
.

The scheduled interim analysis showed that among the patients who received chemotherapy and PD-1/PD-L1 inhibitor therapy (n=608), the risk of death was reduced by about 30% in patients who received Padcev, and the median overall survival (OS ) Was 12.
88 months (n=301), which was 3.
91 months longer than the chemotherapy control group (n=307, 8.
97 months) (HR=0.
70, 95% CI: 0.
56-0.
89, p=0.
001)
.

Related results have been published in the "New England Journal of Medicine"
.

Dr.
Ahsan Arozullah, Vice President of Astellas Medical Sciences-Oncology, said: “Patients with advanced bladder cancer have few treatment options after platinum-containing chemotherapy and immunotherapy
.

The positive opinion of CHMP is an important step in our efforts to expand the use of enfortumab vedotin
.

"Reference: [1] Astellas and Seagen Receive Positive CHMP Opinion for Padcev™ (enfortumab vedotin) in Locally Advanced or Metastatic Urothelial Cancer.
Retrieved December 17, 2021, from https:// astellas-and-seagen-receive-positive-chmp-opinion-for-padcev-enfortumab-vedotin-in-locally-advanced-or-metastatic-urothelial-cancer-301447279.
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