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▎The content team editor of WuXi AppTec today, Seagen and Astellas jointly announced that the US FDA has approved the company’s antibody-conjugated drug (ADC) Padcev (enfortumab vedotin-ejfv) for extended indications for the treatment of previous Patients with locally advanced or metastatic urothelial cancer who have received at least one pre-treatment, but are not suitable for receiving cisplatin-containing chemotherapy
.
The press release states that this is the first therapy approved by the FDA for this patient group
.
The FDA also converted the previous accelerated approval into full approval based on the data from Padcev's Phase 3 clinical trial EV-301
.
In 2020, approximately 580,000 people worldwide will be diagnosed with bladder cancer
.
Urothelial cancer accounts for 90% of all bladder cancers and can also occur in the renal pelvis, ureter, and urethra
.
The press release pointed out that 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 disease recurrence, 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
.
Based on the response rate data, this therapy received accelerated approval from the US FDA in December 2019 to treat patients with locally advanced or metastatic urothelial cancer
.
These patients have been treated with cisplatin-containing chemotherapy and PD-1/PD-L1 inhibitors
.
The approval of the extended indications is based on the positive results obtained by Padcev in the second cohort of patients in the pivotal phase 2 clinical trial EV-201
.
The results of the trial showed that in patients with locally advanced or metastatic urothelial cancer who had received PD-1/PD-L1 inhibitor treatment and were not suitable for cisplatin-containing chemotherapy, when the median follow-up time was 16 months, they received Padcev The objective response rate of treated patients was 51% (95% CI: 39.
8, 61.
3)
.
The median duration of response was 13.
8 months (95% CI: 6.
4, not yet reached)
.
The conversion of Padcev’s accelerated approval to full approval is based on positive data from the Phase 3 clinical trial EV-301
.
This data has been published in the New England Journal of Medicine.
Compared with chemotherapy, Padcev extended the patient's overall survival by 3.
9 months
.
"For locally advanced or metastatic patients who have received immunotherapy but cannot receive cisplatin chemotherapy, Padcev is the first FDA-approved therapy
.
" said Dr.
Roger Dansey, Chief Medical Officer of Seagen, "because of the FDA's real-time oncology review Evaluation procedures, we can bring it to these patients as soon as possible, they have limited treatment options due to age or comorbidities
.
"Reference: [1] US FDA Grants Regular Approval and Expands Indication for PADCEV® (enfortumab vedotin-ejfv) for Patients with Locally Advanced or Metastatic Urothelial Cancer.
Retrieved July 9, 2021, from https:// /news/home/20210709005414/en Note: This article aims to introduce the progress of medical and health research, not a recommendation for treatment plans
.
If you need guidance on treatment plans, please go to a regular hospital
.
.
The press release states that this is the first therapy approved by the FDA for this patient group
.
The FDA also converted the previous accelerated approval into full approval based on the data from Padcev's Phase 3 clinical trial EV-301
.
In 2020, approximately 580,000 people worldwide will be diagnosed with bladder cancer
.
Urothelial cancer accounts for 90% of all bladder cancers and can also occur in the renal pelvis, ureter, and urethra
.
The press release pointed out that 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 disease recurrence, 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
.
Based on the response rate data, this therapy received accelerated approval from the US FDA in December 2019 to treat patients with locally advanced or metastatic urothelial cancer
.
These patients have been treated with cisplatin-containing chemotherapy and PD-1/PD-L1 inhibitors
.
The approval of the extended indications is based on the positive results obtained by Padcev in the second cohort of patients in the pivotal phase 2 clinical trial EV-201
.
The results of the trial showed that in patients with locally advanced or metastatic urothelial cancer who had received PD-1/PD-L1 inhibitor treatment and were not suitable for cisplatin-containing chemotherapy, when the median follow-up time was 16 months, they received Padcev The objective response rate of treated patients was 51% (95% CI: 39.
8, 61.
3)
.
The median duration of response was 13.
8 months (95% CI: 6.
4, not yet reached)
.
The conversion of Padcev’s accelerated approval to full approval is based on positive data from the Phase 3 clinical trial EV-301
.
This data has been published in the New England Journal of Medicine.
Compared with chemotherapy, Padcev extended the patient's overall survival by 3.
9 months
.
"For locally advanced or metastatic patients who have received immunotherapy but cannot receive cisplatin chemotherapy, Padcev is the first FDA-approved therapy
.
" said Dr.
Roger Dansey, Chief Medical Officer of Seagen, "because of the FDA's real-time oncology review Evaluation procedures, we can bring it to these patients as soon as possible, they have limited treatment options due to age or comorbidities
.
"Reference: [1] US FDA Grants Regular Approval and Expands Indication for PADCEV® (enfortumab vedotin-ejfv) for Patients with Locally Advanced or Metastatic Urothelial Cancer.
Retrieved July 9, 2021, from https:// /news/home/20210709005414/en Note: This article aims to introduce the progress of medical and health research, not a recommendation for treatment plans
.
If you need guidance on treatment plans, please go to a regular hospital
.