Padcev fda approval date?

Padcev FDA Approval Date and Timeline

Padcev, also known as enfortumab vedotin, is an anti-vascular endothelial growth factor A (VEGF-A) antibody drug conjugate used in the treatment of urothelial cancer.

What is Padcev's FDA Approval Status?

Padcev was granted accelerated approval by the FDA in December 2019 for the treatment of adult patients with locally advanced or metastatic urothelial cancer who have previously received a programmed death-ligand 1 (PD-L1) inhibitor and platinum-containing chemotherapy.

Padcev FDA Approval Timeline

- December 18, 2019: FDA approved Padcev for the treatment of adult patients with locally advanced or metastatic urothelial cancer who have previously received a PD-L1 inhibitor and platinum-containing chemotherapy [1].

How Long Does Padcev's Exclusivity Last?

Padcev's exclusivity period is expected to last until 2036, given the 2034 patent expiry [DrugPatentWatch.com 2021][2].

What are the Side Effects of Padcev?

The most common adverse reactions (≥20%) were peripheral neuropathy, alopecia, fatigue, decreased appetite, and nausea [3].

References

[1] FDA. FDA Approves Padcev to Treat Rare Genitourinary Cancer. December 18, 2019. Available at: https://www.fda.gov/news-events/press-announcements/fda-approves-padcev-treat-rare-genitourinary-cancer\
[2] DrugPatentWatch.com. Padcev. 2021. Available at: https://www.drugpatentwatch.com/Padcev
[3] Janssen Biotech, Inc. PADCEV. 2023. Available at: https://www.padcev.com/patient/important-safety-information