FDA limits use of atezolizumab and pembrolizumab in urothelial carcinoma

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By: scienterrific | Last updated: 19 June 2018 | In: US FDA Onc\Haem Approvals, Genitourinary Cancer, Oncology, Immunotherapy, Translational Research

Article Keywords

pembrolizumab, mUCC, Merck, urothelial carcinoma, Roche, chemotherapy, atezolizumab, cisplatin, FDA, Oncology, carboplatin, Keytruda, PD-1, MSD, PD-L1, Genentech, Tecentriq

On June 19, the FDA limited the use of atezolizumab and pembrolizumab for the treatment of locally advanced or metastatic urothelial cancer patients ineligible for cisplatin-containing therapy.

On May 18, the US FDA already issued a safety alert about the decreased survival in studies with pembrolizumab (Keytruda®) and atezolizumab (Tecentriq®) as single agent first-line therapy for patients with metastatic urothelial cancer (mUCC) and low expression of the programmed death ligand 1 (PD-L1) protein.

Label pembrolizumab for locally advanced or metastatic urothelial carcinoma (mUCC):
- FDA recommendation: ineligible for cisplatin-based chemotherapy and a CPS (combined positive score: PD-L1 level expression on tumour and immune cells)≥10, or;
- Ineligible for cisplatin-based chemotherapy regardless of PD-L1 expression, or;
- Failure on prior platinum-based chemotherapy;
- Progression ≤12 months after (neo)adjuvant platinum-based chemotherapy.

Label atezolizumab for locally advanced or metastatic urothelial carcinoma (mUCC):
- FDA recommendation: ineligibility for cisplatin-based chemotherapy and a tumour PD-L1 expression (PD-L1 stained tumour-infiltrating immune cells [IC] covering ≥ 5% of the tumor area);
- Ineligibility for cisplatin-based chemotherapy regardless of tumour PD-L1 expression;
- Disease progression during or following platinum-containing chemotherapy;
- Disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.

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Disclaimer

This article is not medical advice. Patients should seek personal assessment by a licenced specialist. Physicians are recommended to read the full publication(s) as cited in the article before making medical decisions. This article does not supersede nor replace the published article(s).

Non-Sponsored Content

FDA limits use of atezolizumab and pembrolizumab in urothelial carcinoma

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