FDA grants accelerated approval to retifanlimab-dlwr for metastatic or recurrent locally advanced Merkel cell carcinoma
Regulatory approval: On March 22, 2023, the FDA granted accelerated approval to retifanlimab-dlwr (Zynyz; Incyte) for adults with metastatic or recurrent locally advanced Merkel cell carcinoma. The decision was based on PODIUM-201 (NCT03599713), a single-arm study in 65 previously untreated patients with advanced disease, reporting an objective response rate of 52% (95% CI, 40–65) and complete responses in 18%.
FDA accelerated approval: retifanlimab-dlwr in Merkel cell carcinoma
Type: Regulatory approval (accelerated approval)
Agency/date: FDA, 2023-03-22
Indication: Adults with metastatic or recurrent locally advanced Merkel cell carcinoma (MCC).
Evidence base
Approval was supported by PODIUM-201 (NCT03599713), an open-label, multiregional, single-arm trial in 65 patients with metastatic or recurrent locally advanced MCC who had not received prior systemic therapy for advanced disease.
Primary efficacy endpoints: Objective response rate (ORR) and duration of response (DOR) by independent central review per RECIST v1.1.
Efficacy results:
- ORR: 52% (95% CI, 40–65)
- Complete response rate: 18%
- DOR: 26 patients (76%) had DOR ≥6 months; 21 (62%) had DOR ≥12 months
Safety
Safety was evaluated in 105 patients with MCC. The most common (≥10%) adverse reactions were fatigue, musculoskeletal pain, pruritus, diarrhea, rash, pyrexia, and nausea. Serious adverse reactions occurred in 22% of patients.
Dosing (label)
Recommended dose: 500 mg IV over 30 minutes every 4 weeks until disease progression, unacceptable toxicity, or up to 24 months.
The application received priority review, fast track, and orphan drug designation.