Spectrum Pharmaceuticals’ Rolvedon (eflapegrastim-xnst) Receives the US FDA’s Approval for Adult Patients with Non-Myeloid Malignancies
Shots:
- The approval was based on the P-III (ADVANCE) trial in 406 patients and (RECOVER) trials in 237 patients to evaluate eflapegrastim vs pegfilgrastim to reduce the risk of CT-induced neutropenia for breast cancer. The product is expected to be available in Q4’22
- The results from both trials showed that (15.8% vs 24.3% & 20.3% vs 23.5%) had sev. neutropenia during cycle 1, patients had toxicity lasting 1/2/3Days were 12% & 11%/3% & 8%/1% & 2% vs 15% & 17%/8% & 3%/1% & 3% while 42% reduction in mean duration of sev. neutropenia during cycle 1 in (ADVANCE) trial; relative risk reduction 8.5% vs 34.9%
- Mean duration of sev. neutropenia in cycle 1 was 0.20 ± 0.503 and 0.31 days vs 0.35 ± 0.683 and 0.39 days, AEs were consistent with prior results
Ref: Buisnesswire | Image: Spectrum Pharmaceuticals
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