Drugs / PF-05280586
PF-05280586
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | US (FDA) | — | — | 2018-12-02 | “PF-05280586 has been accepted for review by the FDA, the BsUFA goal date for a decision by the FDA is in second-quarter 2019.” pfizer.com ↗ |
Trials 2
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 21 trial | ||||||
| Phase 2 | NCT01526057 | Mar 2012 → Aug 2013 | rheumatoid arthritis | Pfizer | Completed | No outcome recorded |
| Phase 31 trial · 1 met primary | ||||||
| Phase 3 | NCT02213263 | Sep 2014 → Oct 2017 | follicular lymphoma | Pfizer | Completed | Met primary |
News releases announcing trial results or a regulatory action · 4
| Date | Issuer | Release |
|---|---|---|
| 2020-04-02 | Pfizer | Regulatory Pfizer Receives European Approval for Oncology Biosimilar, RUXIENCE™ (rituximab) pfizer.com ↗
The EC approval is based on a comprehensive data package which demonstrated biosimilarity of RUXIENCE to the reference product. |
| 2020-01-31 | Pfizer | Regulatory Pfizer Receives Positive CHMP Opinion for Oncology Biosimilar, RUXIENCE™ (rituximab) pfizer.com ↗ |
| 2018-12-02 | Pfizer | Results Pfizer Presents Positive 26-Week Data For PF-05280586, A Potential Biosimilar To Rituximab, At The American Society Of Hematology Annual Meeting pfizer.com ↗
26-week data from the ongoing 52-week REFLECTIONS B328-06 study (n=394) demonstrated no clinically meaningful differences in efficacy, in terms of ORR at Week 26, between PF-05280586 and MabThera, for the first-line treatment of patients with CD20-positive, low tumor burden, follicular lymphoma (LTB-FL). |
| 2018-01-24 | Pfizer | Results Pfizer Announces Positive Top-Line Results For Potential Biosimilar To Rituxan®/MabThera® pfizer.com ↗
Pfizer Inc. today announced that REFLECTIONS B3281006, a comparative safety and efficacy study of PF-05280586 versus MabThera ® (rituximab-EU), met its primary endpoint. |
All press releases naming this drug 5 releases
Evidence & citations 4 cited values
Every value below carries the sentence it was read from. 3 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | PF-05280586 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02213263 ↗ |
| Known as | rituximab-Pfizer | “PF-05280586 (rituximab-Pfizer) concentrate for solution for infusion 375mg/m2 administered via IV infusion on Days 1, 8, 15, and 22” NCT02213263 ↗ |
| Known as | Ruxience | “OBJECTIVE: This comparative 52-week clinical study evaluated the efficacy, safety, immunogenicity, pharmacokinetics (PK), and pharmacodynamics (PD) of PF-05280586 (Ruxience™ [a...” PMID 31820339 ↗ Apr 2020 |
| Route | Intravenous | “PF-05280586 (rituximab-Pfizer) concentrate for solution for infusion 375mg/m2 administered via IV infusion on Days 1, 8, 15, and 22” NCT02213263 ↗ |