Drugs / PF-06439535
Trials 2
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1 | NCT04126044 | Jan → Jul 2021 | — | Pfizer | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 1 | NCT02031991 | Jan → Aug 2014 | — | Pfizer | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 3
| Date | Issuer | Release |
|---|---|---|
| 2019-06-28 | Pfizer | Regulatory Pfizer Receives U.S. FDA Approval for Its Oncology Biosimilar, ZIRABEV™ (bevacizumab-bvzr) pfizer.com ↗
Pfizer Inc. (NYSE:PFE) today announced the United States (U.S.) Food and Drug Administration(FDA) has approved ZIRABEV™ (bevacizumab-bvzr), a biosimilar to Avastin ® (bevacizumab), 1 for the treatment of five types of cancer: |
| 2018-12-14 | Pfizer | Regulatory Pfizer Receives Positive CHMP Opinion for Oncology Biosimilar, ZIRABEV™ (bevacizumab) pfizer.com ↗
Pfizer Inc. (NYSE:PFE) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion, recommending marketing authorization for ZIRABEV ™ (bevacizumab), a potential biosimilar to Avastin (bevacizumab). |
| 2017-07-24 | Pfizer | Results Pfizer Announces Positive Top-Line Results from the Comparative REFLECTIONS B7391003 Study for PF-06439535, a Potential Biosimilar to Avastin®1 (bevacizumab) pfizer.com ↗
The trial demonstrated equivalence in the primary endpoint of objective response rate (ORR) of PF-06439535 versus Avastin, taken in combination with carboplatin/paclitaxel, for the first line treatment of patients with advanced non-squamous non-small cell lung cancer (NSCLC). |
All press releases naming this drug 3 releases
Evidence & citations 2 cited values
Every value below carries the sentence it was read from. 2 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | PF-06439535 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02031991 ↗ |
| Route | Intravenous | “administered intravenously” NCT04126044 ↗ |