Product Description
PF-05280586 is a monoclonal antibody (mAb) that is in development as a potential biosimilar to Rituxan/MabThera. Rituxan/MabThera is indicated for the treatment of patients with certain types of CD20-positive non-Hodgkin lymphoma; CD20-positive chronic lymphocytic leukemia; rheumatoid arthritis; granulomatosis with polyangiitis and microscopic polyangiitis; and other region-specific indications. (Sourced from: https://www.pfizer.com/news/press-release/press-release-detail/pfizer_presents_positive_26_week_data_for_pf_05280586_a_potential_biosimilar_to_rituximab_at_the_american_society_of_hematology_annual_meeting)
Mechanisms of Action: TNF Inhibitor
Novel Mechanism: No
Modality: Antibody
Route of Administration: Intravenous
FDA Designation: *
Approval Status: Not Approved
Approved Countries: None
Approved Indications: None
Known Adverse Events: None
Company: Pfizer
Company Location: Eastern America
Company CEO: Albert Bourla
Additional Commercial Interests: None
Clinical Description
Countries in Clinic:
Active Clinical Trial Count:
Recent & Upcoming Milestones
Highest Development Phases
Phase 3: Follicular Lymphoma|Acute Lymphoid Leukemia|Acute Myeloid Leukemia|Myelodysplastic Syndrome|Precursor Cell Lymphoblastic Leukemia-Lymphoma|Preleukemia
Phase 2: Arthritis, Rheumatoid|Lymphocytic Chronic B-Cell Leukemia|Histiocytosis, Langerhans-Cell|Hodgkin Lymphoma|Lymphoma, Non-Hodgkin|Precursor B-Cell Lymphoblastic Leukemia-Lymphoma|Chronic Lymphoid Leukemia|Lymphoma, B-Cell|Anemia, Refractory, with Excess of Blasts|Myeloid, Accelerated Leukemia|Acute Lymphoid Leukemia|Biphenotypic Acute Leukemia|Chronic Myelomonocytic Leukemia|Myelogenous, Chronic, BCR-ABL Positive Leukemia|Acute Myelomonocytic Leukemia|Preleukemia|Chronic Myeloid Leukemia|Acute Monocytic Leukemia|Myelodysplastic Syndrome|Acute Myeloid Leukemia|Juvenile Myelomonocytic Leukemia,|T-Cell Cutaneous Lymphoma|Precursor Cell Lymphoblastic Leukemia-Lymphoma|Myelodysplastic-Myeloproliferative Diseases|Inflammation|Follicular Lymphoma|B-Cell Leukemia|Myeloproliferative Disorders|Diffuse Large B-Cell Lymphoma|Leukemia, Plasma Cell|Multiple Myeloma
Phase 1: Acute Myelomonocytic Leukemia|Leukemia, Plasma Cell|Chronic Myelomonocytic Leukemia|Myeloproliferative Disorders|Juvenile Myelomonocytic Leukemia,|Myelogenous, Chronic, BCR-ABL Positive Leukemia|Lymphoma, B-Cell|Precursor Cell Lymphoblastic Leukemia-Lymphoma|Precursor B-Cell Lymphoblastic Leukemia-Lymphoma|Lymphoma, Non-Hodgkin|Acute Myeloid Leukemia|Lymphocytic Chronic B-Cell Leukemia|Chronic Lymphoid Leukemia|Chronic Myeloid Leukemia|Anemia, Aplastic|Acute Lymphoid Leukemia|Multiple Myeloma|Preleukemia|Blast Crisis|Myelodysplastic Syndrome|Acute Monocytic Leukemia|Adenocarcinoma|B-Cell Marginal Zone Lymphoma|Myeloid, Accelerated Leukemia|T-Cell Cutaneous Lymphoma|Breast Cancer|Mycosis Fungoides|Diffuse Large B-Cell Lymphoma|Biphenotypic Acute Leukemia
Trial ID |
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
Latest Trial Update Date |
Data Updated |
|---|---|---|---|---|---|---|---|---|
ACTRN12622000306718p |
2006-7041-83/hah | N/A |
Not yet recruiting |
Dental Caries|Intestinal Diseases |
2022-02-28 |
|||
NCT01643928 |
REFLECTIONS B328-04 | N/A |
Completed |
Arthritis, Rheumatoid |
2016-03-14 |
2019-03-19 |
Primary Completion Date|Start Date |
|
NCT05052528 |
UCDCC#299 | P1 |
Recruiting |
Diffuse Large B-Cell Lymphoma |
2025-05-15 |
2024-05-14 |
||
NCT02960646 |
NCI-2016-01915 | P1 |
Completed |
Myelodysplastic Syndrome|Acute Myelomonocytic Leukemia|Acute Myeloid Leukemia|Lymphocytic Chronic B-Cell Leukemia|Chronic Myelomonocytic Leukemia|Lymphoma, B-Cell|Acute Monocytic Leukemia|Multiple Myeloma|Chronic Myeloid Leukemia|Lymphoma, Non-Hodgkin|Preleukemia|Precursor Cell Lymphoblastic Leukemia-Lymphoma|Myeloproliferative Disorders|Leukemia, Plasma Cell|Precursor B-Cell Lymphoblastic Leukemia-Lymphoma|Myelogenous, Chronic, BCR-ABL Positive Leukemia|Chronic Lymphoid Leukemia|Anemia, Aplastic|Juvenile Myelomonocytic Leukemia,|Acute Lymphoid Leukemia|Blast Crisis |
2023-02-13 |
2023-02-18 |
Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments|Trial Status |
|
NCT03432741 |
MC1689 | P1 |
Terminated |
Breast Cancer|T-Cell Cutaneous Lymphoma|Lymphoma, Non-Hodgkin|B-Cell Marginal Zone Lymphoma|Adenocarcinoma|Mycosis Fungoides |
2022-08-26 |
2025-05-28 |
Primary Completion Date|Primary Endpoints|Treatments |
|
NCT01619761 |
NCI-2012-02071 | P1 |
Unknown status |
Chronic Myeloid Leukemia|Myeloid, Accelerated Leukemia|Leukemia, Plasma Cell|Lymphocytic Chronic B-Cell Leukemia|Chronic Lymphoid Leukemia|Lymphoma, B-Cell|Acute Myeloid Leukemia|Acute Lymphoid Leukemia|Lymphoma, Non-Hodgkin|Multiple Myeloma|Myelogenous, Chronic, BCR-ABL Positive Leukemia|Precursor Cell Lymphoblastic Leukemia-Lymphoma|Biphenotypic Acute Leukemia|Precursor B-Cell Lymphoblastic Leukemia-Lymphoma|Myelodysplastic Syndrome|Preleukemia |
2021-11-01 |
2022-02-02 |
Primary Endpoints|Treatments|Trial Status |
|
NCT02779283 |
IRB00011766 | P1 |
Completed |
Acute Myeloid Leukemia|Acute Lymphoid Leukemia|Precursor Cell Lymphoblastic Leukemia-Lymphoma |
2018-04-19 |
2025-02-07 |
Primary Endpoints|Treatments |
|
NCT02727803 |
NCI-2016-00584 | P2 |
Recruiting |
Preleukemia|Precursor Cell Lymphoblastic Leukemia-Lymphoma|Myeloproliferative Disorders|B-Cell Leukemia|Acute Lymphoid Leukemia|Myelodysplastic-Myeloproliferative Diseases|Acute Monocytic Leukemia|Acute Myelomonocytic Leukemia|Myeloid, Accelerated Leukemia|Acute Myeloid Leukemia|Juvenile Myelomonocytic Leukemia,|Chronic Myelomonocytic Leukemia|Multiple Myeloma|Precursor B-Cell Lymphoblastic Leukemia-Lymphoma|Lymphoma, B-Cell|Myelodysplastic Syndrome|Anemia, Refractory, with Excess of Blasts|Leukemia, Plasma Cell|Chronic Myeloid Leukemia|Biphenotypic Acute Leukemia|Myelogenous, Chronic, BCR-ABL Positive Leukemia|Lymphoma, Non-Hodgkin|Chronic Lymphoid Leukemia |
2027-05-31 |
2025-05-10 |
Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments |
|
NCT06834373 |
MC230813 | P2 |
Recruiting |
Follicular Lymphoma|Diffuse Large B-Cell Lymphoma|Inflammation|T-Cell Cutaneous Lymphoma|Lymphoma, Non-Hodgkin |
2027-03-03 |
2025-04-05 |
Primary Endpoints|Start Date|Treatments|Trial Status |
|
NCT03096782 |
NCI-2018-01236 | P2 |
Completed |
Acute Lymphoid Leukemia|Juvenile Myelomonocytic Leukemia,|Myelogenous, Chronic, BCR-ABL Positive Leukemia|Myeloid, Accelerated Leukemia|Myelodysplastic Syndrome|Chronic Myelomonocytic Leukemia|Acute Myeloid Leukemia|Precursor B-Cell Lymphoblastic Leukemia-Lymphoma|Acute Monocytic Leukemia|Lymphocytic Chronic B-Cell Leukemia|Chronic Myeloid Leukemia|Preleukemia|Biphenotypic Acute Leukemia|Hodgkin Lymphoma|Precursor Cell Lymphoblastic Leukemia-Lymphoma|Histiocytosis, Langerhans-Cell|Anemia, Refractory, with Excess of Blasts|Chronic Lymphoid Leukemia|Acute Myelomonocytic Leukemia|Lymphoma, B-Cell|Lymphoma, Non-Hodgkin |
2022-09-20 |
2023-06-30 |
Primary Endpoints |
|
2012-003223-38 |
REFLECTIONS B328-04 | P2 |
Completed |
Arthritis, Rheumatoid |
2016-03-14 |
2022-03-13 |
Treatments |
|
2011-002896-40 |
2011-002896-40 | P2 |
Completed |
Arthritis, Rheumatoid |
2014-05-07 |
2022-03-13 |
Treatments |
|
NCT01526057 |
REFLECTIONS | P2 |
Completed |
Arthritis, Rheumatoid |
2013-08-13 |
2019-03-19 |
Treatments |
|
NCT05457556 |
ASCT2031 | P3 |
Active, not recruiting |
Acute Myeloid Leukemia|Precursor Cell Lymphoblastic Leukemia-Lymphoma|Acute Lymphoid Leukemia|Myelodysplastic Syndrome|Preleukemia |
2026-06-30 |
2025-05-06 |
Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments|Trial Status |
|
NCT02003222 |
NCI-2013-02229 | P3 |
Active, not recruiting |
Precursor Cell Lymphoblastic Leukemia-Lymphoma|Acute Lymphoid Leukemia |
2023-06-23 |
2025-02-07 |
Primary Endpoints|Treatments |
|
2014-000132-41 |
2014-000132-41 | P3 |
Completed |
Follicular Lymphoma |
2018-04-19 |
2022-03-13 |
Treatments |
|
JapicCTI-152823 |
JapicCTI-152823 | P3 |
Unknown |
Follicular Lymphoma |
2018-04-19 |
|||
NCT02213263 |
REFLECTIONS B328-06 | P3 |
Completed |
Follicular Lymphoma |
2017-10-23 |
2019-03-20 |
Recent News Events
Date |
Type |
Title |
|---|---|---|
|
01/01/2006 |
PubMed |
Rituximab. |
|
04/01/2022 |
PubMed |
Analytical similarity as base for rituximab biosimilars in lymphoid malignancies in the clinic: a PF-05280586 case study. |
|
07/01/2021 |
PubMed |
Factors Influencing Infusion-Related Reactions Following Dosing of Reference Rituximab and PF-05280586, a Rituximab Biosimilar. |
|
04/02/2020 |
News Article |
Pfizer Receives European Approval for Oncology Biosimilar, RUXIENCE™ (rituximab) |
|
01/31/2020 |
News Article |
Pfizer Receives Positive CHMP Opinion for Oncology Biosimilar, RUXIENCE™ (rituximab) |
|
07/23/2019 |
News Article |
FDA Approves Pfizer's Biosimilar, RUXIENCE™ (rituximab-pvvr), for Certain Cancers and Autoimmune Conditions |
|
01/29/2019 |
News Article |
PFIZER REPORTS FOURTH-QUARTER AND FULL-YEAR 2018 RESULTS |