Fludarabine
Regulatory milestones approvals, filings & regulatory actions · 3 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansion | US (FDA) | FLUDARABINE PHOSPHATE | — | 2024-11-19 | fda.gov ↗ |
| Label expansion | US (FDA) | FLUDARA | — | 2003-08-01 | fda.gov ↗ |
| Approved | US (FDA) | FLUDARA | — | 1991-04-18 | fda.gov ↗ |
Trials 452 · started per year
News releases announcing trial results or a regulatory action · 23
| Date | Issuer | Release |
|---|---|---|
| 2025-12-08 | GeoVax, Inc. | Results GeoVax Announces JCO Oncology Advances Publication Highlighting Favorable Safety and Evidence of Disease Stability of Gedeptin® in Recurrent Head & Neck Cancer geovax.com ↗
Three of eight patients (37.5%) in this cohort of patients with end-stage disease achieved stable disease. |
| 2025-04-30 | Senti Biosciences | Results SENTI-202 CD33 OR FLT3 NOT EMCN Logic-Gated Gene Circuit Components Selectively Target AML while Protecting Human HSC/HPCs from Off-Tumor Toxicity in a Humanized Mouse Model sentibio.com ↗
The NOT EMCN inhibitory CAR (iCAR) protects hematopoietic stem and progenitors (HSC/HPCs) from off-tumor toxicity (even if the healthy cells are FLT3+/CD33+), which is a major technological advancement that could enhance safety and hematopoietic recovery in patients. |
| 2024-06-14 | Syndax Pharmaceuticals | Results Syndax Presents Updated Positive Data from BEAT AML and AUGMENT-102 Phase 1/2 Combination Trials of Revumenib in Patients with Acute Leukemias at EHA 2024 Congress syndax.com ↗
52% CRc (14 of 27 pts) observed in AUGMENT-102 trial of revumenib in combination with fludarabine-cytarabine in acute leukemia patients with R/R mNPM1, NUP98r or KMT2Ar |
| 2023-12-11 | Senti Biosciences | Results Calibrated Release IL15-Expressing Bivalent CD33 and/or FLT3 Logic Gated Gene Circuit CAR-NK Cell Therapy (from SENTI-202 gene circuit) in Venetoclax Resistant Patient Derived Xenograft Acute Myeloid Leukemia Models sentibio.com ↗
CD33/FLT3 CAR (crIL15) NK cell therapy demonstrated significant therapeutic efficacy against VEN-R AML cells in vitro and in vivo. |
| 2023-12-11 | Syndax Pharmaceuticals | Results Syndax Announces Positive Data for Revumenib in Patients with Acute Leukemias from the BEAT AML, SAVE AML and AUGMENT-102 Phase 1 Combination Trials syndax.com ↗
33% CRc observed in AUGMENT-102 trial of revumenib in combination with fludarabine-cytarabine in pediatric R/R mNPM1, NUP98r and KMT2Ar AML |
| 2023-10-31 | Senti Biosciences | Results NOT gate gene circuits expand the range of tumor-associated antigens addressable by CAR-NK and -T cell therapies sentibio.com ↗
NOT gated CAR-T construct achieves robust protection |
| 2023-06-13 | Medexus Pharma, Inc. | Results Medexus Highlights Data on Trecondyv (Treosulfan) Presented at MDS 2023 medexus.com ↗
The study found that reduced toxicity conditioning ( RTC ) with fludarabine-treosulfan ( FT ) improves transplant outcomes in myeloablative conditioning ( MAC ) ineligible patients with myelodysplastic syndrome ( MDS ) who receive graft-vs-host disease ( GVHD ) prophylaxis with dual T-cell depletion ( TCD ). |
| 2023-04-17 | Senti Biosciences | Results Preclinical development of SENTI-202, an off-the-shelf Logic Gated CAR-NK cell therapy, for the treatment of CD33/FLT3+ hematologic malignancies including AML sentibio.com ↗
The CD33/FLT3 OR Gate activating CAR successfully enables the targeting of primary AML blasts, LSCs, and MDS cells, while the NOT Gate decreases the killing of HSCs while preserving their function by an inhibitory CAR that detects a protective antigen, EMCN, found in healthy HSCs. |
| 2022-12-10 | Senti Biosciences | Results SENTI-202, a Selective, Off-the-Shelf, Preclinical CAR-NK Cell Therapy with CD33 and/or FLT3 Activating CAR, Healthy Cell Protection from Endomucin (EMCN) Inhibitory CAR and Calibrated Release IL-15 for Hematologic Malignancies Including AML sentibio.com ↗
SENTI-202 Possesses Significant Preclinical Anti-Tumor Activity |
| 2021-12-15 | Senti Biosciences | Results FLT3 OR CD33 NOT EMCN Logic Gated CAR NK Cell Therapy (SENTI 202) for Precise Targeting of AML sentibio.com ↗
SENTI-202: AML Blasts & LSC Clearance While Sparing Healthy HSCs |
| 2019-12-09 | Janssen Research & Development, LLC | Results IMBRUVICA® (ibrutinib) Combination Therapy Data From Two Studies and Long-Term Integrated Analysis Presented at ASH 2019 Show Efficacy and Safety in First-Line Treatment of Chronic Lymphocytic Leukemia jnj.com ↗
Results from a 48-month follow-up analysis of the Phase 3 E1912 clinical study reported a statistically significant difference in PFS and OS for IMBRUVICA®plus rituximab compared to a standard chemoimmunotherapy regimen of fludarabine, cyclophosphamide and rituximab (FCR). |
| 2019-12-07 | AbbVie | Results Extended Follow-up Phase 3 Data Underscore Sustained Efficacy and Safety of IMBRUVICA® (ibrutinib) in the Treatment of Chronic Lymphocytic Leukemia (CLL) abbvie.com ↗
These results demonstrated the benefits of IMBRUVICA ® (ibrutinib) plus rituximab compared to a standard chemoimmunotherapy regimen of fludarabine, cyclophosphamide and rituximab (FCR) for previously untreated patients with CLL aged 70 years or younger. |
| 2018-12-04 | AbbVie | Results IMBRUVICA® (ibrutinib) Combination Regimen Significantly Improved Survival Versus the Chemoimmunotherapy FCR (Fludarabine, Cyclophosphamide and Rituximab) in Previously Untreated and Younger Chronic Lymphocytic Leukemia (CLL) Patients; Late-Breaking Phase 3 Data at ASH 2018 abbvie.com ↗
This interim analysis showed that IMBRUVICA plus rituximab significantly prolonged progression-free survival (PFS), the primary endpoint of the study, compared to FCR, with a 65 percent reduction in risk of progression or death. |
| 2017-03-14 | Gilead Sciences | Results Kite Pharma Highlights Publication from the National Cancer Institute Demonstrating Durable Complete Remissions in Patients with Relapsed/Refractory Non-Hodgkin Lymphoma Following Low Dose Conditioning Chemotherapy and Anti-CD19 CAR T-Cell Therapy gilead.com ↗
Objective responses (OR) were seen in 73 percent of patients, and complete remissions (CR) were observed in 55 percent of patients. |
| 2015-12-07 | Karyopharm Therapeutics Inc | Results Karyopharm Therapeutics Presents Positive Clinical Data on the Activity of Selinexor in Combination with Other Anticancer Agents across Multiple Hematologic Malignancies at the 2015 American Society of Hematology (ASH) Annual Meeting karyopharm.com ↗
with fludarabine and cytarabine in pediatric patients with relapsed or refractory acute leukemias |
| 2015-06-12 | Novartis Pharmaceuticals | Results Novartis drug Arzerra® improved median progression-free survival by 54% in patients with relapsed chronic lymphocytic leukemia novartis.com ↗
Arzerra significantly improved PFS when added to fludarabine + cyclophosphamide (median 28.9 mos vs 18.8 mos) after initial treatment stopped working |
| 2015-04-27 | Novartis Pharmaceuticals | Results Novartis announces Phase III study of Arzerra® met primary endpoint of improved progression-free survival in patients with relapsed CLL novartis.com ↗
Positive top-line results seen with Arzerra plus fludarabine and cyclophosphamide in chronic lymphocytic leukemia (CLL) patients when initial treatment stopped working |
| 2013-11-21 | PNP Therapeutics, Inc. | Results PNP Therapeutics Cancer-fighting Technology Progressing Well in Phase I Clinical Trial pnptherapeutics.com ↗
The therapy was well-tolerated in the first nine patients, and doctors have detected efficacy. |
| 2010-04-22 | Geron Corporation | Results Geron Gives Five Presentations on Telomerase Inhibitor Imetelstat at the AACR Annual Meeting geron.com ↗
Telomerase Inhibition Affects Fludarabine Sensitivity in Quiescent Primary Chronic Lymphocytic Leukemia Lymphocytes |
| 2010-02-18 | Biogen | Regulatory FDA Approves Rituxan Plus Chemotherapy for the Most Common Type of Adult Leukemia biogen.com ↗
Genentech, Inc., a wholly owned member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), and Biogen Idec (Nasdaq: BIIB) announced today the U.S. Food and Drug Administration (FDA) approved Rituxan ® (rituximab) in combination with fludarabine and cyclophosphamide (FC) for people with previously untreated and previously treated CD20-positive chronic lymphocytic leukemia (CLL). |
| 2008-12-06 | Biogen | Results Rituxan in Combination with Chemotherapy Improves Progression-Free Survival in Difficult-to-Treat Form of Blood Cancer biogen.com ↗
Immunotherapy with Fludarabine, Cyclophosphamide and Rituximab (FCR) Versus Fludarabine and Cyclophosphamide (FC) Improves Response Rates and Progression-Free Survival (PFS) of Previously Untreated Patients with Advanced Chronic Lymphocytic Leukemia (CLL) (Abstract #325) |
| 2008-10-07 | Biogen | Results Phase III Study Showed Rituxan in Combination with Chemotherapy Improved Progression-Free Survival in Patients with Relapsed Chronic Lymphocytic Leukemia biogen.com ↗ |
| 2004-04-29 | Teva Branded Pharmaceutical Products R&D, Inc. | Regulatory Teva Announces Approval Of Fludarabine Phosphate Injection tevapharm.com ↗
Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) announced today that the U.S. Food and Drug Administration has granted approval for an ANDA for Fludarabine Phosphate Injection, 25 mg/ml, which was submitted by the Company's subsidiary Sicor Inc. |
All press releases naming this drug 27 releases
Evidence & citations 28 cited values
Every value below carries the sentence it was read from. 1,998 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Fludarabine | “RIC preconditioning regimen consisted of cytarabine (2 g/m2/day, days -10 to -9), busulfan (3.2 mg/kg/day on days -8 to -6), cyclophosphamide (1.0 g/m2/day, days -5 to -4),...” NCT03412266 ↗1686“In the control arm, patients received other physician-directed regimen including fludarabine, cytarabine with/without granulocyte stimulating factor(FLA±G) regimen,cytarabine...” NCT02937662 ↗ “50% of the patients will receive Fludarabine + cyclophosphamide (F-araA 120 mg/m2 total dose for 3 days (d-3,-2,-1) over 1 h infusion and cyclophosphamide 25 mg/kg/d (d-5 to...” NCT03295058 ↗ “* FLAG ± Ida regimen: G-CSF injection 300 mcg/m2 QD SC for 5 consecutive days (Days 1-5); fludarabine injection 30 mg/m2 QD IV for 5 consecutive days (Days 2-6); cytarabine...” NCT06387069 ↗ “Adoptive Cell Therapy consisting of the lymphocyte depleting preparative regimen consisting of fludarabine and cyclophosphamide, followed by infusion of between 1x10\^9 to...” NCT01118091 ↗ “Lymphodepletion chemotherapy consisting of Fludarabine 30 mg/m2 IV once daily x 4 doses; and Cyclophosphamide 500mg/m2 IV once daily x 2 doses (starting with the first dose of...” NCT05010564 ↗ “Study participants will receive a non-TBI based preparative regimen consisting of Cyclophosphamide, fludarabine, thiotepa, melphalan, and muromonab-CD3 (OKT3) followed by an...” NCT00145626 ↗ “SENTI-202 is administered in either a 3 dose regimen (Schedule 1: Days 0, 7, 14) or a 5 dose regimen (Schedule 2: Days 0, 3, 7, 10, 14) of a 28-day treatment cycle following a...” NCT06325748 ↗ “Twenty-two children with a median age of 2.8 years, many with severe comorbidities and prior viral infections, were enrolled in a novel RIC protocol consisting of hydroxyurea,...” PMID 24296492 ↗ Dec 2013 “The regimen consists of treatment with cyclophosphamide and fludarabine,followed by infusion of up to 3x1011 lymphocytes (minimum of 1x109) expanded in vitro from subjects own...” NCT03526185 ↗ “Patients receive a preparative lymphodepleting chemotherapy of intravenous cyclophosphamide and fludarabine from day -5 until day -3 (or Bendamustine on day -3 and day -2),...” NCT07166549 ↗ |
| Known as | 2-F-ara-AMP | “2-F-ara-AMP” NCT01168219 ↗1“2-F-ara-AMP” NCT00801489 ↗ |
| Known as | 9H-Purin-6-amine, 2-fluoro-9-(5-O-phosphono-.beta.-D-arabinofuranosyl)- | “9H-Purin-6-amine, 2-fluoro-9-(5-O-phosphono-.beta.-D-arabinofuranosyl)-” NCT02220985 ↗ |
| Known as | Beneflur | “Beneflur” NCT02727803 ↗ |
| Known as | F-araA | “50% of the patients will receive Fludarabine + cyclophosphamide (F-araA 120 mg/m2 total dose for 3 days (d-3,-2,-1) over 1 h infusion and cyclophosphamide 25 mg/kg/d (d-5 to...” NCT03295058 ↗ |
| Known as | FAMP | “This is a phase I study of 7-hydroxystaurosporine (UCN-01) and fludararbine monophosphate (FAMP) in relapsed lymphoma.” PMID 21745173 ↗ Jul 2011 |
| Known as | FLU | “After the promising results of our preliminary study, we conducted a phase II prospective multicenter clinical trial using a fludarabine (Flu), cyclophosphamide (Cy), and...” PMID 20685256 ↗ May 201031“All patients received cyclophosphamide (CY), single fraction total body irradiation (TBI), and antithymocyte globulin (ATG) with or without fludarabine (FLU), followed by...” PMID 25824692 ↗ Mar 2015 “We hypothesized that lymphodepletion, achieved with cyclophosphamide (Cy) and fludarabine (Flu), would promote in vivo expansion of the infused lymphocytes enhancing their...” PMID 17579184 ↗ Jun 2007 “For participants identified as having stable or progressive disease (National Cancer Institute Criteria), Fludarabine (Flu) therapy will be added to VPA on a 28 day cycle.” NCT00524667 ↗ “The preparative regimen included high-dose (131)I-MIBG on day -20, followed by fludarabine (Flu), thiotepa, and melphalan (Mel) from day -8 to -1.” PMID 19660720 ↗ Jul 2009 “Patients in both groups received i.v. fludarabine (Flu) 30 mg/m(2)/day and i.v. busulfan (Bu) 0.8 mg/kg/day on days -5 to -2 as conditioning” PMID 19539216 ↗ Jul 2009 “Participants with Severe Aplastic Anemia will receive Fludarabine at 125 mg/m squared plus Cyclophosphamide at 60 mg/kg (Flu/Cy).” NCT01187017 ↗ “fludarabine (Flu) and cyclophosphamide (Cy), at different dosages, as the standard lymphodepletion regimen.” NCT07593482 ↗ “Fludarabine (Flu) is one part of the conditioning regimen. 150 mg/m2 (30 mg/m2 per day on days -6 to -2)” NCT06680661 ↗ “cyclophosphamide (Cy, 1000 mg/m2/day, day -6 to -5), and fludarabine (Flu, 25 mg/m2/day, day -6 to -2)” NCT04221971 ↗ “Fludarabine (FLU) is administered as a lymphodepletion regimen prior to NK042 infusion.” NCT06773091 ↗ |
| Known as | Flud | “Fludarabine (Flud)” NCT07025824 ↗ |
| Known as | Fludara | “Subcutaneous MabCampath® (Alemtuzumab) and Oral Fludara® (Fludarabinephosphate) for the Treatment of Refractory or Relapsed Chronic Lymphocytic Leukemia” NCT00565981 ↗20“Alemtuzumab (Campath) 30mg subcutaneous (SC) plus Fludarabine (Fludara) 25mg/m² intravenous (IV), Days 1-5 every 28 days” NCT00206726 ↗ “Fludarabine (Fludara®, Schering AG, Berlin, Germany) 30 ㎎/㎡ i.v. over 30 minutes in D5W 100 ㎖ on days -6 to -2” NCT00774280 ↗ “Drug: Fludarabine 30 mg/m2 i.v. for 3 consecutive days (Day -5\~Day -3) Other Name: FLUDARA” NCT05211557 ↗ “busulfan (Bu), cyclophosphamide (Cy) and fludarabine (FLUDARA)” NCT00208923 ↗ “Other Names: Fludarabine Phosphate Fludara” NCT02809092 ↗ “Fludarabine (Fludara, Berlex Laboratories)” NCT01861106 ↗ “Fludarabine(Fludara, Berlex Laboratories)” NCT01176006 ↗ “Fludarabine, Fludara®, Bayer Shering” NCT00937300 ↗ “Fludarabine Phosphate (Fludara)” NCT00185445 ↗ “Fludarabine Phosphate (Fludara)” NCT00220311 ↗ |
| Known as | Fludarabine (FLU) | “Fludarabine (FLU)” NCT01565616 ↗ |
| Known as | Fludarabine (Fludara) | “Fludarabine (Fludara®)” NCT07486089 ↗1“Fludarabine (Fludara)” NCT01877837 ↗ |
| Known as | Fludarabine (Fludara, Berlex Laboratories, Richmond, CA) | “Fludarabine (Fludara®, Berlex Laboratories, Richmond, CA)” NCT00815568 ↗ |
| Known as | fludarabine monophosphate | “Ad/PNP will be injected three times into the tumor over 2 days followed by three daily intravenous infusions of F-araAMP (fludarabine monophosphate).” NCT01310179 ↗11“Drug: Fludarabine monophosphate 30 mg/m2 by vein on Days -6, -5, -4, -3, and -2.” NCT02809092 ↗ |
| Known as | fludarabine phosphate | “Patients receive fludarabine phosphate IV over 30 minutes and alemtuzumab IV over 30 minutes on days -7 through -3 and melphalan IV over 30 minutes on day -2.” NCT01256398 ↗313“Reduced-intensity preparative regimen: Patients receive fludarabine phosphate IV on days -6 to -2 and melphalan IV on day -1.” NCT00800150 ↗ “Fludarabine Phosphate (Days -4 to -2): IV administration of fludarabine phosphate over 30 minutes on days -4 to -2.” NCT07066995 ↗ “Patients also receive fludarabine phosphate IV over 30 minutes on days 1-5 of weeks 1, 5, 9, 13, 17, and 21.” NCT00513747 ↗ “a drug called fludarabine phosphate, which is approved by the FDA for certain types of blood-cell cancers” NCT01310179 ↗ “Patients receive fludarabine phosphate(300 mg/m\^2) and cyclophosphamide (30 mg/m\^2) IV on days -5 to -3” NCT03672851 ↗ “patients receive fludarabine phosphate IV over 30 minutes” NCT00389506 ↗ “Other Names: Fludarabine Phosphate Fludara” NCT02809092 ↗ “Drug: fludarabine phosphate” NCT00004862 ↗ “Drug: Fludarabine Phosphate” NCT05761171 ↗ “Drug: fludarabine phosphate” NCT00043979 ↗ |
| Known as | Fludarabine phosphate (2-F-ara-AMP) | “Fludarabine phosphate (2-F-ara-AMP)” NCT01707004 ↗ |
| Known as | fludarabine phosphate (Fludara) | “fludarabine phosphate (Fludara)” NCT02784561 ↗ |
| Known as | Fludarabine Phosphate for Injection | “Fludarabine Phosphate for Injection” NCT06481735 ↗2“Fludarabine Phosphate for Injection” NCT05554939 ↗ “Fludarabine Phosphate for Injection” NCT06838832 ↗ |
| Known as | Fludarabine, Fludara, Bayer Shering | “Fludarabine, Fludara®, Bayer Shering” NCT00937300 ↗1“Fludarabine, Fludara®, Bayer Shering” NCT00937625 ↗ |
| Known as | fludarabine: Fludara(R) | “fludarabine: Fludara(R)” NCT00640796 ↗ |
| Known as | Fludarabinephosphat | “Drug: Fludarabinephosphat 5 doses (25 mg/m2, max. 50 mg) prior to infusion” NCT06204991 ↗ |
| Known as | fludararbine monophosphate | “This is a phase I study of 7-hydroxystaurosporine (UCN-01) and fludararbine monophosphate (FAMP) in relapsed lymphoma.” PMID 21745173 ↗ Jul 2011 |
| Known as | fludararbine phosphate | “Phase I trial of 7-hydroxystaurosporine and fludararbine phosphate: in vivo evidence of 7-hydroxystaurosporine induced apoptosis in chronic lymphocytic leukemia.” PMID 21745173 ↗ Jul 2011 |
| Known as | Fludara | “Conditioning therapy will start on day -6 in patients who are randomized to receive Cy+fludarabine (Fludara®, Berlex Laboratories, Richmond, CA)+ATG.” NCT00774527 ↗ |
| Known as | Interventions:◦Drug: Fludarabine | “Interventions:◦Drug: Fludarabine” NCT01983761 ↗ |
| Known as | SH T 586 | “Fludarabine Phosphate Tablet (SH T 586)” NCT00311129 ↗1“SH T 586” NCT03670966 ↗ |
| Action | Inhibit | “nucleoside analogs inhibits DNA repair” NCT00001676 ↗ |
| Modality | Small molecule | “nucleoside analogs chlorodeoxyadenosine and fludarabine” NCT00001676 ↗ |
| Route | Intravenous | “intravenous fludarabine” NCT00001422 ↗ |