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  1. pharmadog
  2. ›drugs
  3. ›FULVESTRANT
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FULVESTRANT

Marketedupdated 5mo ago
by Eagle Pharmaceuticals Inc
Approved
community read0 votes

🐶 often sniffed alongside

top 2
  • tagApproval8 co-mentions · 4 sources
  • tagSmall Molecule1 co-mentions · 1 sources

all catalysts(4)

approval · 4
Aug 19, 2019
approval
7y ago
FULVESTRANT — FDA approval
FULVESTRANT
→
Apr 6, 2021
approval
5y ago
FULVESTRANT — FDA approval
FULVESTRANT
→
Nov 12, 2021
approval
5y ago
FULVESTRANT — FDA approval
FULVESTRANT
→
Nov 21, 2025
approval
10mo ago
FULVESTRANT — FDA approval
FULVESTRANT
→

Trials studying FULVESTRANT

  • phase2Study of AVZO-021 in Patients With Advanced Solid Tumorsrecruitingn=430
  • phase3A Study of Tersolisib (LY4064809/STX-478) With Other Anti-Cancer Treatments in Participants With Advanced Breast Cancer With a Genetic Change (PIK3CA)recruitingn=800
  • phase2Study Assessing the Efficacy and Safety of Treatment With Alpelisib Plus Fulvestrant Versus Placebo Plus Fulvestrant in Chinese Men and Postmenopausal Women With Advanced Breast Canceractive not recruitingn=69
  • phase2A Phase 1/2 Trial of TER-2013 in Patients With Solid Tumors Harboring AKT/PI3K/PTEN Pathway Alterationsrecruitingn=205
  • phase4Roll-over Study to Allow Continued Access to Ribociclibactive not recruitingn=134
  • phase2Fulvestrant Plus Abemaciclib in Women With Advanced Low Grade Serous Carcinomaactive not recruitingn=18
  • phase3Comparison of Fulvestrant (FASLODEX™) 250 mg and 500 mg in Postmenopausal Women With Oestrogen Receptor Positive Advanced Breast Cancer Progressing or Relapsing After Previous Endocrine Therapy.active not recruitingn=736
  • phase3A Study to Evaluate Efficacy and Safety of Giredestrant Compared With Fulvestrant (Plus a CDK4/6 Inhibitor), in Participants With ER-Positive, HER2-Negative Advanced Breast Cancer Resistant to Adjuvant Endocrine Therapy (pionERA Breast Cancer)active not recruitingn=1,050

Patent cliff

source: FDA Orange Book
first barrier falls
Feb 14, 2034
~7.4 years out

Earliest of all listed patents + FDA exclusivities. Generic / biosimilar entry typically only becomes possible AFTER both patent and exclusivity barriers expire.

patents (3)

  • May 17, 2034formulationUS 9271990
  • Feb 14, 2034formulationUS 10188663
  • Feb 14, 2034formulationUS 9833459

News(10)

  • AstraZeneca’s newly approved pill fails frontline breast cancer study
    Etcamah is the second oral “SERD” to recently fall short in first-line breast cancer, following a similar setback from Roche earlier this year.
    biopharma_dive · 16d ago
  • Celcuity gains FDA approval for closely watched breast cancer drug
    Still, shares fell by nearly 20% after the company revealed a delay in the coming launch of Revtorpyk. Details in the drug’s prescribing information surprised some analysts, too.
    biopharma_dive · 2mo ago
  • Celcuity wins approval for breast cancer drug Revtorpyk
    A small public biotech won approval for a breast cancer drug that was designed to improve on similar treatments from Novartis and Roche. The FDA on Tuesday cleared Celcuity's Revtorpyk in combinati…
    endpoints · 2mo ago
  • Evolving Oral SERD Research Seeks to Redefine Treatment Strategies in Hormone Receptor+ Breast Cancer
    Breast cancer experts discuss the nuances of ESR1 mutations and oral SERD use in hormone receptor–positive breast cancer.
    onclive · 4mo ago
  • Dr McCann on the FDA Approval of Vepdegestrant for ESR1-Mutated, ER+ Advanced Breast Cancer
    Kelly Elizabeth McCann, MD, PhD, notes the role of vepdegestrant in the ESR1-mutated, ER-positive, HER2-negative advanced breast cancer treatment paradigm.
    onclive · 4mo ago
  • Honesty and Humor Provide Hope in Breast Cancer Survivorship: With Sara Nunnery, MD, MSCI; and Annie Bond
    Dr Nunnery and Annie Bond discuss breast cancer survivorship and patient advocacy.
    onclive · 4mo ago
  • Dr Silbermann on Clinical Trial Design Considerations in Multiple Myeloma
    Rebecca Silbermann, MD, MMS, outlines key trial design considerations in multiple myeloma, including supportive care measures and end point selection.
    onclive · 4mo ago
  • MimiVax and Roswell Park Open Phase 2 Trial of SurVaxM for Patients with Metastatic Neuroendocrine Tumors
    Roswell Park Comprehensive Cancer Center launched a phase 2 trial evaluating SurVaxM plus temozolomide in progressing neuroendocrine tumors.
    onclive · 4mo ago
  • Dr Randall on the Rationale for Investigating CSF-1R Inhibition in TGCT
    R. Lor Randall, MD, FACS discusses safety and efficacy data from the MANEUVER trial, which evaluated pimicotinib in TGCT.
    onclive · 4mo ago
  • RAPNO Criteria and MRI Assessment in PLGG: Recommendations vs. Real-World Practice
    Learn how clinicians weigh symptoms, MRI changes and family goals to decide when a child’s tumor needs treatment—beyond simple size cutoffs.
    onclive · 4mo ago
view all news mentions →
brand
FULVESTRANT
generic
FULVESTRANT
indication
Hormone Sensitive Breast Cancer
phase
marketed
Data sources
openFDA · ClinicalTrials.gov
last refreshed 4h ago
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