Sponsor Overview
Explore verified public information about Astellas Pharma Global Development, Inc.'s expanded access programs, compassionate use policies, and patient eligibility pathways. This report aggregates official statements, independent research, and regulatory data to help patients, providers, and sponsors collaborate efficiently.
Unique references curated across 4 content categories.
ClinicalTrials.gov data sources power this status.
Dataset refreshed continuously through Right2Hope ETL pipelines.
Expanded Access Intelligence
Official Statements
Score contribution: 100 — 8 supporting sources.
“As described in our Position on Early Access and Post-Trial Access to Investigational Therapy, Astellas believes the safest and most effective way of providing access to our investigational therapies is through enrollment in our ongoing clinical trials. Astellas also recognizes the importance of utilizing the applicable regulatory and legal pathways for providing access to our investigational therapies when patients with serious and life-threatening diseases have exhausted all available treatment options and are not eligible for clinical trials.”
“Astellas defines “early access” as the provision of an Astellas investigational therapy to patients outside of the clinical trial setting, upon receipt of an unsolicited request by a prescribing healthcare professional.1 Where permitted by local regulations, Astellas will consider unsolicited early access requests from physicians for patients with no viable therapeutic alternatives. Requests are considered on a case by case basis, although provision of early access cannot be guaranteed when requested.”
“Astellas commits to establishing early and post-trial access programs for investigational therapies and patients that meet the following criteria: The investigational therapy is actively being developed to treat a serious, life-threatening disease Safety and efficacy data that supports continued development with the dose selected and the intent to pursue marketing approval.”
“Astellas commits to establishing expanded access plans for investigational medicines and patients that satisfy the following conditions: 1. The disease or condition being studied is serious or life-threatening 2. The patient has exhausted all available treatment options 3. The provision of expanded access does not delay, interfere or compromise the completion of the clinical trial process and registration of the medicine 4. The medicine is in active clinical development and not available on the commercial market 5. Patient is ineligible for clinical trials 6. There is sufficiently robust preliminary safety and efficacy data including dosing information 7. The potential benefit to the patient outweighs the risks 8. The patient’s physician, the institutional review board/ethics committee and regulatory authority have authorized the provision of the investigational drug”
“Outside of the clinical trial setting, we run early access*1 and post-trial access programs*2 to support patients with serious and life-threatening diseases seeking access to our investigational therapies.”
“Astellas has set forth its approach to supplying investigational medicines to patients for purposes other than clinical trials in its Position on Early Access and Post-Trial Access to Investigational Therapy.”
Active EAPs on ClinicalTrials.gov
Score contribution: 60 — 1 supporting sources.
Conditions: Locally Advanced Unresectable Gastroesophageal Junction (GEJ) Adenocarcinoma Cancer, Locally Advanced Unresectable Gastric Adenocarcinoma Cancer, Metastatic Gastric Adenocarcinoma Cancer, Metastatic Gastroesophageal Junction (GEJ) Adenocarcinoma
Past EAPs on ClinicalTrials.gov
Score contribution: 40 — 4 supporting sources.
Conditions: Metastatic Castration-Resistant Prostate Cancer
Conditions: Locally Advanced or Metastatic Urothelial Carcinoma (UC)
Conditions: Acute Myeloid Leukemia (AML), FMS-like Tyrosine Kinase-3 (FLT3) Mutations
Conditions: Acute Myeloid Leukemia (AML), FMS-like Tyrosine Kinase-3 (FLT3) Mutations
Reagan-Udall Foundation Insights
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