Kite, A Gilead Company - Expanded Access Programs

Expanded Access Intelligence

Official Statements

Score contribution: 100 — 1 supporting sources.

Score 1001 references

Featured Reference

Managed Access at Gilead SciencesOpens in new window

“When it isn't possible for a patient to enroll in a clinical trial, we consider requests for access to the medical products for individual patient use, or through an expanded access protocol when appropriate.”

EAP Related Articles from Sponsor

Score contribution: 80 — 7 supporting sources.

Score 807 references

Featured Reference

Gilead Sciences Announces Start of Expanded Access Program for PREVEONOpens in new window

Gilead Sciences, Inc. today announced an expanded access program for PREVEON; (adefovir dipivoxil) for people with advanced HIV infection in the United States who have limited treatment options.

Gilead Announces Start of Early Access Program for Investigational Anti HIV Agent Tenofovir DF in United States and FranceSource

Gilead Sciences, Inc. (Nasdaq: GILD) today announced the initiation of a limited expanded access program to provide tenofovir disoproxil fumarate (tenofovir DF) to people with advanced human immunodeficiency virus (HIV) infection in the United States and multiple countries in the European Union.

Gilead Announces Expanded Access Program for Aztreonam Lysine for Inhalation for Patients with Cystic FibrosisSource

Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the company will initiate an expanded access program beginning August 1, 2007 to provide its investigational therapy, aztreonam lysine for inhalation, to patients with cystic fibrosis (CF) and Pseudomonas aeruginosa (P. aeruginosa) infection who have limited treatment options and are at risk for disease progression.

Gilead Sciences Medication Access ProgramsSource

Managed access provides eligible patients with serious or life-threatening conditions with access to medicinal products for treatment outside of clinical trials when no comparable or satisfactory alternative therapy options are available. Managed access encompasses compassionate use, expanded access, early access and individual patient use.

Gilead Statement on Discontinuation of Phase 3 ENHANCE-3 Study ...Source

FDA Places Full Clinical Hold on All Magrolimab AML and MDS Studies, Including Expanded Access Programs

Gilead Announces Partial Clinical Hold for Magrolimab Studies in AMLSource

Effective immediately, screening and enrollment of new study participants under the U.S. investigational new drug application (IND 147229) and U.S. Expanded Access Program will be paused.

Active EAPs on ClinicalTrials.gov

Score contribution: 60 — 2 supporting sources.

Score 602 references

Featured Reference

Expanded Access Study for the Treatment of Patients With Commercially Out-of-Specification Axicabtagene CiloleucelOpens in new window

Conditions: Large B-cell Lymphoma, Follicular Lymphoma

Expanded Access Study for the Treatment of Patients With Commercially Out-of-Specification Brexucabtagene AutoleucelSource

Conditions: Mantle Cell Lymphoma, Acute Lymphoblastic Leukemia

Past EAPs on ClinicalTrials.gov

Score contribution: 40 — 2 supporting sources.

Score 402 references

Featured Reference

Axicabtagene Ciloleucel Expanded Access StudyOpens in new window

Conditions: Relapsed/Refractory Diffuse Large B Cell Lymphoma, Relapsed/Refractory Primary Mediastinal B Cell Lymphoma, Relapsed/Refractory Transformed Follicular Lymphoma, Relapsed/Refractory High-Grade B-Cell Lymphoma

Study of Brexucabtagene Autoleucel (KTE-X19) for the Treatment of Individuals With Relapsed/Refractory B-Cell MalignanciesSource

Conditions: Relapse/Refractory Mantle Cell Lymphoma

Partner with Right2Hope

Right2Hope helps sponsors translate regulatory programs into actionable patient access pathways. Connect with our team to publish new programs, streamline intake workflows, or align with providers seeking compassionate use options.

Talk to Our Team Explore Programs