Phone
N/A
Acknowledgement
Immediately
Advanced Accelerator Applications
Novartis
Novartis Pharmaceuticals
Novartis Vaccines
EA Policies for Single Patient

Novartis considers granting managed access to investigational or pre-approval products via single patient access provided the Managed Access criteria are fulfilled.

EA Policies for Disease / Category

Product

Indication

Capmatinib

MET dysregulated Non-Small Cell Lung Cancer (NSCLC)

Ceritinib

Non-small cell lung cancer: ALK positive tumors, previously pre-treated with ALK inhibitors or naive

Clofazimine

Mycobacterial infection

Iptacopan

C3 Glomerulopathy (C3G)

Tisagenlecleucel

Acute lymphoblastic leukaemia; Diffuse large B-cell lymphoma refractory

COVID-19 Information

COVID-19 Information Center https://www.novartis.com/coronavirus

Ruxolitinib Managed Access Program (MAP) for Patients Diagnosed With Severe/Very Severe COVID-19 Illness

Novartis announces plan to initiate clinical study of Jakavi® in severe COVID-19 patients and establish international compassionate use program - Novartis to establish compassionate use program for COVID-19 patient access and undertake steps to ensure uninterrupted supply of Jakavi for currently licensed indications. (Jakavi/Jakafi is marketed by Novartis outside the United States. In the United States, the product is marketed by Incyte, Inc.)

The multiple sclerosis drug Gilenya and fever drug Ilaris are also being studied for their effect on complications related to COVID-19.

Novartis donates 20,000 doses of hydroxychloroquine for COVID-19 PEP clinical trial. For more information:

https://www.us.sandoz.com/news/media-releases/novartis-donates-20000-doses-hydroxychloroquine-covid-19-pep-clinical-trial

https://newsroom.uw.edu/news/does-antimalarial-drug-prevent-covid-19-study-seeks-answers

https://depts.washington.edu/covid19pep/

Novartis donation: Consignment of 30 million hydroxychloroquine tablets ships to US Department of Health and Human Services

https://www.sandoz.com/news/media-releases/novartis-donation-consignment-30-million-hydroxychloroquine-tablets-ships-us

Stage
Phase 3
Expanded Access
Company Type
Late Onset Intervention
Neoplasms, Breast

This study will provide pre-approval drug access to lapatinib, in combination withcapecitabine, to patients whose breast cancer had progressed on other therapies

Acromegaly

The present study is planned as an expanded treatment protocol to provide acromegalicpatients for whom medical therapy is appropriate access to pasireotide LAR whileregulatory approval for pasireotide is sought.

Neuroendocrine Tumors

Advanced Accelerator Applications is currently pursuing marketing approval for177Lu-DOTA0-Tyr3-Octreotate (Lutathera). This expanded access therapeutic protocol aimsto allow patients suffering from inoperable, somatostatin receptor positive,neuroendocrine tumors, progressive under somatostatin analogue therapy to access theinvestigational product, 177Lu-DOTA0-Tyr3-Octreotate (Lutathera), prior to its commercialavailability.

Acute Lymphoblastic Leukemia (ALL)
Diffuse Large B-cell Lymphoma (DLBCL)

Managed Access Program (MAP) to provide access to CTL019, for acute lymphoblasticleukemia (ALL) or diffuse large b-cell lymphoma (DLBCL) patients with out ofspecification leukapheresis product and/or manufactured tisagenlecleucel out ofspecification for commercial release.