Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

“CompAC is a novel approach that Johnson & Johnson employs globally to provide an equitable, fair and ethical evaluation of compassionate use requests for specific investigational medicines for patients with serious or life-threatening diseases.”

“What happens now is that a patient’s physician submits a request for a drug made by our company by either calling a number or visiting our website. That request then gets funneled to the medical team working on the drug to make sure there are no contraindications, or reasons why it would be dangerous for that particular patient to try it. The request also goes to the CompAC, which does a complete review of the patient’s application and medical condition. After an extremely thorough analysis, keeping our ethical principles front and center, the CompAC makes a recommendation as to whether the request should be approved or denied. Johnson & Johnson gets the final say, but so far, we have followed 100% of the committee’s recommendations, which has led to more than 60 patients receiving access to one of our cancer treatments that has since been granted FDA approval.”

Up to 200,000 Johnson & Johnson Ebola vaccine regimens will be made available as part of a WHO early access clinical program now underway in Sierra Leone.

Janssen has established an expanded access program (EAP) [NCT04599712] for patients in the U.S. who may be eligible to obtain access to amivantamab during FDA review of the Biologics License Application. For information about Janssen’s pre-approval access program, visit https://www.janssen.com/compassionate-use-pre-approval-access.

The amivantamab EAP is for U.S. patients 18 years of age or older who have histologically or cytologically confirmed unresectable or metastatic NSCLC with an EGFR exon 20 insertion mutation; who are not amenable to curative therapy; whose disease has progressed during or after current standard of care platinum-based chemotherapy; and who may benefit from treatment with amivantamab prior to its potential FDA approval. The EAP has specific inclusion and exclusion criteria for patients to be considered for enrollment in the program, and patients must not be eligible for another amivantamab study. Interested patients should contact their physician to discuss whether they may be a candidate for amivantamab through the EAP. Additional information about the expanded access protocol can be found on clinicaltrials.gov (NCT04599712) and at https://www.janssen.com/compassionate-use-pre-approval-access.

The Company has also established an expanded access program (EAP) for patients in the U.S. who may be eligible to obtain access to amivantamab during review of the BLA. For information about Janssen’s pre-approval access program, visit https://www.janssen.com/compassionate-use-pre-approval-access.

Compassionate Use Advisory Committee (CompAC) Provides guidance to Janssen on compassionate use requests for investigational medicines, enabling an equitable, fair and ethical evaluation of requests.