The purpose of this program is to provide elexacaftor/tezacaftor/ivacaftor (ELX/TEZ/IVA) to CF patients in critical need who are 6 to 11 years of age with at least one F508del mutation in response to unsolicited physician requests.

Key Inclusion Criteria:

• Patients with confirmed diagnosis of CF who have an F/any genotype
• Prior treatment for at least 6 months with an approved alternative CFTR modulator (if the patient is eligible for such treatment)
• Patients with percent predicted forced expiratory volume in 1 second (ppFEV1) <40 for a minimum of 60 consecutive days before the date of completion of the request form

Key Exclusion Criteria:

• Patients with severe hepatic impairment

Other protocol-defined inclusion/exclusion criteria may apply