Locally Advanced or Metastatic Cancer Resistant or Refractory to Available Treatment Options and Candidate for Therapy With a CDK Inhibitor Clinical Trial
Managed Access Program (MAP) Cohort Treatment Plan CLEE011A2408 to Provide Access to Ribociclib (LEE011, Kisqali®), for Locally Advanced or Metastatic Cancer Resistant or Refractory to Available Treatment Options and Candidate for Therapy With a CDK Inhibitor (Including Tumors With D-cyclin-CDK4/6-INK4a-Rb Pathway Abnormalities)
The purpose of this Managed Access Program (MAP) Cohort Treatment Plan is to provide guidance to the Physician for the treatment and monitoring of patients in the Cohort MAP. The Physician should follow the suggested treatment guidelines. Furthermore, the Physician must comply with the MAP Agreement Letter and applicable local laws and regulations.
Prior to inclusion of a patient in the Cohort, the requesting Physician must submit a request for access to the product in GEMS (Grants, External Requests and Managed Access System) accessible through https://www.novartis.com/our-focus/healthcare-professionals/managed-access-programs providing the rationale for the request and relevant medical history of the patient. The request is then assessed against the MAP and Cohort inclusion/exclusion criteria by the medical team experienced with the product and indication. Upon the required approvals, the patient is included in the Cohort. ;