This notification is to inform you that the Compassionate Use Program for EXKIVITY is now open for enrollment in the U.S. The withdrawal of EXKIVITY will occur no later than March 2024, with the specific date still to be determined by the US Food and Drug Administration (FDA) based on review of ongoing operational activities related to the withdrawal.
- Patients prescribed EXKIVITY through March 2024 will be eligible for this Compassionate Use Program. The Compassionate Use Program will provide these patients with product free of charge for as long as they are deriving benefit from the drug, as assessed by their healthcare provider.
- Shipments from the Compassionate Use Program will not begin until withdrawal. Takeda will be coordinating this once enrollment submission has been complete.
- For transparency and in support of addressing questions, a similar letter will be shared with patients currently prescribed EXKIVITY for whom we have contact information on file for. Patients will be directed to speak with their healthcare provider about the Compassionate Use Program and the enrollment process.
As a reminder and until withdrawal, EXKIVITY continues to be available to prescribe for new and existing patients through normal channels for patients with epidermal growth factor receptor (EGFR) Exon20 insertion mutation-positive locally advanced or metastatic non-small cell lung cancer (mNSCLC) whose disease has progressed on or after platinum-based chemotherapy. For the U.S. Prescribing Information, including the Boxed Warning, please visit www.exkivity-update.com/prescribing-information.
EXKIVITY will no longer be available for new patients after withdrawal in March 2024.
This is a courtesy communication and there is no action needed on your end. Updates will also be posted on www.exkivity-update.com.
For additional questions, please contact Takeda at 844-662-8532 between the hours of 8:00am and 6:00pm EST or email@example.com.