12/08/2023

Takeda Update on EXKIVITY® (mobocertinib) Withdrawal and Compassionate Use Program

This notification is being provided to update you on the official withdrawal of EXKIVITY (mobocertinib), which 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. Until withdrawal, EXKIVITY continues to be available to prescribe 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.

As we mentioned in our first communication, patients receiving EXKIVITY will be able to maintain access following withdrawal from the market through a compassionate use program that is being established. After withdrawal, the compassionate use program will provide prescribed patients access to EXKIVITY free of charge for as long as they are benefiting from the medication, as assessed by their HCP. However, EXKIVITY will no longer be available for new patients following withdrawal from the market, which will occur no later than March 2024.

A few important notes about the compassionate use program:

• Timing: Takeda will begin enrolling patients starting January 15^th to ensure a seamless transition with the goal of minimizing disruption.
• The compassionate use program will begin shipping product at the time of withdrawal in March 2024.
• EXKIVITY will continue to be available through standard distribution channels until March 2024.
• Eligibility: Only patients prescribed EXKIVITY prior to withdrawal will be eligible for this compassionate use program.
• How to Enroll: HCPs will receive a letter early in January on how to enroll patient(s).

Takeda will provide additional updates to keep you informed where appropriate. Updates will also be posted on www.exkivity-update.com.

For additional questions, please contact Takeda at 844-662-8532 between the hours of 8:00 am and 6:00 pm EST, or globaloncologymedinfo@takeda.com.