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Important Information About EXKIVITY® (mobocertinib)

Following discussions with the U.S. Food and Drug Administration (FDA), EXKIVITY (mobocertinib) will be officially withdrawn from the market in the United States no later than March 2024.

EXKIVITY remains available to prescribe until the official withdrawal to treat adults with non-small cell lung cancer that has spread to other parts of the body and has epidermal growth factor receptor gene, and whose disease has worsened while on or after chemotherapy that contains platinum. For Patient Information including boxed warning please see the link above.

Patients receiving EXKIVITY will be able to maintain access following withdrawal from the market through a Compassionate Use Program. The Compassionate Use Program is now open for enrollment. Takeda has provided healthcare providers with guidance on how to enroll existing patients prescribed EXKIVITY into the Compassionate Use Program. EXKIVITY will no longer be available through commercial pharmacies after withdrawal in March 2024.

We encourage you to consult with your healthcare provider to learn more about the Compassionate Use Program and your ongoing access with EXKIVITY. Takeda is committed to supporting healthcare providers transition eligible patients into the Compassionate Use Program.

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

To report SUSPECTED ADVERSE REACTIONS, contact Takeda Pharmaceuticals
America, Inc. at 1-844-217-6468 or the FDA at 1-800-FDA-1088 or