Dear Valued Healthcare Partner,

We are informing you that Takeda, following alignment with the U.S Food and Drug Administration, has announced that EXKIVITY (mobocertinib) is no longer commercially available in the U.S. market.

EXKIVITY was previously indicated for adult patients with epidermal growth factor receptor (EGFR) Exon20 insertion mutation-positive (insertion+) locally advanced or metastatic non-small cell lung cancer (mNSCLC) whose disease had progressed on or after platinum-based chemotherapy.

As of April 8, 2024, Takeda will no longer provide EXKIVITY commercially. As previously communicated, Takeda launched a Compassionate Use Program (“Program”) in January to ensure patients on or prescribed EXKIVITY before April 1, 2024 could have access to the drug. Only patients who were prescribed EXKIVITY prior to April 1, 2024 will be eligible for the Program. Healthcare providers have been notified and provided resources to complete Program submission per patient eligibility.

Takeda is committed to our patients and ensuring patients on therapy can continue access. For questions regarding enrollment in the Compassionate Use Program, contact medicineaccess@clinigengroup.com .

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