Exkivity

The FDA Accelerated Approval Program allows a medication to be approved faster than usual if the medication helps fill an unmet medical need and if it treats a serious condition. These approvals are based on a surrogate endpoint, which is a marker (sign) that's believed to predict a clinical benefit. For example, tumor shrinkage is a surrogate endpoint for cancer survival. After a medication receives accelerated approval, the manufacturer is still required to complete additional studies to make sure the treatment is beneficial. Otherwise, it's possible the medication could lose its approval status and be taken off the market.

Exkivity (mobocertinib) is used to treat adults with advanced NSCLC with a specific mutation (change in DNA) called EGFR exon 20 insertion mutations. You can find out if you have this mutation through an FDA-approved genetic test that your provider will order for you. Exkivity (mobocertinib) should only be used if your condition wasn't treated successfully with a first-choice treatment option, such as carboplatin or cisplatin-based treatments.

The typical starting dose is 160 mg (4 capsules) by mouth once daily with or without food. Your dose might be lowered if you experience certain side effects or if you're taking certain medications.