The FDA has approved the first generic versions of Gilotrif (afatinib tablets), opening the door to lower-cost alternatives for patients with certain forms of non-small cell lung cancer (NSCLC).
The newly approved generics are indicated for first-line treatment of metastatic NSCLC patients whose tumors carry non-resistant epidermal growth factor receptor (EGFR) mutations, as identified through an FDA-approved diagnostic test. They are also approved for treating metastatic, squamous NSCLC that has progressed following platinum-based chemotherapy.
The generic afatinib tablets carry the same warnings and precautions as brand-name Gilotrif, including risks of diarrhea, bullous and exfoliative skin disorders, interstitial lung disease (ILD), hepatic toxicity, gastrointestinal perforation, keratitis, and embryo-fetal toxicity. The most commonly reported adverse reactions include diarrhea, rash/acneiform dermatitis, stomatitis, paronychia, dry skin, decreased appetite, nausea, vomiting, and pruritus.
For the EGFR mutation-positive indication, patient selection requires confirmation of non-resistant EGFR mutations in tumor specimens using an FDA-approved test.
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