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includes suggestions for Afatinib

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Company: Boehringer Ingelheim
Approval Status: FDA Approved July 2013
Specific Treatments: metastatic non-small cell lung cancer with EGFR mutations
Drug: Afatinib



Gilotrif (afatinib) is a tyrosine kinase inhibitor of EGFR (ErbB1), HER2 (ErbB2), and HER4 (ErbB4).

Gilotrif is specifically indicated for the first-line treatment of patients with metastatic non-small cell lung cancer whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations as detected by an FDA-approved test.

Gilotrif is supplied as a tablet for oral administration. The recommended dose is 40 mg orally once daily until disease progression or no longer tolerated by the patient. Gilotrif should be taken at least 1 hour before or 2 hours after a meal.



FDA Approval

The FDA approval of Gilotrif as a first-line treatment was based on a randomized, multicenter, open-label trial in 345 subjects with EGFR mutation-positive, metastatic (Stage IV and Stage IIIb with pleural and/or pericardial effusion) NSCLC. The subjects received Gilotrif 40 mg orally once daily or up to 6 cycles of pemetrexed/cisplatin. Randomization was stratified according to EGFR mutation status (exon 19 deletion vs exon 21 L858R vs other) and race (Asian vs non-Asian). The major efficacy outcome was progression-free survival (PFS). A statistically significant improvement in PFS was demonstrated for in the Gilotrif arm compared with those randomized to the chemotherapy arm: 66.1% versus 60%; median number of months 11.1 versus 6.9 months, respectively.



Adverse events associated with the use of Gilotrif may include, but are not limited to, the following:

  • diarrhea
  • rash/dermatitis
  • acneiform
  • stomatitis
  • paronychia
  • dry skin
  • decreased appetite
  • pruritus



Gilotrif covalently binds to the kinase domains of EGFR (ErbB1), HER2 (ErbB2), and HER4 (ErbB4) and irreversibly inhibits tyrosine kinase autophosphorylation, resulting in downregulation of ErbB signaling.

Source: centerwatch