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Home » Drug Information » FDA Approved Drugs » 2013
Medical Areas: Oncology

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Gilotrif (afatinib)

The following drug information is obtained from various newswires, published medical journal articles, and medical conference presentations.

Company: Boehringer Ingelheim
Approval Status: Approved July 2013
Treatment Area: metastatic non-small cell lung cancer with EGFR mutations

General Information

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.

Clinical Results

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.

Side Effects

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

Mechanism of Action

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.

Literature References

Sequist LV, Yang JC, Yamamoto N, O'Byrne K, Hirsh V, Mok T, Geater SL, Orlov S, Tsai CM, Boyer M, Su WC, Bennouna J, Kato T, Gorbunova V, Lee KH, Shah R, Massey D, Zazulina V, Shahidi M, Schuler M Phase III Study of Afatinib or Cisplatin Plus Pemetrexed in Patients With Metastatic Lung Adenocarcinoma With EGFR Mutations. Journal of Clinical Oncology 2013 Jul 1

Additional Information

For additional information regarding Gilotrif or metastatic non-small cell lung cancer with EGFR mutations, please visit the Gilotrif web page.