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Boehringer Ingelheim. (2/28/17). "Press Release: Giotrif (afatinib) Becomes First Second-Generation ErbB Family Blocker Approved for Lung Cancer in China".

Organisations Organisation Boehringer Ingelheim (Group)
  Organisation 2 CFDA (Chinese Food and Drug Administration)
  Today National Medical Products Administration of China (NMPA, formerly CFDA)
  Group China (govt)
Products Product Giotrif®
  Product 2 oncology

Boehringer Ingelheim today announced the approval of afatinib* (Giotrif®), the first irreversible second-generation ErbB family blocker for lung cancer in China, for patients with distinct types of non-small cell lung cancer (NSCLC).

Afatinib has received Imported Drugs License (IDL) status by the China Food and Drug Administration (CFDA) for both:

> Locally advanced or metastatic EGFR mutation-positive lung cancer patients who have not received any prior therapy with tyrosine kinase inhibitors (TKIs)

> Patients with locally advanced or metastatic squamous cell carcinoma (SqCC) of the lung whose disease has progressed on or after treatment with platinum-based chemotherapy.

The approval of afatinib has the potential to drive progress in lung cancer treatment in China; compared to global incidence figures, China accounts for approximately one third of all new global lung cancer diagnoses.1 Furthermore, EGFR mutations are found in 40-50% of Asian lung cancer patients,2-5 compared to 10-15% of Caucasian patients,6,7 which underscores the importance of this approval for patients in China.

Afatinib is the first and only second-generation ErbB family blocker approved in China, which could provide substantial benefit for the large number of Chinese NSCLC patients with EGFR mutations who have yet to receive treatment and for those patients with SqCC of the lung, the second largest sub-type of NSCLC, representing approximately 20-30% of NSCLC cases.8,9


*Afatinib is approved in a number of markets, including the EU, Japan, Taiwan and Canada under the brand name Giotrif®, in the US under the brand name Gilotrif® and in India under the brand name Xovoltib® for use in patients with distinct types of EGFR mutation-positive NSCLC. Afatinib is also approved in the EU, US and other markets for the treatment of patients with advanced SqCC of the lung whose disease has progressed (on or) after treatment with platinum-based chemotherapy. Afatinib is under regulatory review by health authorities in other countries worldwide. Registration conditions differ internationally, please refer to locally approved prescribing information.


1. GLOBOCAN 2012. Access January 2017.
2. Mitsudomi T et al. Mutations of the epidermal growth factor receptor gene predict prolonged survival after gefitinib treatment in patients with non-small cell lung cancer with postoperative. J Clin Oncol 2005;23:2513-2520.
3. Chou TY et al. Mutation in the Tyrosine Kinase Domain of Epidermal Growth Factor Receptor Is a Predictive and Prognostic Factor for Gefitinib Treatment in Patients with Non–Small Cell Lung Cancer. Clin Cancer Res 2005;11:3750-3757.
4. Seo JS et al. The transcriptional landscape and mutational profile of lung adenocarcinoma. Genome Res. 2012;22:2109-2119.
5. Yang SH et al. Mutations in the tyrosine kinase domain of the epidermal growth factor receptor in non-small cell lung cancer. Clin Cancer Res 2005;11:2106-2110.
6. National Comprehensive Cancer Network. NCCN Clinical Practice Guidelines in Oncology: non-small cell lung cancer, version 1, 2015.
7. Quest Diagnostics – Lung Cancer Mutation Panel (EGFR, KRAS, ALK); Available at: Accessed November 2016.
8. Travis WD. Clin. Chest Med. 2011;32(4):669–692.
9. Hall PE et al. Future Oncol. 2015;11(15):2175-91.

Susanne Granold

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Record changed: 2023-06-05


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