Afatinib (3) – Giotrif®

Non-small cell lung carcinoma (NSCLC), squamous cell histology

Characteristics

Start date 01.05.2016 – Marketing authorisation: 31.03.2016
Resolution 20.10.2016
INN Afatinib
Brand name Giotrif®
Pharm. company Boehringer Ingelheim Pharma GmbH & Co. KG
G-BA Procedure ID D-226
ATC code L01EB03 EGFR tyrosine kinase inhibitors (L01EB)
ICD-10 codes (AIS) C34.0Malignant neoplasm of carina, C34.1Malignant neoplasm of upper lobe, bronchus or lung, C34.2Malignant neoplasm of middle lobe, bronchus or lung, C34.3Malignant neoplasm of lower lobe, bronchus or lung, C34.8Malignant neoplasm of overlapping sites of bronchus and lung, C34.9Malignant neoplasm of unspecified part of bronchus or lung
Alpha-ID codes (AIS) I111155Carcinoma of the upper lobe bronchus, I116693Non-small cell lung cancer, I24595Carcinoma of the main bronchus, I30015Lung carcinoma of the middle lobe, I30021Lung carcinoma of the lower lobe, I30022Malignant neoplasm of the bronchi and lungs, overlapping several sub-areas
DDD 40 mg O
Therapeutic area Oncological diseases Non-small-cell lung carcinoma (NSCLC)
Reason for procedure New therapeutic indication

Therapeutic indication of the resolution

GIOTRIF as monotherapy is indicated for the treatment of adult patients with locally advanced or metastatic NSCLC of squamous histology progressing on or after platinum-based chemotherapy.
Subpopulation Indication Comparator
a) Patients with locally advanced and/or metastatic NSCLC with squamous histology with progression during or after platinum-based chemotherapy for whom therapy with docetaxel is indicated Docetaxel
b) Patients with locally advanced and/or metastatic NSCLC with squamous histology with progression during or after platinum-based chemotherapy for whom therapy with docetaxel is not indicated Best-Supportive-Care

Studies and Results

No. of studies
(best subpopulation) 		1 (LUX-Lung 8)
Study design
(best subpopulation) 		H2H vs. non-ACT + no ITC
Meta analysis
(best subpopulation) 		no
Reason for dividing into subpopulations (G-BA) Patient eligibility

  • Clinical trials
    • This was a randomised, actively controlled, open-label, multicentre Phase IIItrial in which afatinib is directly compared with erlotinib in patients with locally advanced or metastatic NSCLC of squamous cell histology who have experienced progression during or after platinum-based chemotherapy and for whom second-line treatment is indicated.

a) Patients with locally advanced and/or metastatic NSCLC with squamous cell histology who have experienced disease progression during or after platinum-based chemotherapy and for whom treatment with docetaxel is indicated

  • For patients with locally advanced and/or metastatic NSCLC with squamous cell histology who have experienced progression during or after platinum-based chemotherapy, additional benefit is not proven compared with the appropriate comparator therapy, docetaxel.
  • The LUX-Lung 8 study does not allow for a comparison of afatinib with docetaxel, the appropriate comparator therapy specified by the G-BA; furthermore, the pharmaceutical manufacturer has not provided any evidence from which therapeutic equivalence between erlotinib and docetaxel in this therapeutic indication can be reliably inferred.

b) Patients with locally advanced and/or metastatic NSCLC with squamous cell histology who have experienced progression during or after platinum-based chemotherapy, for whom treatment with docetaxel is not indicated

  • The pharmaceutical company has not provided any data for the assessment of the additional benefit of afatinib in adult patients with locally advanced or metastatic NSCLC with squamous cell histology who have experienced progression during or after platinum-based chemotherapy and for whom no further chemotherapy is indicated.
  • Consequently, additional benefit from afatinib is not proven for this patient group.

Courtesy translation only, please refer to the German original.

Associated procedures



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