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Afatinib
Boehringer Ingelheim Pharmaceuticals.
Afatinib (Tomtovok; BIBW2992) Boehringer Ingelheim Pharmaceuticals., is a selective, potent, irreversible inhibitor of the ErbB family. The compound irreversibly binds to its targets and has potential for broader anti-tumour activity against receptors with acquired mutations which are resistant to first-generation inhibitors. Afatinib is intended for treatment of locally advanced, recurrent or metastatic HNSCC. Afatinib is administered orally at a starting dose of 40mg once daily. The dose may be increased to 50mg and/or reduced to 30mg, or 20mg depending on response and adverse effects
afatinib may provide an additional treatment option for this patient group who currently have limited effective therapeutic options. It has the potential to increase length of survival in this patient group.
Afatinib, Tomtovok, previously Tovok) is a candidate drug against non-small cell lung carcinoma (NSCLC), developed by Boehringer Ingelheim.As of July 2012, it is undergoing Phase III clinical trials for this indication and breast cancer, as well as Phase II trials for prostate and head and neck cancer, and a Phase I glioma trial. Afatinib is not a first-line treatment; it is only used after other therapies have failed.
In October 2010 a Phase III trial in NSCLC patients called Lux-Lung 5 began with this drug.Fall 2010 interim results suggested the drug extended progression-free survivalthreefold compared to placebo, but did not extend overall survival. In May 2012, the Phase IIb/III trial Lux-Lung 1 came to the same conclusion.
Phase II results for breast cancer that over-expresses the protein human epidermal growth factor receptor 2 (Her2-positive breast cancer) were described as promising by the authors, with 19 of 41 patients achieving benefit from afatinib. Double-blind Phase III trials are under way to confirm or refute this finding. Her2-negative breast cancers showed limited or no response to the drug.
DRUG APPROVALS BY DR ANTHONY MELVIN CRASTO
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