Afanix:

Afatinib is a targeted therapy. Afatinib is classified as a Tyrosine Kinase inhibitor; Epidermal Growth Factor Receptor (EGFR) inhibitor.

Therapeutic Indications

EGFR Mutation-Positive, Metastatic Non-Small Cell Lung Cancer

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

Limitation of Use: The safety and efficacy of Afatinib have not been established in patients whose tumors have other EGFR mutations.

Previously Treated,Metastatic Squamous NSLC

Afatinib is indicated for the treatment of patients with metastatic squamous NSCLC progressing after platinum-based chemotherapy.

Superiority of Afanix:

New phase III data have demonstrated superior improvement in progression-free survival (PFS) with afatinib compared with erlotinib in patients with advanced squamous-cell carcinoma (SCC) of the lung.

• • In the Phase III LUX-Lung 8 (advanced squamous cell carcinoma of the lung) trial, afatinib significantly improved overall survival compared to Erlotinib.

• • Afatinib significantly improved outcomes in treatment-naive patients withEGFR-mutated NSCLC compared with gefitinib, with a manageable tolerability profile.

• • Afatinib results in improved progression-free survival compared with gefitinib.