Afatinib Dimaleate and Lanreotide Acetate

• Generic Name: afatinib
• Dosage Forms: n.a.
• Other Brand Names: Gilotrif

First-line treatment of metastatic NSCLC in patients with tumors positive for nonresistant epidermal growth factor receptor (EGFR) mutations (e.g., exon 19 deletions [del19], exon 21 substitution [L858R] mutations) as detected by an FDA-approved diagnostic test (designated an orphan drug by FDA for this use). Nonresistant EGFR mutations are those where efficacy of afatinib may be predicted by a clinically meaningful reduction in tumor size at the recommended dosage of the drug and/or inhibition of cellular proliferation or EGFR tyrosine kinase phosphorylation is expected at afatinib concentrations sustainable at the recommended dosage.

Treatment of metastatic squamous NSCLC that has progressed following therapy with platinum-based chemotherapy (designated an orphan drug by FDA for this use).

Safety and efficacy not established in patients with resistant EGFR mutations.

• Generic Name: lanreotide
• Dosage Forms: n.a.
• Other Brand Names: Somatuline Depot

Long-term treatment of acromegaly in patients who have had inadequate responses to or are not candidates for surgical resection and/or radiotherapy (designated an orphan drug by FDA for this use).

Goal of therapy is to normalize concentrations of growth hormone (GH) and insulin-like growth factor 1 (IGF-1).

Improves certain manifestations of acromegaly (asthenia, joint pain, swelling of extremities, excessive perspiration, headache).