Afatinib Dimaleate and Gallium ga 68 dotatate Intravenous

• 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: gallium ga 68 dotatate
• Dosage Forms: n.a.
• Other Brand Names:

Gallium Ga 68 dotatate injection is used with a PET scan (positron emission tomography) for localization of somatostatin receptor positive neuroendocrine tumors (NETs) in adults and children.

Gallium Ga 68 dotatate is a radiopharmaceutical. Radiopharmaceuticals are radioactive agents, which may be used to find and treat certain diseases or to study the function of the body's organs.

Gallium ga 68 dotatate is to be given only by or under the direct supervision of a doctor with specialized training in nuclear medicine.