Abstral Sublingual Tablet and Afatinib Dimaleate

• Generic Name: fentanyl
• Dosage Forms: sublingual tablet
• Other Brand Names: Abstral, Fentora, Subsys, Actiq, Duragesic, Ionsys, Lazanda, Onsolis, Sublimaze

Abstral (fentanyl) is an opioid pain medication. An opioid is sometimes called a narcotic.

Abstral sublingual tablets are used to treat "breakthrough" cancer pain that is not controlled by other medicines.

The sublingual tablet is placed on the floor of the mouth under your tongue (sublingual) and allowed to dissolve.

Abstral is not for treating pain that is not cancer-related.

• 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.