Abstral Sublingual Tablet and Cobimetinib Fumarate

• 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: cobimetinib
• Dosage Forms: n.a.
• Other Brand Names: Cotellic

In combination with vemurafenib for treatment of unresectable or metastatic melanoma with b-Raf serine-threonine kinase (BRAF) V600E or V600K mutation (designated an orphan drug by FDA for this use).

FDA-approved in vitro diagnostic test (e.g., cobas 4800 BRAF V600 mutation test) required to confirm presence of BRAF V600E or V600K mutation prior to initiation of therapy.

Limited data suggest greater efficacy (longer progression-free and overall survival, higher objective response rates) in patients with BRAF inhibitor-naive disease versus those with disease progression during prior BRAF inhibitor therapy.