Acunivive 60 Injection System and Alectinib Hydrochloride

• Generic Name: ketorolac
• Dosage Forms: injection, solution
• Other Brand Names: Sprix, Toradol

Ketorolac is a nonsteroidal anti inflammatory drug (NSAID).

Ketorolac nasal (for the nose) is used short-term (5 days or less) to treat moderate to severe pain.

Ketorolac may also be used for purposes not listed in this medication guide.

• Generic Name: alectinib
• Dosage Forms: n.a.
• Other Brand Names: Alecensa

Treatment of ALK-positive metastatic NSCLC in patients following failure (secondary to resistance or intolerance) of prior crizotinib therapy (designated an orphan drug by FDA for this use).

Accelerated approval based on tumor response rate and duration of response; continued approval may be contingent on verification and description of clinical benefit in confirmatory studies.

About 3–7% of patients with NSCLC have ALK-positive disease; such patients typically are nonsmokers or light smokers, female, and younger in age, and often have adenocarcinoma.

Long-term therapeutic potential of crizotinib (another ALK inhibitor) is limited by eventual development of secondary resistance and development and/or progression of brain metastases (because of poor distribution of crizotinib into CSF). (See Actions.) Responses to alectinib in patients with crizotinib-refractory ALK-positive metastatic NSCLC have included objective CNS responses.