Alectinib Hydrochloride and Dexbrompheniramine and Pseudoephedrine Sustained-Release Tablets

• 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.

• Generic Name: dexbrompheniramine / pseudoephedrine
• Dosage Forms: liquid
• Other Brand Names: Conex, Drixoral Cold and Allergy, Drexophed SR, Desihist SA, Duomine, Dexophed, Disobrom, Disophrol, Drixoral, 12 Hour Cold, Dexaphen SA, Dixaphedrine, Drixomed, Pharmadrine, Ala Hist PE, Ala-Hist PE, Drixoral Sinus

• It is used to treat nose stuffiness.
• It is used to ease allergy signs.