Lenvatinib Mesylate and Rucaparib Camsylate

• Generic Name: lenvatinib
• Dosage Forms: n.a.
• Other Brand Names: Lenvima, Lenvima 8 mg daily-dose, Lenvima 20 mg daily-dose, Lenvima 12 mg daily-dose

Treatment of locally recurrent or metastatic, progressive, radioactive iodine (iodine-131)-refractory differentiated thyroid cancer (designated an orphan drug by FDA for this cancer).

• Generic Name: rucaparib
• Dosage Forms: n.a.
• Other Brand Names: Rubraca

Single-agent therapy for the treatment of deleterious germline and/or somatic BRCA-mutated (as detected by an FDA-approved companion diagnostic test [FoundationFocus CDx BRCA]) advanced ovarian cancer previously treated with ≥2 chemotherapy regimens (designated an orphan drug by FDA for this use). Subgroup analysis suggests overall response rate is higher in patients with platinum-sensitive disease than in those with platinum-resistant disease (66 versus 25%); no responses observed in a limited number of patients with platinum-refractory disease.

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

Women with mutations that result in defective BRCA genes are more likely to develop ovarian cancer. Approximately 10–15% of all cases of ovarian cancer appear to be associated with these hereditary BRCA mutations.