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SEP 11 2026
APPROVED · 18 DAYS AGO

Handa Pharmaceuticals, Inc. — Omcazio (cabozantinib laurylsulfate) $TSE:6620

for advanced renal cell carcinoma; advanced renal cell carcinoma first-line in combination with nivolumab; hepatocellular carcinoma previously treated with sorafenib; previously treated well-differentiated extra-pancreatic neuroendocrine tumors (adult and pediatric ≥12)

NDA · Standard Review

About

Omcazio is a pill containing the drug cabozantinib, which works by blocking several key proteins that help tumors grow their own blood supply and spread. This multi-targeted approach is used to treat several advanced cancers, including well-differentiated neuroendocrine tumors that originate from hormone-producing cells. For patients with this type of tumor, blocking these growth signals may help slow the disease's progression.