Omcazio approved as new cabozantinib option across four oncology indications
- Sponsor
- Handa Pharmaceuticals, Inc. $TSE:6620
- Drug
- Omcazio · cabozantinib laurylsulfate
- Indication
- advanced renal cell carcinoma; advanced renal cell carcinoma first-line in combination with nivolumab; hepatocellular carcinoma previously treated with sorafenib; previously treated, unresectable, locally advanced or metastatic, well-differentiated extra-pancreatic neuroendocrine tumors (adult and pediatric ≥12 years)
FDA granted final approval to Handa Oncology's Omcazio (cabozantinib laurylsulfate) capsules under 505(b)(2), covering advanced RCC, HCC, and previously treated extra-pancreatic NETs.
What this means
Cabozantinib is a widely used oral cancer pill that blocks the signaling pathways cancer cells depend on to grow and to build blood vessels. It is currently sold by Exelixis as Cabometyx and Cometriq, but those products must be taken on an empty stomach because food changes how much drug the body absorbs. Handa Oncology's new version, Omcazio, uses a different salt form of the same drug and was approved by the FDA on Sept 11, 2026 for four cancer settings: advanced kidney cancer (renal cell carcinoma) alone, advanced kidney cancer first-line in combination with nivolumab (Opdivo), liver cancer (hepatocellular carcinoma) after prior treatment with sorafenib, and previously treated well-differentiated neuroendocrine tumors outside the pancreas in adults and children 12 and older. Because Omcazio was shown not to have a clinically meaningful food effect, patients can take it with or without food.