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CABOCIP (Cipla Australia Pty Ltd)
Product name
CABOCIP
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
138 (255 working days)
Active ingredients
cabozantinib (S)-malate
Registration type
New generic medicine
Indication
Renal cell carcinoma (RCC)
[TRADE NAME} is indicated as monotherapy for the treatment of advanced renal cell carcinoma (RCC):
- in treatment-naïve adults with intermediate or poor risk
- in adults following prior treatment with vascular endothelial growth factor targeted therapy.
[TRADE NAME} in combination with nivolumab is indicated for the first-line treatment of advanced renal cell carcinoma.
Hepatocellular carcinoma (HCC)
[TRADE NAME} is indicated as monotherapy for the treatment of hepatocellular carcinoma (HCC) in adults who have previously been treated with sorafenib.
Differentiated thyroid carcinoma (DTC)
[TRADE NAME} is indicated as monotherapy for the treatment of adult and paediatric patients aged 12 years and older with locally advanced or metastatic differentiated thyroid carcinoma (DTC) that has progressed during or after prior VEGFR-targeted therapy and who are radioactive iodine (RAI) refractory or ineligible.
Neuroendocrine Tumours (NET)
[TRADE NAME} is indicated for the treatment of adult patients with locally advanced/unresectable or metastatic, well-differentiated extra-pancreatic (epNET) or pancreatic (pNET) neuroendocrine tumours who have progressed on at least one prior systemic therapy other than a somatostatin analogue.
Registration process
First generic
First approval of a medicine that contains the same active ingredient as and is bioequivalent to an existing medicine