Tags : Cabometyx

Takeda Report Submission of NDA to MHLW for Cabometyx (cabozantinib)

Shots: The NDA is based on two clinical studies, P-III CELESTIAL (XL184-309) & P-II Cabozantinib-2003 study assessing Cabometyx in patients with advanced HCC prior treated with systemic therapy In 2017, Exelixis and Takeda collaborated for Cabometyx in Japan, under which Exelixis will receive ~$10M milestones following the NDA submission for HCC, expected to receive in […]Read More

Takeda Files NDA for Cabometyx (cabozantinib) to MHLW for Advanced

Shots: The submission is based on METEOR, CABOSUN and Takeda’s bridging study. METEOR & CABOSUN studies result assessing Cabometyx vs everolimus & sunitinib in patients with RCC + prior treated with at least one VEGFR-TKI inhibitor & untreated advanced RCC with intermediate/poor-risk disease respectively In Q2’19, Exelixis is expected to receive $10M as milestones from […]Read More

Ipsen’s Cabometyx Receives Health Canada’s Approval for the Treatment of

Shots: Approval of Cabometyx (cabozantinib) is based on results of the P-III METEOR trial assessing Cabometyx vs everolimus for advanced (RCC) previously received vascular endothelial growth factor (VEGF) targeted therapy, demonstrated significant and clinical improvement in OR, PFS, ORR Cabometyx received priority review status from Health Canada further assisted its approval. In 2017, the US […]Read More

Exelixis’ Cabometyx (cabozantinib) Recommended by the NCCN in its Clinical

Shots: Guidelines for Kidney Cancer: CABOMETYX (TKi) is recommended for 1L RCC patients in the poor- and intermediate-risk groups (Category 2A), 1L treatment for favourable-risk patients (Category 2B), and for previously treated patients (Category 1) The (Category 2A) guidelines are based on P-II CABOSUN trial (N=157) in (ratio 1:1) administering cabozantinib (60mg qw)/sunitinib (50mg qw,4 […]Read More