Advanced kidney cancer "immune and targeted" first-line treatment! The Opdivo-Cabometyx program was reviewed by the FDA as a priority, beating Sutt!

October 21, 2020 // -- BMS and partner Exelixis recently jointly announced that the U.S. Food and Drug Administration (FDA) has accepted a supplementary biologics licensing application (sBLA) and a new drug application (sN) DA), a combination of the anti-PD-1 therapy Opdivo (Odivo, generic name: nivolumab, navoliyu monoanti) and the targeted anticancer drug Cabozantinix (cabozantinib) for the treatment of patients with advanced renal cell carcinoma (RCC).
fda gave priority to both applications and designated a target date for the Prescription Drug Use Fee Act (PDUFA) as February 20, 2021.
these applications are based on the results of the Key III CheckMate-9ER trial.
data show that in patients with advanced RCC who had not previously been treated, the first-line standard care drug Suttent (Sotan, generic name: sunitinib, schoinistinib, a tyrosine kinase inhibitor, developed by Pfizer) In contrast, the "Immune plus Target" scheme Opdivo-Cabometyx showed significant improvements at all ends of the efficacy, including total lifetime (OS), progress-free lifetime (PFS), objective mitigation rate (ORR), and mitigation duration (DOR).
specific data are: (1) OS, opdivo and Cabometyx group compared to the Sutt group significantly reduced the risk of death by 40% (HR s 0.60; 98.89% CI: 0.40-0.89; p s 0.0010), 2 groups of the middle OS did not reach.
(2) study of the main endpoint PFS, the Opdivo-Cabometyx group doubled compared to the Sutt group (medium PFS: 16.6 months vs 8.3 months; HR=0.51; 95% CI:0.41-0.64; p<0.0001).
(3) ORR, the Opdivo-Cabometyx group is twice (56% vs 27%) and the full mitigation rate (CR) is higher (8% vs 5%).
(4) DOR, the Opdivo-Cabometyx group is longer than the Sutt group (middle DOR: 20.2 months vs 11.5 months).
it is worth noting that all these key outcomes are consistent in the pre-designated International Alliance for Metastatic Kidney Cancer Database (IMDC) risk and in the PD-L1 subgroup.
studies, Opdivo and Cabometyx were well-to-do, reflecting the known safety of immunotherapy and tyrosine kinase inhibitors (TKI) in advanced first-line therapy RCC.
based on the National Cancer Comprehensive Network Cancer Treatment Function Assessment (NCCN-FACT) Kidney Symptoms Index 19 (FKSI-19), at most points, patients treated with Opdivo-Cabometyx had significantly better health-related quality of life than those treated with Sutt.
cancer (photo: vecteezy.com) Renal cell carcinoma (RCC) is the most common type of kidney cancer in adults, killing more than 140,000 people worldwide each year.
incidence of RCC in men is about twice that of women, with the highest incidence in North America and Europe.
, patients diagnosed with metastatic or advanced kidney cancer have a five-year survival rate of only 12.1%.
recent years, although some treatment progress has been made, additional treatment options are needed to prolong the life.
CheckMate-9ER results clearly demonstrate that opdivo and Cabometyx "immune plus targeted" combined treatment options for patients with advanced or metastasis RCC have clinically significant improvements in key efficacy indicators for progressive survival (PFS) and total lifetime (OS).
addition, Opdivo and Cabometyx have good safety.
If approved, Opdivo and Cabometyx's "Immune Plus Targeting" combination will provide an important, new first-line treatment for previously untreated groups of patients with advanced or metastatic renal cell carcinoma (RCC).
Cabometyx's active pharmaceutical ingredient is cabozantinib, a tyrosine kinase inhibitor (TKI) that plays an anti-tumor role by targeting the suppression of MET, VEGFR2, and RET signaling path pathlines, killing tumor cells, reducing metastasis and inhibiting angiogenesis.
Cabometyx has been approved for the treatment of patients with advanced renal cell carcinoma (RCC) in the United States, the European Union, Japan and other countries and regions of the world, as well as patients with hepatocellular carcinoma (HCC) who have previously been treated with sorafenib.
Opdivo is a programmed death-1 (PD-1) immuno-checkpoint inhibitor designed to uniquely use the body's own immune system to help restore the anti-tumor immune response by blocking the interaction between PD-1 and its liens.
was first approved in Japan in July 2014 and is the world's first approved PD-1 immunotherapy.
, Opdivo has become an important treatment option for many cancers.
for the treatment of renal cell carcinoma (RCC), Opdivo has approved the following adaptations: (1) for patients with advanced RCC who have previously been treated with anti-angiogenesis therapy;
() Origin: U.S. Food and Drug Administration Accepts for Priority Review applications for OPDIVO? (nivolumab) in Group with CABOMETYX? (cabozantinib) in Advanced Renal Cell Carcinoma