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September 21, 2020 // -- The European Medicines Agency (EMA) Commission on Human Pharmaceutical Products (CHMP) has issued an active review recommending approval of the anti-PD-1 therapy Opdivo (Odivo, generic name): nivolumab, navuliyu monoantigen) in combination with Yervoy (ipilimumab, Iplimma) and 2 cycles of platinum-containing chemotherapy, first-line treatment of tumors without sensitivity to EGFR mutation or ALC subpopulation metastasis of metastasis non-small cell lung cancer (NSCLC) adult patients.
, CHMP's comments will now be submitted to the European Commission, which usually makes a final review decision within two months.
if approved, it would mark the third EU combined drug adaptation based on Opdivo and Yervoy, following metastatic melanoma and advanced renal cell carcinoma (RCC).
the adaptation application, based on data from the Phase 3 CheckMate-9LA trial, showed that opdivo-Yervoy-chemotherapy significantly extended total survival (OS) in patients with metastasis NSCLC who had not previously been treated.
noted that clinical benefits were observed at all PD-L1 expression levels and histology.
currently, Opdivo-Yervoy-Limited Platinum-containing chemotherapy programmes have been approved by 9 countries for first-line therapeutic metastasis NSCLC.
the end of May this year, the portfolio was approved by the FDA for first-line treatment of metastasis or relapsed NSCLC adult patients without EGFR or ALC genomic tumor amortization.
combination therapy is approved for use in patients with squamous cell and non-squamous cell disease, regardless of PD-L1 expression status.
first-line treatment for lung cancer, two combination therapies based on Opdivo and Yervoy have been approved.
May 15 this year, the FDA also approved Opdivo-Yervoy combination therapy for first-line treatment of metastasis NSCLC patients without EGFR or ALC genomic tumor distortion, tumor expression PD-L1 (-1%).
The Opdivo-Yervoy (OY combination) is the first and only dual immunotherapy approved by the FDA in the United States.
's latest approval also marks the sixth adaptation of the OY portfolio to be approved for five types of cancer in U.S. regulation, including melanoma, renal cell carcinoma, colorectal cancer, hepatocellular carcinoma, and non-small cell lung cancer.
Opdivo-Yervoy is a unique combination of immuno checkpoint inhibitors with potential synergistic mechanisms for 2 different immune checkpoints (PD-1 and CTLA-4) and works in complementary ways to help destroy tumor cells.
Yervoy helps activate and multiply T-cells, while Opdivo helps existing T-cells detect tumors.
, some T cells stimulated by Yervoy also become memory T cells, which can lead to long-term immune responses.
CheckMate-9LA is a global multi-center, randomized, open-label study conducted by Ono Pharmaceuticals in collaboration with Shishi Shiguibo, evaluating opdivo-Yervoy-platinum-containing combination therapy options, platinum-containing dual-drug chemotherapy options for first-line treatment of non-surgical, late-stage or relapsed NSCL patients, regardless of PD-L1 expression and histology.
the study, the trial group received Opdivo (360 mg, once every three weeks, Q3W) and Yervoy (1 mg/kg, once every six weeks, Q6W) plus chemotherapy (2 cycles) for up to two years, or until the disease progressed or beedic.
control group received chemotherapy (up to 4 cycles) followed by optional Pythonsy maintenance therapy (if eligible) until the disease progressed or be toxic.
primary endpoint is total lifetime (OS) in the intentional therapy (ITT) group, and secondary endpoints include progress-free lifetime (PFS), total mitigation rate (ORR), and efficacy assessment based on biomarkers.
October 2019, BMS announced that the study had reached the primary endpoint of Superior Total Lifetime (OS) in a pre-specified medium-term analysis: the Opdivo-Yervoy-2-cycle platinum-containing two-acting chemotherapy treatment group showed a better total lifetime than the chemotherapy group (HR-0.69; 96.71% CI: 0.55-0.87; p-0.0006), regardless of PD-L1 expression or tumor histology (at least 8.1 months of follow-up).
total lifetime (mOS) was 14.1 months (95%CI:13.2-16.2) and 10.7 months (95% CI:9.5-12.5), respectively.
in a follow-up analysis, the mOS risk ratio (HR) increased numerically to 0.66 (95% CI: 0.55-0.80), mOS is 15.6 months (95% CI: 13.9-20.0) and 10.9 months (95% CI:9.5-12.5), respectively.
year, 63% of patients in the Opdivo-Yervoy plus 2-cycle chemotherapy group survived, with 47% in the chemotherapy group.
the study, the total remission rate (ORR) of the Opdivo-Yervoy plus 2-cycle chemotherapy group was 38% (95% CI:33-43) and 25% (95% CI:21-30).
the safety of the 2-cycle chemotherapy program with Opdivo and Yervoy plus 2 cycles reflects the known safety of immunotherapy and chemotherapy groups in first-line NSCLC.
Origin: Bristol Myers Squibb Receives Positive CHMP Opinion Recommending approval of Opdivo (nivolumab) Plus Yervoy (ipilimumab) Combined with Two Cycles of Chemly as First-Line Treatment of Metastatic Non-Small Cell Lung Cancer.