Lung cancer first-line new program! BMS star immune combination Opdivo-Yervoy combined with limited course of chemotherapy protocol snare snare snare snr in the US and EU goes into review!

09 April 2020 /
Biovalley BIOON/ -- The U.S Food and Drug Administration (FDA) has accepted an application for a supplementary biologics license (BLA) to treat The Opdivo," a therapeutic anti-PD-1 therapy Generic name: nivolumab, Navu-mono- and joint Yervoy (ipilimumab, eprimamma) and limited course of platinum-double chemotherapy, first-line treatment of non-surgically rectructable, advanced or recurrent non-small cell lung cancer (NSCLC) FDA has granted the BLA priority review and fast-track eligibility, and has designated a target date for the Prescription Drug User Charge Sfa (PDUFA) as August 6, 2020 in addition , the European Medicines Agency (EMA) has accepted applications for Class II changes in opdivo and Yervoy's joint limited course of chemotherapy for the treatment of the same indications mentioned above, and has initiated a centralized review process Previously, in March 2020, Ono Pharmaceuticals, in partnership with BMS, submitted a supplementary application in Japan for the first-line treatment of The Opdivo and Yervoy's combined limited course of chemotherapy, NSCLC January 2020, the Opdivo-Yervoy combination of first-line treatment of patients with no EGFR or ALK genomic metastatic or recurrent non-small cell lung cancer (NSCLC) patients with complementary biological productlicensation (BLA) was accepted by the U.S FDA and is undergoing priority review, with the target date of The Prescription Drug User Charge (PDUFA) date of May 15, 2020 The application is based on the results of Part 1 of the Phase III CheckMate-227 study The data showed that the Opdivo-Yervoy combination programme significantly extended total lifetime (OS) compared to chemotherapy it is worth noting that on the EU side, the BMS withdrew the application at the end of January The reason is that the EMA Human Medicine Products Committee (CHMP) believes that BMS has made a number of programmatic changes to the clinical trial involved in the application, and that despite the completeness of the patient data, the application cannot be fully evaluated The BMS said it was disappointed by CHMP's comments and said it had no plans to resubmit the application in the EU application for a combination of opdivo-Yervoy combined limited course of chemotherapy is based on the results of the critical Phase III CheckMate-9LA study This is a global multi-center, random, open label research, conducted by Ono Pharmaceuticals in collaboration with Baishi Meishi guibao, evaluated the opdivo-Yervoy-containing two-drug chemotherapy (2 cycles) combination therapy program, the first-line treatment of platinum-based double-drug chemotherapy treatment non-surgical, late-stage or recurrent NSCLC patients, regardless of PD-L1 expression and histology In the study, the team received Opdivo (360mg, every three weeks, Q3W) and Yervoy (1mg/kg, q6W) and chemotherapy (2 cycles) for up to two years, or until the disease progressed or was unacceptable The control group received chemotherapy (up to 4 cycles) followed by an optional pemerace maintenance therapy (if conditions are met) and treated until the disease progresses or is toxic The primary endpoint is total survival (OS) in the intentional therapy (ITT) group, and the secondary endpoint seinevers include no progression survival (PFS), total remission rate (ORR), and evaluation of efficacy based on biomarker October 2019, BMS announced that the study reached the primary endpoint of superior total survival (OS) in a pre-specified mid-term analysis: there was a significant improvement in OS in the Opdivo-Yervoy-Yervoy-Chemotherapy group compared to the chemotherapy group In this study, the safety of Opdivo combined with low-dose Yervoy and 2-cycle chemotherapy reflected the known safety of immunotherapy and chemotherapy components in first-line NSCLC Dr Sabine Maier, head of breast cancer development at BMS, said: "Despite advances in treatment in recent years, there are still serious unmet medical needs for additional innovative treatments for lung cancer patients worldwide FDA and EMA are an important milestone for lung cancer patients, and we look forward to working with regulators to bring the first and only dual immunotherapy plus limited chemotherapy regime to patients as soon as possible "
Opdivo is a programomatic death-1 (PD-1) immunocheckpoint inhibitor that uniquely uses the human autoimmune system to help restore the immune response to anti-
tumors
by blocking the interaction between PD-1 and its ligands Opdivo was the first PD-1 immunotherapy approved in Japan in July 2014 At present, Opdivo has become an important treatment option for a wide range of cancers Opdivo and Yervoy are tumor immunotherapy (I-O), through the target immune system of different regulatory elements, the use of the body's own immune system to fight tumors, where Opdivo targeted blocking PD-1/PD-L1 pathway, Yervoy targeted blocking CTLA-4 At present, Persimmon Squibb is developing opdivo-Yervoy immunocombination for the treatment of a variety of types of tumor Opdivo-Yervoy is the only FDA-approved dual immunotherapy in the United States that has potential synergies for two different immunological checkpoints (PD-1 and CTLA-4) and works in a complementary manner To date, the Opdivo-Yervoy combination has been approved by the FDA for the treatment of 4 types of cancer (
melanoma , kidney cell carcinoma, colorectal cancer, hepatocellular carcinoma) (biovalleybioon.com) original origin: Britol Myer Squibb Announce Acceptance Form of U.S and EU Filingy for Opdivo (nivolumab) Plu Yervoy (ipiliab) Combined with Limited in Firt-Line Cancer