The EU has issued a number of positive comments on drug reviews relating to AZ/Mercadon Lynparza...

On September 21st the European Medicines Agency (EMA) Human Pharmaceutical Products Committee (CHMP) issued a number of positive comments on drug reviews, recommending approval in the European Union of AstraZeneza/Merca East Lynparza (olaparib) combined beva monoantigen for first-line maintenance therapy for patients with ovarian cancer with erotic recombinant defect (HRD) positive, Roche anti-PD-L1 therapy Tecentriq (atezolizumab, art-pearl monoantigen) in the form of avastin (bevacizumab, beva monoantigen) for the treatment of adult patients with non-extinable or metastatic hepatocellular carcinoma (HCC) who have not previously received systematic treatment, as well as the new 100 mg/mL intravenous injection (IV) formula from Alexion company ULTOMIRIS®
01, Lynparza CHMP recommends Lynparza combined with beva monotherapy for advanced epithelial ovarian, fallopian or primary peritiotic cancer patients with advanced epithelial ovarian cancer (FIGOIII.and IV. phase).
These patients responded (fullly or partially) after the completion of first-line platinum chemotherapy combined with beva monotherapy, and detection of mutations in the breast cancer susceptible gene 1/2 (BRCA1/2) and/or genomic instability was associated with an HHRD-positive state.
positive comments from CHMP are based on a subgroup analysis of biomarkers from the double-blind Phase 3 clinical study PAOLA-1, published in the New England Journal of Medicine.
trials showed that Lynparza combined with beva monoantial maintenance therapy reduced the risk of disease progress or death by 67% (risk ratio 0.33; 95% CI 0.25-0.45).
in patients with advanced ovarian cancer who tested positive for HRD, the addition of Lynparza therapy increased progression-free survival (PFS), with a median of 37.2 months, while in patients with beva monotherapy alone, it was 17.7 months.
the PAOLA-1 trial recently updated further data at the 2020 ESMO Network Conference.
results showed that Lynparza's combined bevalza mono-maintenance therapy significantly improved the progress time of secondary disease (PFS2) in HD-positive patients with advanced ovarian cancer, a key secondary endpoint, compared to the single use of beval monoantin.
Lynparza combined with beva monoantin to increase the patient's PFS2 to 50.3 months, while the bevalza monoantin group was 35.3 months.
02, Tecentriq CHMP's positive opinions on anti-PD-L1 therapy Tecentriq in combination with Avastin for adult patients with HCC were based on the results of the Phase 3 IMbrave150 study.
the study, the first Phase III cancer immunotherapy study, showed significant improvements in OS and PFS in non-removable or metastasis HCC patients compared to the standard care drug poly-kinase inhibitor sorafenib.
the trial data showed that the total survival of the Tecentriq-Avastin combined treatment group was significantly extended and the risk of death was reduced by 42% compared to the Solafini group (HR=0.58,95% CI:0.42-0.79, p=0 .0006), significantly longer disease progressity (PFS), reduced risk of disease progress or death by 41% (HR=0.59, 95% CI: 0.47-0.76, p<0.0001).
May this year, tecentriq-Avastin was approved by the FDA to treat non-removable or metastasis HCC patients who had not previously received systematic treatment.
it is worth mentioning that the Tecentriq-Avastin combination is the first cancer immunotherapy treatment approved for the treatment of non-excisive or metastasis HCC.
03, ULTOMIRIS ULTOMIRIS is the first and only long-acting C5 inhibitor to be given every 8 weeks to treat two ultra-rare diseases, PNH and atypical hemolytic uremia syndrome (aHUS).
for children weighing less than 20 kg, intravenous injections are given every four weeks after taking a certain dose.
ULTOMIRIS 10 mg/mL reduces the average annual infusion time by approximately 60% compared to the previous formula ULTOMIRIS 10 mg/mL, while providing considerable safety and effectiveness, an advance in treatment experience for patients with aHUS and PNH.
treatment does not last more than 6 hours per year after using ULTOMIRIS 100 mg/mL.
this CHMP positive opinion is based on a comprehensive chemical, manufacturing and control (CMC) report and complementary clinical data set.
data set showed that safety, pharmacodynamics and immunogenicity were comparable after the use of ULTOMIRIS 10 mg/mL and 100 mg/mL.
, the data set showed no significant effect on the effectiveness measurement of the average lactic acid dehydrogenase (LDH) levels in both formulations.
's new proposed formula requires a time of 0.4-1.3 hours (25-75 minutes) depending on weight, which is more than half as long as the current 10 mg/mL intravenous infusion formula, which ranges from 1.3-3.3 hours (77-194 minutes).
Alexion plans to submit to U.S. and European Union drug regulators in the third quarter of 2021 a combination of ULTOMIRIS off-skin formulations and devices for PNH and aHUS treatments, which allow patients to manage their medications at home, and is currently conducting Phase 3 clinical studies and 12 months of safety data collection.
source: 1.Lynparza recommended for approval in EU by CHMP as 1st-line maintenance treatment with bevacizumab for HRD-positive advanced ovarian cancer 2.Alexion Receives CHMP Positive Opinion For New Advanced Development of ULTOMIRIS ® with Great Reduced Infusion Time 3.Roche receives positive CHMP opinion for Tecentriq with with a lot of Avastin for the. Treatment of people with the most common form of liver cancer Original title: EU issued a number of positive comments on drug reviews, involving AZ/Merca East Lynparza, Roche Tecentriq ...