Leukemia says goodbye to chemotherapy! Imbruvica-ritoxire monoantigen goes to FDA real-time review

The sNDA is being reviewed under the FDA's Real-Time Oncology Review pilot program, which allows the FDA to review data before applicants formally submit an applicationThe aim of the project is to explore a more effective review process to ensure that patients have access to safe and effective treatments as quickly as possible, while maintaining the quality of the reviewIf approved, the milestone would mark the FDA's 11th approval of Imbruvica in six different disease areasImbruvica is a daily oral first Bruton tyrosine kinase (BTK) inhibitor, developed and commercialized by AbbVie's company Pharmacyclics and Johnson and Johnson Biotech's Janssen Biotechnologythis submission is based on the results of the Phase III E1912 study (NCT02048813)The study assessed 529 patients with CLL who were 70 years old and had not received treatment beforeIn the study, these patients were randomly assigned to receive the Imbruvica-rituxisie-treatment regimen (n-354) or the chemical immunotherapy disorder FCR (fluoradarabine-cyclophosphamide-rituxima, n-175)The primary endpoint is Progressless Lifetime (PFS), and the secondary endpoint is total lifetime (OS)results showed significant improvements in PFS and OS in the Imbruvica-litosico-combination group compared to the FCR treatment groupThe security data in the study is consistent with the known security characteristics of ImbruvicaImbruvica is a small molecule drug that is taken orally every day to fight cancer primarily by blocking the bruton tyrosine kinase (BTK) needed to block the proliferation and metastasis of cancer cellsBTK is a key signaling molecule in the B-cell receptor signal complex, which plays an important role in the survival and metastasis of malignant B cells and many other serious decay disordersImbruvica blocks the signaling pathway stoking and spreading of mediated B cells uncontrolledly, helping to kill and reduce the number of cancer cells and slowing the progression of cancerIn clinical trials, monotherapy and combination therapy have shown strong efficacy against a wide range of types of blood system malignanciesSince its launch in 2013, Imbruvica has received 10 FDA approvals for a total of 6 diseases, including 5 B-cell blood cancers and chronic transplant anti-host disease (cGVHD): chronic lymphocytic leukemia (CLL) with or without 17p removal mutation (del17p), accompanied by or without 17p removal mutation (del1) 7p) small lymphocytic lymphocytic sylloma (SLL), Waldenstrom cyanoglobulinemia (WM), previously treated set cell lymphoma (MCL), marginal area lymphoma (MM) that requires systematic treatment and has received at least one anti-CD20 therapy, and chronic transplant resistance to host disease (cGVHD) that failed with one or more systematic therapies, AbbVie and Johnson and Johnson are currently pushing ahead with a massive Imbruvica clinical oncology development projectThe industry is very bullish on Imbruvica's business prospects In June, The pharmaceutical market research firm EvaluatePharma reported that Imbruvica's global sales in 2018 were $4.454 billion, while global sales in 2024 will reach $9.514 billion as the market continues to penetrate and become more resilient original origin: AbbVie Submits Supplemental New Drug Application to U.S FDA For IMBRUVICA ® (ibrutinib) in Combination with Rituximab for The Treatment of Previously Untreated, Younger Adults With Chronic Lemphocy Leukemia