Johnson and Johnson BTK inhibitor Ibtini Unilitoxi monoantigen monotherapy CLL has been approved in Europe.

Introduction: Jansen Imbruvica (Ibtini) Unilica Rituximab first-line treatment of adult patients with chronic lymphocytic leukemia (CLL) has been approved for listing in the European Union.
recently, Johnson and Johnson's Jansen announced that the European Commission (EC) has granted its Imbruvica (Ibtinie) Unituximab first-line treatment of adult patients with chronic lymphocytic leukemia (CLL).
decision is based on the results of Phase III E1912 Study (NCT02048813).
the study assessed 529 patients aged 70 who had not previously been treated.
the study, these patients were randomly assigned to receive Imbruvica-lysica monoantigen (IR, n-354) or chemical immunotherapy (FCR, fluoridalamide-cyclophosphamide-lytoxid, n-175).
end point is progress-free lifetime (PFS) and secondary endpoint is total lifetime (OS).
results showed significant improvements in both PFS and OS in the Imbruvica-lyxi monoantigen therapy group compared to the FCR treatment group.
data in this study are consistent with the known security characteristics of Imbruvica.
follow-up results from the study were published at the 2019 annual meeting of the American Society of Hematology (ASH).
48 months of follow-up, 73% of patients in the IR programme group were still receiving Imbruvica treatment, with a medium treatment time of 43 months (range: 0.2-61 months).
the median time for disease progression or death after imbruvica was stopped was 23 months.
compared to the FCR programme group, the IR programme group showed consistently superior PFS benefits (HR=0.39 (95% CI: 0.26-0.57), p.0001), and a 61% reduction in the risk of disease progress or death.
addition, compared to the FCR programme group, the IR programme group showed continuous excellent OS benefits (HR=0.34; 95% CI:0.15-0.79; p=0.009), with a 66% reduction in risk of death.
safety, the IR programme group and the FCR programme group observed 70 per cent and 80 per cent of patients with level 3 and higher treatment-related adverse events (TEAE) (ratio ratio of 0.56; 95 per cent CI: 0.34-0.90; p=0.013), respectively).
Ibtini is the first generation of oral small molecule BTK inhibitors, pioneered by Johnson and Johnson and Pharmacyclics (acquired by AbbVie), which was approved by the FDA in 2013 as a second-line treatment for myoblastoma, and has since expanded.
Domestically, Ibdinib (commodity name: Eythaya ®) was approved in 2017 for the treatment of adult chronic CLL/small lymphocyte lymphoma (SLL) patients who have received at least one treatment in the past, as well as patients with set cell lymphoma (MCL) who have received at least one treatment in the past, as innovative targeted oral drugs for the treatment of lymphoma subsypes.
Ibdini retails for 48,600 yuan (140mg x 90 capsules/box) in the domestic market.
in October 18, Ibdini negotiated a health-care payment of 17,010 yuan (140mg x 90 capsules/box) to be included in the health-care list.
, four BTK inhibitors have been approved worldwide, and the other three are second-generation BTK inhibitors: AstraZeneca's Calquence, Brukinsa of Baiji and Velexbru of Ono Pharmaceuticals.
second-generation BTK inhibitors are highly specific to inhibit BTK, effectively reducing the non-targeted inhibition of the first generation of Imbruvica.
Calquence Acatini is an irreversible second-generation BTK inhibitor, developed by AstraZeneca and launched in the U.S. in October 2017, and the second BTK inhibitor to go on sale.
highly specific compared to Ibdinib, with little inhibition of EGFR, TEC and ITK, making it less toxic.
the advantages of good efficacy, small side effects and low price also make Acatini have greater market potential.
Brukinsa Zebtini is another selective BTK inhibitor, developed by Baiji Shenzhou.
clinical activity and tolerance have been confirmed in early studies of R R B cell malignancies.
as a follow-up drug, Zebtinib should be superior in safety and effectiveness to Ibtini and acatinib, although it avoids target (concept) validation.
, which was originally approved by the FDA in November 2019, became the first new cancer drug developed by a Chinese company and approved by the FDA, and was awarded accelerated approval, breakthrough therapy and orphan drug identification.
On June 3 this year, Zebtini capsules (trade name: Bai Yueze) were approved for sale in China for adult MCL patients who have received at least one treatment in the past and adult chronic CLL/SLL patients who have received at least one treatment in the past.
Velexbru, similar to Acatini, is a highly selective BTK inhibitor developed by Ono Pharmaceuticals and is currently approved only in Japan.
Tirabrutinib has not clinically detected significant diarrhea, joint pain, or arrhyth arrhythmics, giving R/R CLL patients an advantage in long-term treatment and a toned alternative to Ibdinib.
addition, the domestic side also has Novarce Jianhua's Obudini listing approval process is on schedule, is expected to be approved by the State Drug Administration in the fourth quarter of the listing.
the approved adaptive disorders were relapsed recurring resoicable CLL/SLL and relapsed recurring re-treatable MCL, respectively.
the company is also exploring adaptive expansion and co-medication opportunities for BTK inhibitors.
now available listed BTK inhibitor drugs are mainly targeted at tumor-related allergies, other development pipelines began to gradually focus on the field of immunity and inflammation and other applications.
, for example, Roche is studying BTK inhibitors for urticaria that has entered Phase 3 clinical trials, and the treatment of rilzabrutinib developed by Principia Biopharma has moved to the final clinical stage.
these may open up a new blue sea of BTK inhibitors and squeeze more market share.
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