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On December 31st, Lilly's new breast cancer drug Abemaciclib was approved by NMPA as the second CDK4/6 inhibitor to be listed in China after Abemaciclib (acceptance number: JXHS19001444, JXHS1900145).
Abesili's comorbation is used in association with aromatase inhibitors as hormone-positive (HR), HER2-negative localized late-stage or metastatic post-menovascular female breast cancer patients with initial endocrine therapy, or in patients with advanced or metastatic HR-plus, HER2-female breast cancer.
's approval was based on a Phase III clinical study code-named MONARCH plus in women with post menopaus advanced breast cancer in China, with Queue A joining 306 patients with advanced stage breast cancer who had not previously received systematic treatment for initial endocrine therapy with a besili or placebo combined with nonsteroidal aromatase inhibitors.
group B was treated with 157 patients who progressed after initial endocrine therapy, respectively, with Abesili or placebo combined fluorovis.
results showed that in queue A, the median non-progressive survival time of patients in the Abesili combined nonsteroidal aromatase inhibitor group was longer than in the placebo combined nonsteroidal aromatase inhibitor group (immature vs. 14.7 months, HR:0.499, p s 0.0001).
the progression-free survival time of the Abesili group in queue B was also significantly different from that of the placebo group (11.5 vs. 5.6 months, HR:0.376; p < 0.0001))。
Abersili combined with nonsteroidal aromatase inhibitors or fluvis groups is well-resistant and the safety data are consistent with Abesili's previous findings.
addition, the Phase III clinical study code-named MONARCH3 included 493 patients with post-menopathic hormone-positive HER2-negative progressive breast cancer without systematic treatment.
results showed that the median non-progressive survival time of patients in the Abesili combined nonsteroidal aromatase inhibitor group was longer than that of the placebo combined nonsteroidal aromatase inhibitor group (28.18 vs. 14.76 months, HR=0.540, P=0.000002).
Phase III clinical study, coden named MONARCH2, included 669 patients with hormone-positive HER2-negative progression stage breast cancer who had previously received progression in endocrine therapy.
results showed that the medium progression-free survival time of patients in the Abesili Combined Fluvis group was longer than that of the fluvis group monodride group (16.4 vs. 9.3 months, HR=0.553, P< (0.001), the total survival time of the middle is also longer than that of the fluorovis group single drug group (46.7 vs. 37.3 months, HR s 0.757, P s 0.0137).
was first approved by the FDA in September 2017 and has since been approved in Japan and the European Union, with global sales of $580 million in 2019.
source: Medical Rubik's Cube Next Pharma Abesili has also been developed by Lilly to treat non-small cell lung cancer, pancreatic cancer, prostate cancer and other adaptation certificates.