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Ema Chmp gave a positive opinion for abemaciclib recommending its approval for the treatment of hormone receptor-positive bad cancer (HR +) and negative for the locally advanced human epidermal growth factor receptor (Her2 ) or metastatic and progressed after endocrine therapy. The use of the approved drug in combination with an aromatase inhibitor or with fulvestrant as an initial endocrine therapy or in women who have already received endocrine therapy.
Ema Chmp gave a favorable opinion to the abemaciclib recommending approval for the treatment of hormone receptor-positive bad cancer (HR +) and negative for the growth factor receptor of the patient. locally advanced or metastatic human skin (Her2) that has progressed after endocrine treatment. The use of this drug is approved in combination with an aromatase inhibitor or with fulvestrant as an initial endocrine treatment, or in women who have already received endocrine therapy.
In women in pre or perimenopause, hormone therapy should be combined with a luteinizing hormone agonist (LHRH). Developed by Eli Lilly, the drug will be marketed under the brand name Verzenio
After palbociclib (Pfizer) and ribociclib (Novartis), abemacilicb is the third FDA approved cyclin-dependent kinase inhibitor (CDK) 4/6, a new clbad of drugs for treatment against bad cancer and Hr +.
The approval is based in part on the results of the MONARCH 2 clinical trial. In the study, abemaciclib in combination with fulvestrant was compared to placebo and fulvestrant in a randomized trial with 669 patients with HR-positive bad cancer, HER2-negative that had progressed during endocrine therapy and had not received chemotherapy since the cancer was metastasized. The median progression-free survival was 16.4 months in patients with abemaciclib and fulvestrant vs. 9.3 months in patients with placebo and fulvestrant
In a separate study, the abemaciclib has been evaluated as a stand-alone treatment in 132 patients with HER2 positive and negative metastatic bad cancer, having progressed after hormone and endocrine therapy. chemotherapy. In the study, the target response rate was 19.7% and the median duration of response was 8.6 months
The most common adverse effects of abemaciclib are: diarrhea, neutropenia, leukopenia, nausea, abdominal pain, infections, fatigue, anemia, decreased appetite, vomiting and headache. Abemaciclib is contraindicated during pregnancy because it is teratogenic.
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