The European Union approved AZ/13 Enhertu for the treatment of advanced breast cancer

On January 20, AstraZeneca and The Third Third Party announced that the antibody drug consonant Enhertu (trastuzumab deruxtecan) had been granted conditional approval in the European Union (EU) as a single therapy for the treatment of adult patients with non-removable or metastasis HER2-positive breast cancer who had received two or more anti-HER2 programmes.
same time, Swedish Orphan Biovitrum AB (Sobi™) announced that the European Commission (EC) had approved the expansion of doptelet (avatrombopag) adaptation in all EU member states for the treatment of adult patients with primary immunodeficirative platelet reduction (ITP) that is ineffective in other treatments such as corticosteroids and immunoglobulins.
AZ/First Third Total Enhertu Third-Line Treatment of Advanced Breast Cancer The European Commission's approval is based on positive results from phase II clinical trials of single-armESTINY-Breast01, and approves applications for the drug in accordance with the recommendations of the European Medicines Agency (EMA) Commission on Human Use (CMPH) in December 2020, in accordance with the accelerated evaluation process.
DESTINY-Breast01 is a one-arm, open-label, global, multi-center, two-part Phase II trial designed to test enhertu's safety and effectiveness in patients with HER2-positive non-removable and/or metastasis breast cancer who have previously been treated with testuzumab emtansine (trade name Kadcyla, from Gene Tek).
end point of the trial was objective mitigation rate (ORR), and secondary objectives included remission duration (DoR), disease control rate, clinical benefit rate, progression-free survival rate, and total survival rate.
In the TESTINY-Breast01 trial, Enhertu's treatment of HER2-positive metastasis breast cancer patients showed clinically significant and long-lasting anti-tumor activity, and both patients had previously received two or more HER2-based anti-tumor programs.
specific data, Enhertu showed a confirmed ORR of 61.4 per cent after 20.5 months of medium follow-up, including a full remission rate of 6.5 per cent and a partial remission rate of 54.9 per cent;
safety was assessed in 234 patients with non-removable or metastasis HER2-positive breast cancer who received at least one clinical trial with a dose of 5.4 mg/kg Enhertu.
the most common adverse reactions are nausea, fatigue, vomiting, hair loss, constipation, loss of appetite, anemia, loss of neutral granulocytes, diarrhea, plateplate reduction, coughing, white blood cell reduction and headache.
15.0 per cent of cases of interstitiacal lung disease (ILD) or pneumonia and 2.6 per cent of deaths from ILD.
reported that Enhertu is the first new drug ever approved for breast cancer based on single-arm data from Phase 2 clinical trials in Europe and one of the fastest accelerated evaluation procedures in oncology.
treatment of breast cancer with Enhertu (5.4 mg/kg) has been accelerated in the United States and conditional early approval in Japan.
also approved in both countries for the treatment of HER2-positive non-excisible patients with advanced or relapsed stomach cancer.
the EU approves, AstraZeneta will pay a total of $75 million to the first three as a milestone payment for HER2-positive breast cancer.
Sobi Company Doptlet Therapeutic ITP Doptelet (avatrombopag) is an oral platelet-producing protein-producing perturbation agent (TPO-RA) that simulates the biological effects of TPO, stimulating the development and maturation of cytoprene cells, leading to an increase in platelet counts.
the FDA approved the drug for the treatment of plate reduction in adult chronic liver patients who plan to undergo surgery, and the European Medicines Agency (EMA) approved invasive surgery for severe plate reduction in adult chronic liver patients who plan to undergo surgery.
June 2019, Doptelet was approved by the FDA to treat platelet reduction in adult patients with chronic ITP who had not responded well to previous treatments.
chronic ITP is a rare autoimmune hemorrhagic disease characterized by a small number of plate plates.
incidence of primary ITP in adults was 3.3 per 100,000 adults per year, and the prevalence rate was 9.5 per 100,000 adults1.
source: 1.Doptelet® (avatrombopag) approved in the EU for treatment of ITP 2.Enhertu approvedd in the EU for the treatment of HER2-positive metastatic breast cancer)