FDA Approves Vabysmo, The First Bispecific Antibody For The Eye!
The US Food and Drug Administration has approved Vabysmo (faricimab-svoa), for the treatment of wet age-related macular degeneration (AMD) and diabetic macular oedema (DME).
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New Drug Expected For Patients With Low HER2 Expression, FDA Grants Priority Review Status To Enhertu
The FDA granted priority review status to Enhertu (DS-8201) for the treatment of patients with HR-positive, low HER2-expressing breast cancer, and Enhertu has enabled these patients to remain disease-free for an average of 10.1 months, with an average overall survival time of nearly two years. A decision on approval is expected to be made in the fourth quarter of this year.
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Newly Approved Targeted Drug Makes 79% Of Patients' Tumours Disappear Altogether, This Type Of Blood Tumour Is Saved!
The US FDA has approved pemigatinib, the first targeted drug to date for patients with specific mutated blood tumours, and the results of the study show that the drug made tumours disappear completely in 79% of patients!
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Another Cancer-Independent Targeted Drug Approved! Up To 84% Efficacy!
Targeted drug Selpercatinib has received accelerated approval from the FDA. It is cancer-independent and may benefit any solid tumour with a positive RET gene fusion. It is up to 84% effective in selected patients with non-small cell lung cancer!
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FDA Grants Orphan Drug Status To Two New Therapies In a Row, And These Two Groups Of Patients Are Expected To Benefit!
Recently, the US FDA has granted orphan drug status to two new therapeutics in a row. One is a small molecule inhibitor, PCLX-001, for the treatment of acute myeloid leukaemia; the other is a T-cell therapy, ET140203, for the treatment of hepatoblastoma. Both therapies are currently in relevant trials.
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World's 2nd KRAS Inhibitor Approved For Non-Small Cell Lung Cancer With 80% Efficacy!
The FDA has granted accelerated approval to Adagrasib for the treatment of patients with KRAS G12C mutations in non-small cell lung cancer. In the trial, the drug resulted in disease control in 80% of patients, of which, 43% had substantial tumour shrinkage.
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New Targeted Drug For Leukaemia Approved, 35% Of Patients' Cancer Cells Disappear Completely!
The US FDA has approved a new leukaemia drug, Olutasidenib, which has been shown to be effective and has a controlled safety profile, resulting in the complete disappearance of cancer cells in 35% of patients enrolled, with efficacy lasting up to 25.9 months.
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New CAR-T Therapy CB-010, Granted Two FDA Designations And Three Patients Are Cancer-Free For Six Months!
According to an announcement from Caribou Biosciences, the FDA has granted advanced therapy designation in regenerative medicine for the cutting-edge CAR-T therapy CB-010 for the treatment of relapsed or refractory large B-cell lymphoma and fast track designation for the treatment of relapsed or refractory B-cell non-Hodgkin's lymphoma.
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New Treatment For Lung Cancer Approved! Significantly Better Than Chemotherapy!
The US FDA approved a new treatment for non-small cell lung cancer - Tremelimumab + Durvalumab + platinum-based chemotherapy. The triple combination therapy significantly improves efficacy and patient survival and has a good safety profile.
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Pfizer's New Treatment Elranatamab Receives FDA Breakthrough Therapy Designation For Relapsed Or Refractory Multiple Myeloma
Pfizer's new treatment, Elranatamab, has received Breakthrough Therapy designation from the FDA for the treatment of patients with relapsed or refractory multiple myeloma. Data from the trial showed a patient efficacy rate of 61.0% and that once the therapy is effective, efficacy is maintained for more than six months in over 90% of patients!