FDA Approves New Therapies from Lilly, Novartis, Merck, J&J, and AstraZeneca
核心洞察
Eli Lilly's Ebglyss secured FDA approval for treating moderate-to-severe atopic dermatitis (搜索) in adults and children, offering significant skin clearance and itch relief.
Novartis' Kisqali gained approval for adjuvant treatment of early breast cancer (搜索), reducing recurrence risk by 28.5% when combined with an aromatase inhibitor.
Merck (搜索)'s Keytruda, combined with chemotherapy, received FDA approval for first-line treatment of unresectable advanced or metastatic malignant pleural mesothelioma (搜索) (MPM).
The U.S. Food and Drug Administration (FDA) has recently approved several new therapies and expanded the use of existing drugs from major pharmaceutical companies, marking significant advancements in the treatment of various diseases including eczema, breast cancer (搜索), lung cancer, and mesothelioma. These approvals highlight ongoing efforts to address unmet medical needs and improve patient outcomes.
Lilly's Ebglyss Approved for Atopic Dermatitis
Eli Lilly's Ebglyss (lebrikizumab) has received FDA approval for the treatment of moderate-to-severe atopic dermatitis (搜索) (eczema) in adults and children aged 12 years and older whose condition is not adequately controlled with topical prescription medications. The approval was based on data from the ADvocate 1, ADvocate 2, and ADhere studies, which demonstrated significant skin clearance as early as four weeks and meaningful itch relief as early as two weeks in patients treated with Ebglyss.
Novartis' Kisqali Approved for Early Breast Cancer
Novartis' Kisqali (ribociclib) has been approved by the FDA for the adjuvant treatment of patients with stage II and III HR+/HER2- early breast cancer (搜索) who are at risk of recurrence. This includes patients diagnosed with high-risk, node-negative disease. The approval is based on the Phase III NATALEE study, which showed that Kisqali, when added to endocrine therapy (ET), reduced the risk of recurrence by 28.5% compared to ET alone. This invasive disease-free survival benefit was consistent across all patient subgroups.
Merck's Keytruda Approved for Malignant Pleural Mesothelioma
Merck (搜索)'s Keytruda (pembrolizumab), a PD-L1 inhibitor, has received FDA approval in combination with chemotherapy for the first-line treatment of patients with unresectable advanced or metastatic malignant pleural mesothelioma (搜索) (MPM). This approval, based on data from the Phase II/III KEYNOTE-483 study, marks the first indication for Keytruda in MPM, a cancer that develops in the tissue lining the lungs.
J&J's Rybrevant Approved for Expanded Use in Advanced NSCLC
Johnson & Johnson (J&J (搜索)) announced that the FDA has approved the expanded use of Rybrevant (amivantamab) in combination with standard-of-care chemotherapy (carboplatin and pemetrexed) for the treatment of adult patients with advanced non-small cell lung cancer (搜索) (NSCLC) with EGFR (搜索) exon 19 deletions whose disease has progressed on or after treatment with an EGFR tyrosine kinase inhibitor (TKI). The approval is based on data from the MARIPOSA-2 study. Rybrevant is also approved as monotherapy for NSCLC with EGFR exon 20 insertion mutations and in combination with Lazcluze (lazertinib) for first-line treatment of NSCLC with EGFR exon 19 deletions or L858R substitution mutations.
AstraZeneca's Fasenra Approved for Eosinophilic Granulomatosis with Polyangiitis
AstraZeneca’s asthma drug Fasenra (benralizumab) has been approved for Eosinophilic Granulomatosis with Polyangiitis (搜索) (EGPA), a rare autoimmune disease that can cause damage to multiple organs and tissues. The approval is based on data from the phase III MANDARA study, which compared a single monthly injection of Fasenra to three injections per month of GSK’s Nucala (mepolizumab).