FDA approved Jaypirca (pirtobrutinib) for the treatment of adult patients with chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) who have received at least two prior lines of therapy, including a Bruton’s tyrosine kinase (BTK) inhibitor and a BCL-2 inhibitor.
FDA granted Fast Track Designation for Alpha1H for the treatment of non-muscle invasive bladder cancer. Alpha1H is sponsored by Hamlet BioPharma AB.
FDA approved Xtandi (enzalutamide) for non-metastatic castration-sensitive prostate cancer with biochemical recurrence at high risk for metastasis.
FDA has granted Breakthrough Therapy Designation to epcoritamab-bysp, an investigational T-cell engaging bispecific antibody administered subcutaneously, for relapsed or refractory follicular lymphoma.
FDA approved Keytruda (pembrolizumab) with fluoropyrimidine- and platinum-containing chemotherapy for the first-line treatment of adults with locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction adenocarcinoma.
FDA approved Augtyro (repotrectinib) for locally advanced or metastatic ROS1-positive non-small cell lung cancer.
FDA approved Truqap (capivasertib) with fulvestrant for adult patients with hormone receptor-positive, human epidermal growth factor receptor-negative locally advanced or metastatic breast cancer with one or more PIK3CA/AKT1/PTEN-alterations, as detected by an FDA-approved test, following progression on at least one endocrine-based regimen in the metastatic setting or recurrence on or within 12 months of completing adjuvant therapy.
FDA has granted approval for the HistoSonics’ Edison histotripsy device to treat liver tumors.
The European Medicines Agency’s Committee for Medicinal Products for Human Use has adopted a positive opinion recommending approval of Keytruda (pembrolizumab) in combination with gemcitabine and cisplatin, for the first-line treatment of adult patients with locally advanced unresectable or metastatic biliary tract carcinoma.
Legend Biotech Ireland Limited, a wholly owned subsidiary of Legend Biotech, has entered into an exclusive, global license agreement with Novartis Pharma AG for certain Legend Biotech chimeric antigen receptor T-cell therapies targeting DLL3, including its autologous CAR-T cell therapy candidate, LB2102 (NCT05680922).
