FDA approved a supplemental New Drug Application to update the U.S. Prescribing Information for Tibsovo, an isocitrate dehydrogenase-1 inhibitor, to include adult patients with newly diagnosed acute myeloid leukemia with a susceptible IDH1 mutation as detected by an FDA-approved test who are ≥ 75 years old or who have comorbidities that preclude use of intensive induction chemotherapy.
The Committee for Medicinal Products for Human Use of the European Medicines Agency adopted a positive opinion recommending Talzenna (talazoparib), an oral poly polymerase inhibitor.
The European Medicines Agency's Committee for Medicinal Products for Human Use has adopted a positive opinion for the marketing authorization of Libtayo (cemiplimab).
The Committee for Medicinal Products for Human Use of the European Medicines Agency has adopted a positive opinion, recommending Lynparza (olaparib) as a first-line maintenance treatment of BRCA-mutated advanced ovarian cancer.
The Committee for Medicinal Products for Human Use adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Grasustek, intended for prophylaxis against neutropenia in adult patients treated with cytotoxic chemotherapy. The applicant for this medicinal product is Juta Pharma GmbH.
The Janssen Pharmaceutical Companies of Johnson & Johnson announced the submission of a supplemental New Drug Application to FDA seeking approval of a new indication for Erleada (apalutamide) for the treatment of patients with metastatic castration-sensitive prostate cancer.
Caris Life Sciences said the company has been selected by the Hoosier Cancer Research Network and the study's sponsor investigator, Matthew Galsky, to perform genomic tumor profiling for a new phase II bladder cancer clinical trial, HCRN GU16-257. This marks the second tumor profiling study Caris has been selected to lead within the Hoosier Cancer Research Network.
FDA approved pembrolizumab plus axitinib (Keytruda) for the first-line treatment of patients with advanced renal cell carcinoma.
Janssen Pharmaceuticals said Balversa (erdafitinib) received accelerated approval from FDA for the treatment of adults with locally advanced or metastatic urothelial carcinoma which has susceptible fibroblast growth factor receptor 3 or FGFR2 genetic alterations and who have progressed during or following at least one line of prior platinum-containing chemotherapy, including within 12 months of neoadjuvant or adjuvant platinum-containing chemotherapy.
FDA has approved pembrolizumab (Keytruda) for the first-line treatment of patients with stage III non-small cell lung cancer who are not candidates for surgical resection or definitive chemoradiation or metastatic NSCLC. Patients' tumors must have no EGFR or ALK genomic aberrations and express PD-L1 (Tumor Proportion Score ≥1%) determined by an FDA-approved test.
