FDA has granted an accelerated approval to afamitresgene autoleucel (Tecelra), a melanoma-associated antigen A4 (MAGE-A4)-directed genetically modified autologous T-cell immunotherapy, for adults with unresectable or metastatic synovial sarcoma who have received prior chemotherapy, are HLA-A*02:01P, -A*02:02P, -A*02:03P, or -A*02:06P positive and whose tumor expresses the MAGE-A4 antigen as determined by FDA-approved or cleared companion diagnostic devices.
FDA has approved Darzalex Faspro (daratumumab and hyaluronidase-fihj) in combination with bortezomib, lenalidomid, and dexamethasone (D-VRd) for induction and consolidation in patients with newly-diagnosed multiple myeloma who are eligible for an autologous stem cell transplant.
Guardant Health Inc., a precision oncology company, announced that FDA has approved the company’s Shield blood test for colorectal cancer screening in adults age 45 and older who are at average risk for the disease.
FDA has approved Jemperli (dostarlimab-gxly) in combination with carboplatin and paclitaxel (chemotherapy) followed by Jemperli as a single agent for the treatment of adult patients with primary advanced or recurrent endometrial cancer.
FDA has granted Priority Review status to Scemblix (asciminib) for treatment of newly-diagnosed adult patients with Philadelphia chromosome-positive CML in chronic phase.
The European Medicines Agency’s Committee for Medicinal Products for Human Use adopted a positive opinion recommending approval of Keytruda in combination with Padcev (enfortumab vedotin-ejfv), an antibody-drug conjugate, for the first-line treatment of adult patients with unresectable or metastatic urothelial carcinoma.
The European Medicines Agency’s Committee for Medicinal Products for Human Use of the European Medicines Agency adopted a positive opinion of zolbetuximab, recommending the approval of it in the European Union.
Telix opened an expanded access program in the United States for TLX101-CDx (Pixclara, 18F-floretyrosine or 18F-FET) an investigational positron emission tomography agent for imaging progressive or recurrent glioma, following FDA agreement to proceed.
Labcorp announced an expanded collaboration with Ultima Genomics to utilize its UG 100TM sequencing solution and ppmSeqTM technology to explore new whole genome sequencing clinical applications, including molecular residual disease in patients with early-stage solid tumor cancers.
FDA has accepted the filing of Telix Pharmaceuticals Limited’s New Drug Application for TLX007-CDx, a new and proprietary cold kit for the preparation of PSMA-PET imaging for prostate cancer.
