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 granted Priority Review status to Scemblix (asciminib) for treatment of newly-diagnosed adult patients with Philadelphia chromosome-positive CML in chronic phase.
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.
The FDA Oncologic Drugs Advisory Committee July 25 voted unanimously to set more rigorous standards for new trials for approval of perioperative indications of cancer drugs.
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.
FDA cleared the investigational new drug application for ZW191, a novel folate receptor-α targeted topoisomerase I inhibitor antibody-drug conjugate sponsored by Zymeworks.
More than a year after a catastrophic shortage of platinum-based chemotherapy drugs swept through the U.S., FDA on June 28 officially removed carboplatin and cisplatin from the drug shortage list.
FDA granted Fast Track designation for 225Ac-FL-020, a radiopharmaceutical which targets prostate-specific membrane antigen for the treatment of metastatic castration-resistant prostate cancer.
