Here is an update on the FDA effort to cull the backlog of what the agency has colorfully dubbed the “dangling indications” of cancer drugs: two indications taken off the market by sponsors; one facing an uncertain future.
Fifty-four organizations involved in health care sent a letter to the Senate leadership, urging confirmation of Robert Califf as FDA commissioner.
FDA has approved Fyarro for injectable suspension (albumin-bound) for adult patients with locally advanced unresectable or metastatic malignant perivascular epithelioid cell tumor (PEComa).
FDA has approved Darzalex Faspro (daratumumab + hyaluronidase-fihj) and Kyprolis (carfilzomib) plus dexamethasone for adult patients with relapsed or refractory multiple myeloma who have received one to three prior lines of therapy.
FDA has approved Cytalux (pafolacianine), an optical imaging agent, for adult patients with ovarian cancer as an adjunct for interoperative identification of malignant lesions.
FDA has granted orphan drug designation to Ultimovacs ASA’s universal cancer vaccine UV1 for the treatment of stage IIB-IV melanoma.
Emergent public-private partnerships (PPPs) have risen to the occasion to streamline and coordinate severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccines. With these monumental efforts have come important public discussions about equitable access and representation in clinical trials (CTs).
FDA approved the anti-PD-1 therapy Keytruda (pembrolizumab) for the adjuvant treatment of patients with renal cell carcinoma at intermediate-high or high risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions.
Mark McLaughlin—a researcher with the West Virginia University Cancer Institute and Modulation Therapeutics Inc.—and his colleagues have received FDA approval to begin human trials of a new drug called MTI-201, which treats uveal melanoma after the cancer has traveled to another part of the body.
FDA watchers and clinical trialists in oncology may want to pay close attention to the agency’s latest plans to increase representation of traditionally marginalized populations in drug development.
