FDA approved FoundationOne CDx to be used as a companion diagnostic for two groups of current and future FDA-approved therapeutics in melanoma, including BRAF inhibitor monotherapies targeting BRAFV600E and BRAF/MEK inhibitor combination therapies targeting BRAFV600E or V600K mutations.
FDA has approved Cytalux, a fluorescent imaging agent that binds to cancer cells and allows physicians to identify cancerous lesions during ovarian cancer surgery.
FDA has granted premarket approval to Thermo Fisher Scientific’s Oncomine Dx Target Test as a companion diagnostic to help identify non-small cell lung cancer patients whose tumors carry epidermal growth factor receptor Exon20-insertion mutations for potential treatment with Rybrevant (amivantamab-vmjw), Janssen Biotech Inc.’s targeted therapy.
FDA has accepted for priority review the supplemental Biologics License Application for Reblozyl (luspatercept-aamt), a first-in-class erythroid maturation agent, for the treatment of anemia in adults with non-transfusion dependent beta thalassemia.
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.
