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.
M2GEN and Microsoft have partnered to advance data-driven solutions for the discovery, research, and development of new oncology therapies.
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.
The European Commission has approved the combination of Keytruda (pembrolizumab), Merck’s anti-PD-1 therapy, plus Lenvima (lenvatinib), a multiple receptor tyrosine kinase inhibitor discovered by Eisai, for the treatment of advanced or recurrent endometrial carcinoma in adults who have disease progression on or following prior treatment with a platinum‑containing therapy in any setting and who are not candidates for curative surgery or radiation.
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.
