The FDA granted accelerated approval to Tivdak (tisotumab vedotin-tftv), a tissue factor-directed antibody and microtubule inhibitor conjugate, for adult patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy.
The FDA authorized the marketing of Paige Prostate, a software program which assists pathologists in the detection of areas that are suspicious for cancer as an adjunct to the review of digitally-scanned slide images from prostate biopsies.
The FDA granted Fast Track designation to CT-0508, a human epidermal growth factor receptor 2 targeted chimeric antigen receptor macrophage for the treatment of patients with solid tumors.
The Committee for Medicinal Products for Human Use of the European Medicines Agency recommended approval of Opdivo (nivolumab) in combination with fluoropyrimidine and platinum-containing chemotherapy for the first-line treatment of adult patients with HER2-negative advanced or metastatic gastric, gastroesophageal junction, or esophageal adenocarcinoma whose tumors express PD-L1 with a combined positive score ≥ 5.
The Committee for Medicinal Products for Human Use of the European Medicines Agency recommended approval of Keytruda (pembrolizumab), an anti-PD-1 therapy, in combination with chemotherapy for the treatment of locally recurrent unresectable or metastatic triple-negative breast cancer in adults whose tumors express PD-L1 (Combined Positive Score ≥10) and who have not received prior chemotherapy for metastatic disease.
Exkivity (mobocertinib) was granted FDA accelerated approval for adult patients with locally advanced or metastatic non-small cell lung cancer with epidermal growth factor receptor exon 20 insertion mutations, as detected by an FDA-approved test, whose disease has progressed on or after platinum-based chemotherapy.
FDA has granted an orphan drug designation to the active ingredient hypericin (HyBryte) for the treatment of T-cell lymphoma, extending the target population beyond cutaneous T-cell lymphoma as previously granted.
Science 37, Foundation Medicine collaborate on interventional home-based clinical trials in oncology
Science 37 and Foundation Medicine are collaborating to enable decentralized clinical research in oncology that will optimize recruitment and enrollment, improve patient retention, and expand access to precision cancer care.
FDA issued a safety communication Aug. 20 that included new recommendations for IRBs and investigators studying robotically-assisted surgical devices for use in mastectomy procedures or in the prevention or treatment of breast cancer.
Genentech has withdrawn the U.S. accelerated approval indication for Tecentriq (atezolizumab) in combination with chemotherapy (Abraxane, albumin-bound paclitaxel; nab-paclitaxel) for the treatment of adults with unresectable locally advanced or metastatic triple-negative breast cancer whose tumors express PD-L1, as determined by an FDA)-approved test.
