The U.S. Food and Drug Administration (FDA) has approved FoundationOne Liquid CDx, a blood test that can be used to identify cancer patients who may benefit from certain targeted therapies, including the FDA-approved prostate cancer therapy Rubraca (rucaparib). The test became commercially available on Aug. 28, and is covered by Medicare and Medicare Advantage for qualifying individuals…
The U.S. Food and Drug Administration (FDA) has accepted and given priority review to AstraZeneca‘s application requesting a new dosing regimen for Imfinzi (durvalumab) to treat certain non-small cell lung cancer (NSCLC) and bladder cancer patients. If approved, Imfinzi could be administered at a fixed dose of 1,500 mg every four weeks, an alternative to the weight-based dosing of 10…
The Canadian Cancer Trials Group (CCTG) has launched a Phase 2 study of CFI-400945 in combination with Imfinzi (durvalumab) for the treatment of advanced or metastatic triple negative breast cancer (TNBC). CFI-400945 is an investigational compound that stops cell division by inhibiting a protein called polo-like kinase 4. Because unchecked cell division is a hallmark of…
The European Commission (EC) has approved Blenrep (belantamab mafodotin), a first-in-class therapy developed by GlaxoSmithKline (GSK) for the treatment of multiple myeloma. The approval covers Blenrep as a monotherapy — that is, without other treatments — in adults who have been treated with at least four prior therapies, have demonstrated disease progression on the last therapy,…
The first two patients have been randomized in Phase 2 of the OVATION 2 trial testing the immunotherapy candidate GEN-1 in newly diagnosed advanced ovarian cancer. Celsion Corporation, the immunotherapy’s developer, expects to enroll up to 118 patients in this second part of the study by the end of 2021, and will provide clinical updates throughout the…
Tecentriq (atezolizumab) combined with chemotherapy failed to meet its primary endpoint of progression-free survival — the length of time during and after therapy in which the patient’s disease does not get worse — for the initial (first-line) treatment of PD-L1-positive individuals with metastatic triple-negative breast cancer (TNBC). These are the findings of the multicenter Phase 3…
An upcoming Phase 2 clinical trial is set to evaluate Novocure‘s Tumor Treating Fields, known as TTFields, in combination with Keytruda (pembrolizumab) for the treatment of non-small cell lung cancer (NSCLC). TTFields is a treatment method that uses electric fields tuned to specific frequencies to interrupt cancer cell division, causing cancer cells to die and…
Tolmar Pharmaceuticals maintains a complete inventory of Eligard (leuprolide acetate), its therapy for advanced prostate cancer, and had increased production in response to reports of shortages of other leuprolide acetate products in the U.S., the company announced. As of Aug. 25, the U.S. Food and Drug Administration listed three formulations of Lupron Depot (leuprolide acetate)…
The U.S. Food and Drug Administration (FDA) has approved Darzalex (daratumumab), in combination with Kyprolis (carfilzomib) and dexamethasone, to treat adults with relapsed or refractory multiple myeloma after one to three lines of therapy. Specifically, Darzalex — created by Genmab, and developed and commercialized by Janssen Pharmaceuticals — was approved in combination with two dosing regimens of Kyprolis (developed by Amgen): 70 mg/m2 once…
The European Commission has approved Novartis‘s Piqray (alpelisib) in combination with Faslodex (fulvestrant) for the treatment of advanced or metastatic breast cancer that is hormone receptor-positive and human epidermal growth factor receptor-2-negative (HR+/HER2-) and harbors a PIK3CA mutation. The approval, which follows a recent positive opinion from the European Medicine Agency’s Committee for Medicinal Products for Human…
