The publication by Ian M. Thompson and colleagues in last week's New England Journal of Medicine regarding long term follow-up of patients in the NCI-sponsored Prostate Cancer Prevention Trial (PCPT) marks a good opportunity to review and reflect on the history of the trial and the past 30 years of prostate cancer medicine.
Prostate cancer is the most common solid tumor in men. It has been estimated that 60-75 percent of men will have histologic evidence of prostate cancer during their lifetime and that 2-4 percent of men will die of the disease. African American men are at a greater risk of diagnosis and death.
The European Commission approved the use of Rubraca (rucaparib) for a second indication, as monotherapy for the maintenance treatment of adults with platinum-sensitive relapsed high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) to platinum-based chemotherapy.
Following recent discussions with FDA, Bristol-Myers Squibb announced the voluntary withdrawal of the sBLA for the Opdivo and low-dose Yervoy (ipilimumab) combination for treatment of first-line advanced non-small cell lung cancer in patients with tumor mutational burden ≥10 mutations/megabase.
FDA issued the final guidance, Labeling for Human Prescription Drug and Biological Products Approved Under the Accelerated Approval Pathway, that aims to assist sponsors of drug and biological products in developing the Indications and Usage section of product labeling for products approved under the accelerated approval pathway.
FDA has granted Breakthrough Device Designation for Illumina's its pan-cancer assay.
Amgen said the European Commission has approved an expanded indication for Blincyto (blinatumomab) monotherapy to include adult patients with Philadelphia chromosome negative CD19 positive B-cell precursor acute lymphoblastic leukemia in first or second complete remission with minimal residual disease greater than or equal to 0.1 percent.
Genmab said its licensing partner, Janssen Biotech, Inc. has submitted the first part of a regulatory submission to FDA for a label expansion to include the use of daratumumab in combination with lenalidomide and dexamethasone for the treatment of patients with newly diagnosed multiple myeloma who are not candidates for high dose chemotherapy and autologous stem cell transplant.
Finasteride, a generic hormone-blocking drug, was found to reduce the risk of prostate cancer by 25 percent in the landmark Prostate Cancer Prevention Trial.
The Addario Lung Cancer Medical Institute and researchers from the Dana-Farber Cancer Institute are launching a novel nationwide study to understand why treatment resistance develops in a specific group of lung cancer patients.
