✦ Merck & Co., Inc. will voluntarily withdraw the accelerated approval indication for Keytruda (pembrolizumab) for the treatment of people with recurrent locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma whose tumors express programmed death-ligand 1 (PD-L1), as determined by an FDA-approved test, with disease progression on or after at least two lines of therapy including fluoropyrimidine- and platinum-containing chemotherapy and, if appropriate, human epidermal growth factor receptor 2 (HER2)/neu-targeted therapy. The move follows the April 29 Oncologic Drugs Advisory Committee meeting in which members voted against keeping the indication after late-stage confirmatory trials did not show clinical benefit. Merck says it will begin the withdrawal in six months.
✦ The expected average cost of new FDA-approved specialty drugs in 2020 was just under $350,000 per year. That was one of the findings of analytics company AMS’s 2020 Specialty Drug Trends Report, based on drugs added to the firm’s PredictRx module, which incorporates pertinent clinical information and AMS Cost Projection (ACP) pricing. It also found that the average yearly cost for newly approved orphan drugs was $449,507, compared with $144,130 for traditional drugs.