The European Commission granted Conditional Marketing Authorization for Bristol Myers Squibb’s Abecma (idecabtagene vicleucel; ide-cel) – a first-in-class B-cell maturation antigen-directed chimeric antigen receptor T cell immunotherapy – for the treatment of adult patients with relapsed and refractory multiple myeloma who have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 antibody and have demonstrated disease progression on the last therapy.
The U.S. Food and Drug Administration granted accelerated approval to GlaxoSmithKline’s PD-1 checkpoint inhibitor Jemperli (dostarlimab) for a wider group of indications for adults with mismatch repair-deficient (dMMR) recurrent or advanced endometrial cancer.
Swiss drugmakers Roche and Novartis each won European approval for drugs on March 30 in a sign that the rival Basel-based companies are increasingly competing for the same patients.
The European Union’s drugs regulator on March 11 approved Johnson & Johnson’s single dose Covid-19 vaccine, as the bloc seeks to speed up a stuttering inoculation campaign and boost its supplies.
AstraZeneca Plc’s cancer drug Imfinzi was approved in Europe and Britain for a spaced-out regimen in a common type of lung cancer to help reduce the frequency of hospital visits while continuing treatment.
The European Commission approved Swiss drugmaker Roche’s Xofluza to treat influenza in patients aged 12 years and older, the first new influenza antiviral for patients in almost 20 years.
The European Commission approved Aimmune Therapeutics Inc.’s Palforzia for the treatment of peanut allergy.
The U.S. Food and Drug Administration approved the expansion of Amgen’s Kyprolis (carfilzomib) U.S. prescribing information to include the product’s use in combination with Darzalex (daratumumab) plus dexamethasone (DKd) in two dosing regimens – once weekly and twice weekly – for the treatment of patients with relapsed or refractory multiple myeloma who have received one to three previous lines of therapy.
The European Commission gave conditional approval for the use of remdesivir in severe COVID-19 patients following an accelerated review process, making the antiviral the region’s first authorized therapy to treat the virus.
The European Commission approved Sprycel (dasatinib) to include the treatment of children and adolescents aged 1 year to 18 years with Philadelphia chromosome-positive CML in chronic phase.