A cell-based gene therapy for multiple myeloma has been recommended by the European Medicines Agency for patients with multiple myeloma, an incurable blood cancer that causes plasma cells to grow out of control. Symptoms can include bone fracture or even kidney failure. The drug, Carvykti (ciltacabtagene autoleucel), is a chimeric antigen receptor (CAR) T cell medicine consisting of a patient’s own immune cells which have been engineered to target and kill cancer cells.
The US Food and Drug Administration has approved the first monoclonal antibody targeting the LAG-3 protein on T cells – one of several proteins that prevent the immune system from fighting cancer. The antibody, relatlimab, has been developed in combination with nivolumab to treat metastatic melanoma. The combination is being commercialised by Bristol Myers Squibb Co under the name Opdualag.
Valneva SE is preparing a regulatory submission in the US for its candidate vaccine, VLA1553, to prevent chikungunya virus infection. This follows positive clinical data from a six-month study which confirmed the results of a large Phase 3 trial of 4,115 adults.
The European Medicines Agency is studying the T cell immune response generated by the currently approved Covid-19 vaccines to find out whether anything can be learned for the future. In a briefing with journalists on 3 March, Marco Cavaleri, head of biological health threats and vaccines strategy, said the review covers all platforms represented by the currently approved vaccines. One of the objectives is to find out if the T cell component of immunity can offer protection against new variants of the virus.
The diabetes and cardiovascular medicine Jardiance (empagliflozin) has been approved in the US to treat a wider range of patients with heart failure, giving it a new role in reducing the risk of cardiovascular death and hospitalisation in adults. Jardiance is already approved as a supplement to diet and exercise to improve glucose control in adults with Type 2 diabetes, and to reduce the risk of cardiovascular death in adults with diabetes and cardiovascular disease.
A new medicine for uveal melanoma, a rare cancer of the eye, has received a positive opinion from the European Medicines Agency, putting it on course to be the first T cell receptor (TCR) therapy on the market in Europe. Kimmtrak (tebentafusp) is a bispecific protein comprised of a T cell receptor fused to an effector molecule that redirects T cells to cancer cells. The sponsor is Immunocore Holdings Plc which is developing TCR bispecific therapies for cancer as well as for autoimmune and infectious diseases.
The European Medicines Agency has proposed to extend the use of two messenger RNA (mRNA) vaccines for Covid-19 in order to give protection against the SARS-CoV-2 virus to younger people. In separate decisions, the agency is recommending that primary vaccination with Spikevax be approved for use in children from the ages of six to 11 years. Spikevax was developed by Moderna Inc. The agency is also proposing that Comirnaty, developed by BioNTech SE and Pfizer Inc, be authorised as a booster dose for adolescents from 12 years of age.
The US Senate has confirmed President Joe Biden’s nomination of Robert Califf to be head of the Food and Drug Administration – a position he held during the final year of the Obama administration. The vote was 50 to 46, the narrowest margin of any confirmed FDA commissioner.
The US Food and Drug Administration has approved the first bispecific antibody medicine for the eye – a treatment that targets two pathways thought to contribute to vision loss by destabilising blood vessels. The drug, Vabysmo (faricimab-svoa), has been authorised for the treatment of neovascular or ‘wet’ age-related macular degeneration (AMD) and diabetic macular oedema. Both diseases impair central vision, with the latter affecting people with Type 1 and Type 2 diabetes.
The cell-based gene therapy Breyanzi (lisocabtagene maraleucel) has received a positive opinion from the European Medicines Agency to treat patients with relapsed or refractory large B-cell lymphoma. Breyanzi was approved for the same indication in the US in 2021. It will be available to patients in the EU once the European Commission issues a marketing authorisation.