HOT & NOT

GSK has bagged a nod in Europe for Blenrep (belantamab mafodotin-blmf) to treat relapsed or refractory multiple myeloma (MM). Blenrep is a first-line inhibitor of BCMA, a cell-surface protein that plays a crucial role in the survival of plasma cells and is expressed on MM cells. In the DREAMM-2 study treatment with the drug resulted in an overall response rate of 32%; median duration of response was 11 months and median overall survival was 13.7 months.

The EU Commission has granted conditional approval for use of Hansa Biopharma's Idefirix (imlifidase) to desensitise kidney transplant patients with a highly sensitised immune system. The approval covers the drug's use for adult kidney transplant patients with a positive crossmatch against an available deceased donor. Idefirix is an immunosuppressant that reduces the level of donor specific antibodies, thus enabling transplantation.

AstraZeneca's Tagrisso (osimertinib) has been recommended for use within NHS England, in line with its licensed indication, for adults with untreated locally advanced or metastatic epidermal growth factor receptor (EGFR) mutation-positive non-small cell lung cancer (NSCLC). In clinical trials, the drug was shown to provide an overall survival benefit of more than three years when used as a first-line treatment compared to first-generation medicines in the same class.

Janssen is disappointed with second draft guidance from NICE rejecting its nasal depression spray Spravato (esketamine) for NHS use. Following a second appraisal consultation, the Institute is not recommending use of the spray, in combination with an SSRI or SNRI, for adults with treatment-resistant major depressive disorder (MDD) who have not responded to at least two different treatments with antidepressants in the current moderate to severe depressive episode.

Sanofi and Regeneron's rheumatoid arthritis drug Kevzara (sarilumab) has failed to hit targets in a late-stage trial involving patients hospitalised with COVID-19, signalling the end of its development in this area. The trial assessing intravenously administered Kevzara at a dose of 200mg or 400mg in severely or critically ill patients hospitalised with COVID-19 did not meet its primary endpoint and key secondary endpoint when Kevzara was compared to placebo.

In preliminary guidelines, NICE has turned down NHS funding for Pierre Fabre's Braftovi (encorafinib) in combination with cetuxiab as a treatment for BRAF V600E mutation-positive metastatic colorectal cancer in adults who have had previous systemic treatment. The combination's cost-effectiveness is uncertain, partly because it was not directly compared with therapies used in NHS clinical practice, the Institute noted.