HOT & NOT

Novartis’ IL-17A inhibitor Cosentyx (secukinumab) has gained an EU label update to include data for axial manifestations of psoriatic arthritis (PsA). Novartis said the move makes Cosentyx the first biologic with proven efficacy in all six key manifestations of PsA, and also the only biologic with ‘fast and lasting’ relief of axial manifestations of PsA in a dedicated study. In the Phase IIIb MAXIMISE trial, 62.9% and 66.3% of patients treated with Cosentyx 300mg and 150mg, respectively, achieved the primary endpoint of an ASAS20 response versus 31.3% of placebo.

The EMA's human medicines committee has recommended six medicines for approval: PTC Therapeutics’ Evrysdi (risdiplam) for the treatment of certain types of spinal muscular atrophy (SMA); GlaxoSmithKline’s Jemperli (dostarlimab) for certain types of recurrent or advanced endometrial cancer; BioCryst's Orladeyo (berotralstat) for the prevention of recurrent attacks of hereditary angioedema; and Mylan's bevacizumab biosimilars Abevmy and Lextemy, for the treatment various cancers.

NHS Funding for Daiichi Sankyo’s cholesterol-lowering drugs Nilemdo (bempedoic acid) and Nustendi (bempedoic acid/ezetimibe) has been endorsed by the UK's National Institute for Health and Care Excellence (NICE). The drugs have been recommended for the treatment of primary hypercholesterolaemia or mixed dyslipidaemia (heterozygous familial and non-familial), as an adjunct to diet and when statins are contraindicated or not tolerated, or when the standard treatment ezetimibe alone does not control low-density lipoprotein cholesterol (LDL-C) adequately.

Novartis' IL-1β inhibitor canakinumab has failed to hit the primary endpoint of overall survival in a Phase III non-small cell lung cancer (NSCLC) trial. The CANOPY-2 study evaluated canakinumab in combination with docetaxel chemotherapy among 237 adults with locally advanced or metastatic NSCLC, whose disease had progressed while on or after previous platinum-based chemotherapy and PD-(L)1 inhibitor immunotherapy. Despite the disappointing results, Novartis said two additional Phase III CANOPY trials will continue, in the first-line and adjuvant settings.

NICE has published final draft guidance which does not recommend MSD's Keytruda (pembrolizumab) for treating locally advanced or metastatic urothelial carcinoma in adults who have had platinum-containing chemotherapy, despite an appeal by the drugmaker to reconsider and additional evidence collected as part of the Cancer Drugs Fund (CDF). Even when offered with its agreed discount, the most plausible cost-effectiveness estimate for Keytruda in this setting remains higher than what NICE normally considers acceptable for end-of-life treatments, the Institute said.

Kyowa Kirin’s Poteligeo (mogamulizumab) has been turned down by the NICE for NHS treatment of adults living with rare blood cancers in its final appraisal document (FAD). Poteligeo is a treatment for adults living with the rare blood cancers mycosis fungoides (MF) and Sézary syndrome (SS), two subtypes of cutaneous T-cell lymphoma (CTCL), who have received at least one prior systemic therapy. According to NICE, clinical trial evidence for Poteligeo is “very uncertain” as the drug was compared with vorinostat, which is not used or licensed in the UK.