HOT & NOT

The Scottish Medicines Consortium (SMC) has recommended Cabometyx (cabozantinib) plus Opdivo (nivolumab) for use via NHS Scotland for the first-line treatment of advanced renal cell carcinoma (RCC) in adults. In a Phase III study, the risk of death for advanced RCC patients was decreased by 34% with the Cabometyx plus Opdivo combination compared to currently available therapy sunitinib. The study also hit its primary endpoint of progression-free survival (PFS).

MSD and Ridgeback Therapeutics’ investigational antiviral medicine molnupiravir reduced the risk of hospitalisation and death by approximately 50% in non-hospitalised adult patients with mild-to-moderate COVID-19. The Phase III trial interim results evaluated 775 patients, who were initially enrolled on or before August 5. The trial is now reaching its full recruitment of the Phase III trial of 1,550 participants.

The National Institute for Health and Care Excellence (NICE) has recommended Boehringer Ingelheim’s Ofev (nintedanib) for the treatment of adult patients with chronic fibrosing interstitial lung diseases with a progressive phenotype (PF-ILD). The recommendation is supported by data from the Phase III INBUILD trial, which found Ofev met the primary endpoint of significantly slowing disease progression – defined as an absolute decline in forced vital capacity (FVC) over 52 weeks.

Bristol Myers Squibb (BMS) has announced that its oral selective tyrosine kinase 2 (TYK2) inhibitor deucravacitinib did not meet the primary efficacy endpoint of clinical remission at Week 12 in patients with moderate-to-severe ulcerative colitis (UC). The investigational TYK2 inhibitor also did not hit any of the secondary efficacy endpoints. The safety profile of deucravacitinib was consistent with previously reported studies in psoriasis and psoriatic arthritis.

The National Institute for Health and Care Excellence (NICE) has provisionally decided not to recommend Janssen’s oral multiple sclerosis (MS) drug Ponvory (ponesimod) for routine use on the NHS in England and Wales for relapsing forms of MS with active disease. In response to the decision, Sarah Rawlings, director of Research and External Affairs at the MS Society said it was “disappointing to see ponesimod not recommended at this stage”.

The US Food and Drug Administration (FDA) has issued Omeros a Complete Response Letter (CRL), rejecting its investigational drug narsoplimab for the treatment of haematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA). In the CRL, the FDA ‘expressed difficulty in estimating the treatment of narsoplimab in HSCT-TMA’ and requested additional information to support approval.