Asciminib: First Approval.

Asciminib (Scemblix) is an orally administered, small molecule, selective allosteric inhibitor that targets the myristoyl pocket of the BCR-ABL1 tyrosine kinase and is being developed by Novartis for the treatment of haematological malignancies, including Philadelphia chromosome-positive (Ph+) chronic myeloid leukaemia (CML). The drug is active against a number of the single catalytic-site mutations, such as T315I, that confer resistance to conventional tyrosine kinase inhibitors (TKIs) that bind to the ATP-binding site of BCR-ABL1. In October 2021, asciminib monotherapy was granted accelerated approval for the treatment of adults with Ph+ CML in chronic phase (CML-CP), previously treated with ≥ 2 TKIs, and full approval for the treatment of adults with Ph+ CML-CP with the T315I mutation.

Chiglitazar: First Approval.

Chiglitazar (Bilessglu) is an orally administered, non-thiazolidinedione small-molecule agonist of α, δ and γ peroxisome proliferator-activated receptors (PPARs) being developed by Chipscreen Biosciences for the treatment of type 2 diabetes (T2D) and non-alcoholic steatohepatitis. In October 2021, chiglitazar was approved in China for use as an adjunct to diet and exercise to improve glycaemic control in adult patients with T2D. The drug is also in phase 2 clinical development in China for the treatment of non-alcoholic steatohepatitis.

Atogepant: First Approval.

Atogepant (Qulipta™) is an orally administered, small-molecule, calcitonin gene-related peptide (CGRP) receptor antagonist being developed by AbbVie for the prophylaxis of migraine. In September 2021, atogepant was approved in the USA for the preventive treatment of episodic migraine in adults. The drug is also in phase 3 clinical development for the preventive treatment of migraine in various other countries.

Abrocitinib: First Approval.

Abrocitinib (Cibinqo) is an oral small-molecule inhibitor of Janus kinase 1 (JAK1) being developed by Pfizer for the treatment of moderate-to-severe atopic dermatitis (AD). In September 2021, abrocitinib was approved in the UK and Japan for the treatment of moderate-to-severe AD in adults and adolescents 12 years and older who are candidates for systemic therapy. Abrocitinib has also received a positive CHMP opinion in the EU for the treatment of moderate-to-severe atopic dermatitis in adults who are candidates for systemic therapy.

Casirivimab/Imdevimab: First Approval.

Casirivimab/imdevimab (Ronapreve™; REGEN-COV™) is a co-packaged combination of two neutralizing immunoglobulin gamma 1 (IgG1) human monoclonal antibodies (casirivimab and imdevimab) against the spike protein of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the causative agent of coronavirus disease 2019 (COVID-19). Casirivimab/imdevimab received its first emergency use authorization for the treatment of COVID-19 in November 2020 in the USA, with similar authorizations subsequently granted in various other countries, including India, Canada, and Switzerland. In February 2021, casirivimab/imdevimab was granted a positive scientific opinion in the EU for the treatment of COVID-19.

Disitamab Vedotin: First Approval.

Disitamab vedotin (Aidixi) is an antibody-drug conjugate comprising a monoclonal antibody against human epidermal growth factor receptor 2 (HER2) conjugated via a cleavable linker to the cytotoxic agent monomethyl auristatin E. Disitamab vedotin is being developed by RemeGen for the treatment of solid tumours, including gastric cancer; Seagen has the right to develop disitamab vedotin globally outside of RemeGen's territory. In June 2021, disitamab vedotin received its first Biologics License Application (BLA) approval in China for the treatment of patients with HER2-overexpressing (defined as IHC2+ or 3+) locally advanced or metastatic gastric cancer (including gastroesophageal junction adenocarcinoma) who have received at least two systemic chemotherapy regimens.

Belzutifan: First Approval.

Belzutifan (Welireg™) is an oral small molecule inhibitor of hypoxia-inducible factor (HIF)-2α being developed by Peloton Therapeutics for the treatment of solid tumours, including renal cell carcinoma (RCC) with clear cell histology (ccRCC) and von Hippel-Lindau (VHL) disease-associated RCC. In August 2021, belzutifan received its first approval in the USA for the treatment of patients with VHL disease who require therapy for associated RCC, central nervous system (CNS) haemangioblastomas or pancreatic neuroendocrine tumours (pNET), not requiring immediate surgery. Clinical studies of belzutifan (as monotherapy or combination therapy) in other indications, including ccRCC, pNET and phaeochromocytoma/paraganglioma, are also underway in various countries.

Anifrolumab: First Approval.

Anifrolumab (anifrolumab-fnia; Saphnelo) is a monoclonal antibody antagonist of the type 1 interferon receptor (IFNAR). It is being developed by AstraZeneca (under license from Medarex, now Bristol-Myers Squibb) for the treatment of autoimmune disorders, including systemic lupus erythematosus (SLE) and lupus nephritis, the underlying pathogenesis of which involves type 1 interferon. In July 2021, intravenous anifrolumab was approved in the USA for the treatment of adult patients with moderate to severe SLE who are receiving standard therapy.

Furmonertinib: First Approval.

Furmonertinib mesylate (hereafter furmonertinib) [Ivesa] is a selective epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) being developed by Allist Pharmaceuticals for the treatment of patients with EGFR mutation-positive non-small cell lung cancer (NSCLC). In March 2021, furmonertinib received its first approval in China for the treatment of patients with locally advanced or metastatic NSCLC with confirmed EGFR T790M mutation whose disease has progressed during or after EGFR TKI therapy. Furmonertinib (as monotherapy and/or combination therapy) continues to be assessed in phase I/II and phase III trials for NSCLC with EGFR mutation in China, and its clinical development is also underway/planned in China and elsewhere for NSCLC with various EGFR mutations.

Odevixibat: First Approval.

Odevixibat (Bylvay™) is a small molecule inhibitor of the ileal bile acid transporter being developed by Albireo Pharma, Inc. for the treatment of various cholestatic diseases, including progressive familial intrahepatic cholestasis (PFIC). In July 2021, odevixibat received its first approval in the EU for the treatment of PFIC in patients aged ≥ 6 months, followed shortly by its approval in the USA for the treatment of pruritus in patients aged ≥ 3 months with PFIC.

Correction to: Cemiplimab: A Review in Advanced Cutaneous Squamous Cell Carcinoma.

The title for the dosage on line 3, which previously read.

Cemiplimab: A Review in Advanced Cutaneous Squamous Cell Carcinoma.

Cemiplimab (Libtayo) is an antibody immunotherapy that stimulates an anti-cancer response via programmed cell death protein-1 (PD-1) blockade. It is the first approved treatment in the USA and EU for patients with locally advanced (laCSCC) or metastatic (mCSCC) cutaneous squamous cell carcinoma who are not candidates for curative surgery or curative radiotherapy. Approval was based largely on positive results from the phase II EMPOWER-CSCC 1 trial in this patient population.

Cenegermin: A Review in Neurotrophic Keratitis.

Cenegermin (Oxervate™), an ophthalmic solution containing 20 µg/mL of recombinant human nerve growth factor (rhNGF), is the first drug to be approved for the treatment of neurotrophic keratitis (NK; also referred to as neurotrophic keratopathy). In the registration trials, the majority of adults with moderate or severe NK experienced complete corneal healing after up to 8 weeks of topical cenegermin therapy. The rate of complete corneal healing was generally higher, and that of disease progression was lower, with cenegermin than with vehicle.

Apremilast: A Review in Oral Ulcers of Behçet's Disease.

The oral phosphodiesterase 4 inhibitor apremilast (Otezla) is indicated for the treatment of oral ulcers associated with Behçet's disease in some countries, including the USA (where it is the first agent approved for the disease) and Japan. In phase 2 and 3 trials in adults with this chronic and debilitating disorder, 12 weeks of treatment with apremilast 30 mg twice daily reduced the number and pain of oral ulcers and disease activity relative to placebo, with these clinical benefits being accompanied by improvements in health-related quality of life (HR-QOL). Benefits of apremilast were seen regardless of baseline patient/disease characteristics and in Japanese patients, and were sustained over up to 64 weeks of treatment.

Dupilumab: A Review in Moderate to Severe Asthma.

Dupilumab (Dupixent) is a fully human monoclonal antibody against the interleukin (IL)-4 receptor α subunit of IL-4 and IL-4/IL-13 receptor complexes. IL-4 and IL-13 are key cytokines in driving type 2 inflammation, a dominant and largely eosinophilic inflammatory pathway in asthma. Trials evaluating the efficacy of dupilumab in asthma include three pivotal, placebo-controlled, phase 3 or 2b trials of 24-52 weeks' treatment duration in patients aged ≥ 12 years with moderate-to-severe asthma (inadequately controlled with medium-to-high dose inhaled corticosteroids) or severe asthma [dependent on oral corticosteroids (OCS) for control].

CTCF-dependent chromatin boundaries formed by asymmetric nucleosome arrays with decreased linker length.

The CCCTC-binding factor (CTCF) organises the genome in 3D through DNA loops and in 1D by setting boundaries isolating different chromatin states, but these processes are not well understood. Here we investigate chromatin boundaries in mouse embryonic stem cells, defined by the regions with decreased Nucleosome Repeat Length (NRL) for ∼20 nucleosomes near CTCF sites, affecting up to 10% of the genome. We found that the nucleosome-depleted region (NDR) near CTCF is asymmetrically located >40 nucleotides 5'-upstream from the centre of CTCF motif.

Correction to: Polatuzumab Vedotin: First Global Approval.

The article Polatuzumab Vedotin: First Global Approval, written by Emma D. Deeks, was originally published Online First without Open Access. After publication in volume 79, issue 13, pages 1467-1475 Roche/GCC requested that the article be Open Choice to make the article an open access publication.

Correction to: Trifluridine/Tipiracil: A Review in Metastatic Gastric Cancer.

The article Trifluridine/Tipiracil: A Review in Metastatic Gastric Cancer, written by Connie Kang, Sohita Dhillon and Emma D. Deeks, was originally published Online First without open access.

Trifluridine/Tipiracil: A Review in Metastatic Gastric Cancer.

Trifluridine/tipiracil (Lonsurf) is a fixed-dose combination tablet comprising trifluridine, an antineoplastic nucleoside analogue, and tipiracil, a thymidine phosphorylase inhibitor. Trifluridine/tipiracil has recently been granted an additional indication in the USA for the treatment of metastatic gastric cancer, including gastroesophageal junction adenocarcinoma, in patients who have been previously treated with at least two systemic treatment regimens, and has received a positive opinion for this indication in the EU. In the large pivotal phase III TAGS trial, trifluridine/tipiracil plus best supportive care (BSC) significantly prolonged overall survival (OS; primary endpoint) compared with placebo plus BSC in this patient group.

Tropicamide/Phenylephrine/Lidocaine Intracameral Injection: A Review in Cataract Surgery.

Tropicamide 0.02%/phenylephrine 0.31%/lidocaine 1% injectable solution (Mydrane) is the first fixed-dose mydriatic/anaesthetic combination approved for intracameral use in adults undergoing cataract surgery.

Correction to: Damoctocog Alfa Pegol: A Review in Haemophilia A.

The article Damoctocog Alfa Pegol: A Review in Haemophilia A, written by Julia Paik and Emma D. Deeks, was originally published Online First without open access.