HOT & NOT

ViiV Healthcare’s Rukobia (fostemsavir) has received a marketing authorisation in Europe for the treatment of adults with multidrug-resistant HIV-1 infection. The EU has cleared use of the drug in patients who cannot otherwise receive a suppressive antiviral-regimen. Rukobia – a first-in-class HIV attachment inhibitor – is designed to target the first step of the HIV life-cycle. According to ViiV, it shows no cross-resistance to other currently approved antiretroviral classes, offering a new option for patients who are multidrug-resistant and at a higher risk of disease progression or death.

The European Commission (EC) has approved Seagen International's HER2 tyrosine kinase inhibitor (TKI) Tukysa (tucatinib) for the treatment of HER2-positive locally advanced or metastatic breast cancer. Its use is cleared in combination with trastuzumab and capecitabine for the treatment of adults with advanced HER2-positive breast cancer who have received at least two prior anti-HER2 treatments. In clinical trials, patients who received the TKI in combination with trastuzumab and capecitabine had a 46% reduction in the risk of cancer progression or death.

The EC has cleared used of Celltrion Healthcare’s adalimumab biosimilar Yuflyma across all 13 indications of its reference drug, including rheumatoid arthritis, ulcerative colitis and psoriasis. The marketing authorisation is based on analytical, preclinical and clinical studies which demonstrated that Yuflyma is comparable to the reference product adalimumab (AbbVie's Humira), including in terms of efficacy and safety. Yuflyma is the first adalimumab biosimilar approved in the EU with a high concentration, low-volume and citrate-free formulation, Celltrion noted.

Gilead and Galapagos are discontinuing Phase III trials of their experimental idiopathic pulmonary fibrosis drug ziritaxestat, based on recommendations of the Independent Data Monitoring Committee (IDMC). Following a regular review of unblinded data, the IDMC concluded that the drug's benefit-risk profile no longer supported continuing these studies. “We are very disappointed not to be able to bring a novel medication to patients suffering from such a devastating disease with high unmet need,” said Galapagos' chief medical officer Dr Walid Abi-Saab.

NICE has rejected Eli Lilly’s Verzenios (abemaciclib) with fulvestrant for hormone receptor-positive, HER2-negative advanced breast cancer in adults who have had endocrine therapy. NICE said there is uncertainty around the treatment because there is no evidence directly comparing it to standard care (exemestane plus everolimus) in this setting. The Institute also said it is unclear how long people would have treatment for and therefore how much the treatment would cost, making the cost-effectiveness of the therapy uncertain.

AZ’ Imfinzi (durvalumab) has failed to improved overall survival (OS) in patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) for the second time. An update on the KESTREL Phase III trial of Imfinzi found that the immunotherapy was unable to meet the primary endpoint of improving OS versus chemotherapy plus cetuximab in the first-line treatment of patients whose tumours expressed high levels of PD-L1. A combination of Imfinzi plus the CTLA-4 targeting antibody tremelimumab also failed to show an OS benefit in all-comer patients.