HOT & NOT

AstraZeneca and MSD's immunotherapy Lynparza (olaparib) has scored two new approvals in the EU: for the first-line maintenance treatment, alongside bevacizumab, in patients with HRD-positive advanced ovarian cancer; and for the treatment of patients with metastatic castration-resistant prostate cancer (mCRPC) with BRCA 1/2 mutations. Lynparza (olaparib) is a first-in-class PARP inhibitor and the first targeted treatment to block DNA damage response (DDR) in cells/tumours harbouring a deficiency in homologous recombination repair (HRR).

Bristol Myers Squibb’s Opdivo (nivolumab) plus Yervoy (ipilimumab) has received approval from the European Commission for the first-line treatment of adults with metastatic non-small cell lung cancer (NSCLC). The combination will be available for NSCLC patients in the EU whose tumours have no sensitising epidermal growth factor receptor (EGFR) mutation or anaplastic lymphoma kinase (ALK) translocation. It is the first dual immunotherapy-based treatment option to be approved for this disease in the EU, according to BMS.

AbbVie’s Venclyxto (venetoclax), in combination with Roche’s Gazyvaro (obinutuzumab), has been recommended by NICE for untreated chronic lymphocytic leukaemia (CLL), specifically for patients with del(17p)/TP53 mutation and those without del(17p)/TP53 mutation for whom cyclophosphamide and rituximab (FCR) or bendamustine and rituximab (BR) are unsuitable. NICE has also recommended the combination for use within the Cancer Drugs Fund for patients without del(17p)/TP53 mutation and for whom FCR or BR are suitable.

US regulators have issued a Complete Response Letter (CRL) regarding the Biologics License Application (BLA) for Sanofi's sutimlimab, an investigational monoclonal antibody for the treatment of haemolysis in adults with cold agglutinin disease. The CRL refers to certain deficiencies identified by the agency during a pre-licence inspection of a third-party facility responsible for manufacturing. There were no clinical or safety deficiencies noted in the CRL with respect to the application.

The Phase II CAVALI programme has shown that the addition of AstraZeneca's Calquence (acalabrutinib) to best supportive care in patients hospitalised with respiratory symptoms of COVID-19 failed to increase the proportion who remained alive and free of respiratory failure. No new safety signal for Calquence was observed in the trials. Calquence is a next-generation, selective inhibitor of Bruton’s tyrosine kinase (BTK). On the plus side, the drug won EU approval as a treatment for the treatment of adult patients with chronic lymphocytic leukaemia (CLL).

The Scottish Medicines Consortium has rejected Relypsa’s Veltassa (patiromer) for the treatment of hyperkalaemia, a condition which causes potassium levels to increase in the blood, leading to increased risk of cardiac arrhythmias. Lowering potassium levels for patients needing emergency care can be life-saving. The cost watchdog said it was ‘not satisfied’ by the evidence on the cost-effectiveness of the treatment. NICE turned down the drug in 2018 but subsequently reversed its decision following new evidence and a lower price.