May 2021 • PharmaTimes Magazine • 8-9 

// HOT OR NOT //


HOT & NOT

The European Commission (EC) has conditionally approved Incyte’s kinase inhibitor Pemazyre (pemigatinib) for advanced cholangiocarcinoma, also known as bile duct cancer. The decision allows doctors to prescribe the treatment to adults with locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 fusion or rearrangement, that have progressed after at least one prior line of systemic therapy. The approval is based on data from the FIGHT-202 study in which Pemazyre monotherapy resulted in an overall response rate of 37%.


Angelini Pharma has announced EC approval for anti-seizure drug Ontozry (cenobamate), specifically for the adjunctive treatment of focal-onset seizures with or without secondary generalisation in adults who have not been adequately controlled despite a history of treatment with at least two anti-epileptic medicines. The EC marketing authorisation is valid in all EU member states plus Iceland, Norway and Liechtenstein; the UK's Medicines and Healthcare Regulatory Agency (MHRA) is currently reviewing the submission for the drug via the reliance route.


The EC has authorised Bristol Myers Squibb’s (BMS) Opdivo (nivolumab) plus Ipsen’s Cabometyx (cabozantinib) as a first-line treatment for advanced renal cell carcinoma (aRCC). The approval is based on results from the Phase III CheckMate-9ER trial, in which the combination doubled progression-free survival in previously untreated aRCC patients versus Pfizer's tyrosine kinase inhibitor (TKI) Sutent (sunitinib) – 16.6 months versus 8.3 months, respectively. Opdivo/Cabometyx also cut the risk of death by 40% compared to the TKI inhibitor.


AstraZeneca's diabetes drug Farxiga (dapagliflozin) was unable to hit the primary endpoints in a Phase III trial assessing its potential to treat high-risk hospitalised COVID-19 patients. The drug did not hit the key target of prevention measuring organ dysfunction and all-cause mortality, as well as the primary endpoint of recovery measuring a change in clinical status at 30 days. Outside of COVID-19, Farxiga is used to improve glycaemic control in adults with type II diabetes and heart failure with reduced ejection fraction (HfrEF).


A Phase III trial of Eli Lilly and Incyte's baricitinib has failed to meet its primary endpoint in patients hospitalised with COVID-19. Baricitinib-treated patients were just 2.7% less likely than those receiving standard of care (SoC) to progress to ventilation or death by day 28, a difference that was not statistically significant. Treatment with baricitinib in addition to SoC (which included 79% receiving corticosteroids and 19% receiving remdesivir, with some receiving both) did however result in a significant reduction in death from any cause by 38% by day 28.


NICE has issued a preliminary rejection for NHS use of Bristol Myers Squibb's Opdivo (nivolumab)/Yervoy (ipilimumab) combination for metastatic non-small-cell lung cancer (NSCLC) in adults whose tumours have no epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) mutations. Clinical trial evidence suggests people who have the regimen live longer than those who have platinum-doublet chemotherapy, but it is uncertain how long the effect lasts and whether PD-L1 status and the type of NSCLC plays a role, the Institute said.