Boehringer quietly outmanoeuvres Bayer

Two rival HER2 inhibitors, Boehringer Ingelheim’s Hernexeos and Bayer’s Hyrnuo, have lived nearly parallel lives, scoring concurrent accelerated approvals and recently posting extremely similar results in first-line lung cancer. But Boehringer has used a new US pathway – the commissioner’s national priority voucher (CNPV) programme – for a first-line Hernexeos filing, and it has just revealed that it’s awaiting an approval decision imminently. A positive FDA verdict would give Hernexeos a sudden unexpected lead over Hyrnuo, as Bayer hasn’t announced submitting a first-line filing for its drug. In pretreated, HER2-mutated NSCLC Hernexeos was greenlit on 8 August, while Hyrnuo’s nod came on 19 November. On 6 November the FDA awarded a second batch of CNPVs, and these included Hernexeos for first-line HER2-mutated NSCLC, based on ESMO data. A CNPV shortens FDA review time from 10-12 months to just one or two months, and on Wednesday a Boehringer spokesperson told ApexOnco: “We anticipate hearing news within the coming weeks.” CNPVs have also been given to daraxonrasib for pancreatic cancer and Jemperli for anal cancer, though Revolution and GSK don’t yet appear to have filed for these uses. Hyrnuo isn’t among the CNPV recipients.