Hernexeos

FDA Voucher Leads to Speedy Approval of Boehringer Drug for First-Line Use in Lung Cancer

The label expansion for Boehringer Ingelheim’s Hernexeos was made under an FDA pilot program that accelerates regulatory review of products with national interest. The daily pill is now approved as a first-line treatment for HER2-positive non-small lung cancer, an indication with few treatment options.

By Frank Vinluan

BioPharma, Pharma

FDA Nod Makes Boehringer Ingelheim Drug an Alternative to AstraZeneca ADC in Lung Cancer

Boehringer-Ingelheim pill Hernexeos was awarded accelerated FDA approval for advanced cases of non-small cell lung cancer with HER2 mutations. But Bayer is on its heels with an oral small molecule currently under FDA review in the same indication.

By Frank Vinluan