Policy & Regulation
FDA approves Pembrolizumab with chemotherapy
19 June 2024 -

The US FDA has approved, on Monday Pembrolizumab in combination with carboplatin and paclitaxel, followed by pembrolizumab as a single agent, to treat adult patients with primary, advanced or recurrent endometrial carcinoma.

The approval came after considering data from the phase 3 NRG-GY018 trial (NCT03914612). During tests, it was found that the Pembrolizumab combination reduced disease progression or death compared with Pembrolizumab administered alone.

Endometrial cancer is believed to be the most common gynaecologic cancer in the US. The anti-programmed death receptor-1 (PD-1) therapy works by increasing the immune system's ability to detect and fight tumour cells.