The Priority Review

Tag

Zybrivo

2 stories

Stories

  1. Approvals

    EMA recommends approval of seven new medicines at CHMP meeting

    The Committee for Medicinal Products for Human Use (CHMP) recommended granting marketing authorization for Aumseqa, Baxfendy, Zybrivo, Garzulys, Donrafylix, Fondaparinux sodium Evumed, and Ruxolitinib Krka. The recommendations cover treatments for non-small cell lung cancer, hypertension, non-squamous non-small cell lung cancer, diabetes, venous thromboembolism, and myelofibrosis, among others.

  2. Approvals

    CHMP adopts positive opinion on Zybrivo for non-squamous NSCLC

    On 12 November 2026 the CHMP recommended granting a marketing authorization for Zybrivo, a sintilimab-based therapy, for first-line treatment of adult non-squamous non-small cell lung cancer. The recommendation follows a randomised, multicentre, double-blind, placebo-controlled study showing improved progression-free survival when sintilimab is combined with chemotherapy.