RegulatoryOfficial

CHMP backs Zybrivo (sintilimab) for first-line non-squamous NSCLC in combination with chemotherapy

🇪🇺 EMA · Fri 13 Nov 2026

The EMA committee adopted a positive opinion on 12 November 2026 for Fortvita Biologics' PD-1 antibody, recommending marketing authorisation for adults with non-squamous non-small cell lung cancer.

The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion on 12 November 2026, recommending a marketing authorisation for Zybrivo (sintilimab). The applicant is Fortvita Biologics (Ireland) Limited. The EMA product number is EMEA/H/C/006743. Zybrivo will be supplied as a 100 mg concentrate for solution for infusion.

The recommended indication is first-line treatment of adults with non-squamous non-small cell lung cancer (NSCLC), given with pemetrexed and platinum-based chemotherapy. Patients must have no EGFR or ALK genomic tumour aberrations. They must also have either locally advanced disease and not be candidates for curative-intent surgical resection or chemoradiation, or metastatic disease.

EMA describes the benefit as improved progression-free survival when sintilimab is added to chemotherapy, compared with chemotherapy alone. The data come from a randomised, multicentre, double-blind, placebo-controlled study in adults with stage IIIB or IIIC disease who were ineligible for radical surgery or curative-intent chemoradiation, or with stage IV or recurrent non-squamous NSCLC. Enrolment was regardless of PD-L1 expression. Patients with EGFR or ALK aberrations were excluded.

The most common side effects listed are anaemia, neutropenia, leukopenia, thrombocytopenia, decreased appetite, nausea, fatigue, raised aspartate and alanine aminotransferases, pyrexia, hypothyroidism and rash. Treatment should be started and supervised by physicians experienced in cancer therapy. Sintilimab is an antineoplastic monoclonal antibody that blocks PD-1 from binding to PD-L1 and PD-L2, which potentiates T-cell responses, including anti-tumour responses.

The detailed SmPC will be published in all official EU languages only after the European Commission grants the marketing authorisation. A CHMP opinion is a recommendation, and the Commission decision is the formal step that follows it.

What it means for your team

  • This is a CHMP positive opinion, not a marketing authorisation. Final SmPC, labelling and risk management plan details will follow the European Commission decision.
  • Regulatory and market-access teams should read the CHMP summary of opinion (reference EMADOC-1829012207-79095). The indication is limited to the combination with pemetrexed and platinum chemotherapy in EGFR/ALK-negative non-squamous NSCLC, which defines the competitive and reimbursement scope.
  • Pharmacovigilance teams can note the listed common adverse reactions, which include haematological toxicities, raised transaminases and hypothyroidism, as early pointers for monitoring and signal-detection planning once the product is authorised.

Official source: EMA ↗

Article written by VigiEye from the official source (EMA). AI-assisted; check the source before acting.

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