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Catequentinib sarcoma application withdrawn in EU after negative CHMP opinion and re-examination request

🇪🇺 EMA · Fri 13 Nov 2026

CATS Consultants GmbH pulled its marketing authorisation application for Qezzaqar on 30 October 2026, before EMA's re-examination of a refusal recommendation was completed.

CATS Consultants GmbH has withdrawn its EU marketing authorisation application for Qezzaqar (catequentinib), an oral tyrosine kinase inhibitor intended for two soft tissue sarcomas. EMA published the withdrawal documents on 13 November 2026, giving the withdrawal date as 30 October 2026.

The proposed indications were unresectable or metastatic leiomyosarcoma in adults after two failed therapies, and unresectable or metastatic synovial sarcoma in adults after one failed therapy. For both, prior treatment was to include anthracycline-containing chemotherapy unless patients could not receive it. Qezzaqar was to be supplied as capsules and had orphan designation for soft tissue sarcoma, granted on 22 February 2018.

The CHMP adopted a negative opinion on 23 July 2026. The agency concluded that the progression-free survival benefit was very limited in both conditions and was not backed by objective response or overall survival data. It also cited significant uncertainty about data robustness, noting that small control groups meant baseline differences between participants may have affected the results. On safety, EMA said Qezzaqar, like other VEGF inhibitors, carries important side effects, some serious and fatal.

The main study covered 79 patients with advanced or metastatic synovial sarcoma, who received Qezzaqar or dacarbazine, and 111 with leiomyosarcoma, who received Qezzaqar or placebo. The company requested a re-examination but withdrew before it finished. In its withdrawal letter it cited feedback from EMA's scientific advisory group on oncology and from the CHMP indicating that the agency could not conclude that the benefits outweigh the risks. The company told EMA that patients in clinical trials or compassionate use programmes for the two indications are not affected.

What it means for your team

  • Qezzaqar will not be authorised in the EU through this application (EMEA/H/C/006317), so no marketing authorisation holder safety or labelling obligations arise.
  • The company reports no consequences for patients in clinical trials or compassionate use programmes for these indications; sites involved should follow sponsor instructions.
  • The EMA question-and-answer document (EMA/251385/2026) and the withdrawal letter set out the agency's concerns on efficacy robustness and VEGF-class toxicity, which is useful reading for teams working on comparable sarcoma programmes.
  • Market-access teams can remove Qezzaqar from EU launch or pricing planning based on this application.

Official source: EMA ↗

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

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