Regorafenib (2) – Stivarga®

Patients with unresectable or metastatic gastrointestinal stromal tumours (GIST) who have progressed on, or are intolerant of, prior treatment with imatinib and sunitinib

• As the required proof has not been submitted in full, the additional benefit in relation to the appropriate comparator therapy is deemed not proven (Section 35a(1), fifth sentence, of Book V of the Social Code [SGB V]).
• The pharmaceutical manufacturer therefore provided no information on the medical benefit or the additional medical benefit compared with the appropriate comparator therapy.
• It was therefore not possible to assess whether the active ingredient regorafenib offers additional benefit, no additional benefit or less benefit compared with the appropriate comparator therapy.
• Appropriate comparator therapy
  • The appropriate comparator therapy for patients with unresectable or metastatic gastrointestinal stromal tumours (GIST) is:
  • Best Supportive Care
  • ‘Best supportive care’ (BSC) is defined as the treatment that ensures the best possible, individually optimised supportive care to alleviate symptoms and improve quality of life.
  • Gastrointestinal stromal tumours (GISTs) are resistant to cytotoxic chemotherapy; therefore, chemotherapy, as well as imatinib and sunitinib, are not routinely part of BSC.

Courtesy translation only, please refer to the German original.