"Importance of favourable and unfavourable effects
The magnitude of response rates shown in the two clinical studies is considered very clinically relevant, especially for, but not restricted to, CML patients harbouring the T315I mutation.
The most common unfavourable effects include gastrointestinal events, rash and other skin events, infections, myelosuppression, fluid retention, pancreatitis, fatigue, and myalgia. However, most of the common unfavourable effects were well-managed with the dose reduction/ dose delay regimen used in the pivotal trial."
"Benefit-risk balance
In a patient population, that includes patients with the T315I mutation, or patients who resistant to treatment with dasatinib/ nilotinib, the clinical benefits are considered relevant and outweigh the potential risks, which to large extent appear manageable. The same benefit-risk balance can also be concluded in a patient population intolerant to dasatinib or nilotinib, and for whom subsequent treatment with imatinib is clinically inappropriate. It is however noted that although patients with Ph+ ALL pre-treated with nilotinib have been included in the clinical studies, nilotinib is not approved in the treatment of Ph+ ALL patients which is reflected in section 4.1 of the SmPC."
Liest sich beim überfliegen alles gut, entscheidend wird allerdings sein, ob die FDA das über kurz oder lang auch sieht ... |
Thread abonnieren
