FDA announces approvals for sunitinib, obinutuzumab
medwireNews: Following positive decisions by the US Food and Drug Administration (FDA), sunitinib malate can be used as an adjuvant treatment for patients with renal cell carcinoma (RCC) and obinutuzumab can be given in the first-line to individuals with follicular lymphoma.
The announcement specifies that the multitargeted tyrosine kinase inhibitor sunitinib is intended for adult patients who are at high risk for recurrence after nephrectomy and should be given orally at a dose of 50 mg/day for nine cycles, where each cycle involves 4 weeks of treatment followed by a 2-week break.
The decision follows on from the placebo-controlled S-TRAC trial that showed a significant improvement in disease-free survival with sunitinib, at a median of 6.8 years versus 5.6 years for the placebo arm.
Sunitinib comes with a boxed warning alerting physicians and patients to the risk for hepatotoxicity, which can lead to liver failure or death.
Obinutuzumab – an anti-CD20 monoclonal antibody – has been given regular approval for previously untreated adult patients with stage II bulky, III, or IV follicular lymphoma, to be given alongside chemotherapy. Patients achieving at least a partial remission can continue to receive obinutuzumab monotherapy, says the FDA.
The impetus for the decision comes from the phase III GALLIUM trial, in which the obinutuzumab-based regimen outplayed the one based on rituximab in terms of progression-free survival.
The recommended dose of the agent for this patient population is 1000 mg, to be given intravenously on days 1, 8, and 15 of the first cycle and on day 1 of the subsequent 6 or 8 cycles, after which the same dose should be given every 2 months for up to 2 years.
Obinutuzumab also carries a boxed warning for hepatitis B virus reactivation and progressive multifocal leukoencephalopathy.
The anti-CD20 agent had previously been approved by the FDA in combination with bendamustine for the second-line treatment of follicular lymphoma patients who had experienced relapse after receiving a rituximab-containing regimen or been unresponsive to it.
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