Breaking News Briefs
FDA Grants Priority Review for sBLA for Pembrolizumab
July 2, 2018—The U.S. Food and Drug Administration (FDA) granted a priority review for a supplemental biologics license application (sBLA)...
Breaking News Briefs
Nivolumab in the News
The dosing schedule for nivolumab now includes a flat dose of 480 mg infused every 4 weeks (Q4W) for a majority...
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Tumors with high TMB responded well to combination in large patient population.
By now the results of the phase III CheckMate-227 study are known...
Breaking News Briefs
The FoundationOne CDx (F1CDx) test received full U.S. Food and Drug Administration (FDA) approval. F1CDx is the first breakthrough-designated, next-generation sequencing–based in vitro diagnostic...
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• Alectinib (Alecensa) received full FDA approval for the first-line treatment of patients with ALK-positive metastatic non-small cell lung cancer (NSCLC) as determined by...
Breaking News Briefs
• Alectinib received FDA priority review designation for first-line treatment of patients with ALK-positive, locally advanced or metastatic NSCLC. The supplemental new drug application...
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• Dabrafenib and trametidnib (Tafinlar and Mekinist) received FDA approval for use in combination for patients with metastatic non-small cell lung cancer (NSCLC) with...
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• Pembrolizumab (Keytruda) received FDA approval for use in combination with pemetrexed and carboplatin for the first-line treatment of patients with metastatic nonsquamous NSCLC,...
Breaking News Briefs
• The global, randomized phase III ALEX study was announced to have met its primary endpoint, demonstrating that alectinib (Alecensa), as an initial (first-line)...
Breaking News Briefs
Alectinib (Alecensa) received a positive opinion from the European Medicines Agency (EMA) for Medicinal Products for Human Use (CHMP) for the treatment of adult...
