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Breaking News Briefs

Summaries of current approvals by global regulatory agencies of drugs and other treatment-related therapeutic agents used to treat lung cancer and other thoracic neoplasms.

Breaking News Briefs

Lorlatinib Approved for Second- or Third-Line Management of ALK-positive Metastatic NSCLC November 2, 2018—The U.S. Food and Drug Administration granted accelerated approval to lorlatinib...

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...

Breaking News Briefs

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...

Breaking News Briefs

• 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...

Breaking News Briefs

• Dabrafenib and trametidnib (Tafinlar and Mekinist) received FDA approval for use in combination for patients with metastatic non-small cell lung cancer (NSCLC) with...

Breaking News Briefs

• 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...

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