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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

• Clovis Oncology is shutting down patient enrollment in clinical trials of its lung cancer drug rociletinib, which targets T790m, a mutation responsible for...

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

RECENT APPROVALS: Pembrolizumab (Keytruda) was approved by the FDA for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors express...

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

• 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

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

• 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

• 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

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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