Home News Breaking News Briefs

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

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...

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...

Meeting News