Clovis Oncology says that the FDA demanded fresh efficacy data for the lung cancer drug rociletinib (CO-1686) in order to complete its review. And while the biotech plans to hand that over today, it adds that the fresh data include a worse response rate than expected and could force a delay in the accelerated March 30, 2016, deadline that the FDA had set for a marketing decision.
Merck's immuno-oncology treatment Keytruda met just one of its two goals in a late-stage lung cancer trial, a rare clinical hiccup as it works to keep pace with rival Bristol-Myers Squibb and fortify its position as more contenders move toward the market.
Bristol Myers-Squibb, a leader among companies at work in immuno-oncology, is pressing for wider use of its lead treatment with new data showing the injected drug could succeed as part of a first-line treatment in lung cancer.
Exosome Diagnostics raked in $17.6 million in a second round of Series B financing, bringing the total amount raised to $44.7 million. The company plans to use the funds to support the launch of a few of its products, including two blood-based lung cancer liquid biopsies, a urine-based prostate cancer liquid biopsy and a solid tumor panel.
GE Healthcare got an FDA green light for its low-dose computer tomography (CT) lung cancer screening device, a feather in the company's cap as it deepens its dive into diagnostics imaging.
Behind the headlines here at ASCO, you'll find one of the biggest players in immuno-oncology quietly positioning itself to grab a leading role in the fast-emerging market.
Veracyte has been generating cash for R&D and striking deals to expand its market reach. Now, the company is touting promising results for its bronchial genomic classifier for lung cancer diagnosis as it takes a deeper dive into the lung cancer testing market.
A team of London-based academics is set to trial a stem cell-delivered gene therapy in patients with lung cancer. The 56-person trial is the first time a stem cell-gene therapy combination has been tested in humans in the U.K.
In an effort to detect lung cancer, the Centers for Medicare & Medicaid Services finalized plans to offer Medicare coverage for CT scans, or low-dose computed tomography, among smokers aged 55-77.
Roche's Ventana Medical Systems has submitted its companion diagnostic test for ALK1-positive lung cancer for FDA approval, inching the company closer to full regulatory approval for the product and helping it gain ground in a fiercely competitive cancer diagnostics market.