AstraZeneca’s immunotherapy treatment Imfinzi did not meet the main goals in a late-stage study for advanced head & neck cancer.
Roche Holding AG’s Tecentriq immunotherapy in combination with Avastin and chemotherapy won U.S. Food and Drug Administration approval as a first-line treatment for a type of lung cancer.
AbbVie halted a Phase III trial evaluating rovalpituzumab tesirine as a second-line therapy for advanced small-cell lung cancer after an Independent Data Monitoring Committee called for the stoppage due to shorter overall survival in the Rova-T arm.
Swiss group Roche Holding AG said the company’s Tecentriq immunotherapy mixed with chemotherapy won priority review from the U.S. regulator for treating a type of lung cancer, a potential boost to the drug that has been trailing rivals’ revenues.
Bristol-Myers Squibb is teaming up with Cancer Research UK and the Francis Crick Institute to create guidelines for immuno-oncology therapy development focused on lung cancer treatments.
The U.S. Food and Drug Administration approved Catalyst Pharmaceuticals Inc.’s drug Firdapse to treat a rare autoimmune disease.
AstraZeneca said the immunotherapy drug Imfinzi did not meet the main goal of improving survival rates for patients with the most advanced form of lung cancer, putting pressure on the company’s shares.
The U.S. Food and Drug Administration approved Pfizer Inc.’s lung-cancer treatment Lorbrena for patients with a specific gene mutation who had been previously treated for an aggressive form of the disease.
Merck’s blockbuster anti-PD-1 therapy Keytruda won FDA approval in combination with chemotherapy as a first-line treatment for patients with metastatic squamous non-small cell lung cancer.
Several PDUFA action dates for drug applications are up for review by the Food and Drug Administration.