The FDA gave priority review to the British drugmaker's application for Imfinzi in first-line extensive-stage SCLC. Data published last month showed a statistically significant improvement in overall survival for the drug plus chemotherapy compared with chemotherapy alone.
The company said the Phase III CASPIAN study of Imfinzi in first-line, extensive-stage small-cell lung cancer was successful, but did not disclose further details. Roche's Tecentriq is already approved for that indication, which accounts for two-thirds of SCLC cases.
Finding the best analytics tools for health care revenue management can revolutionize operational processes. Compare the leading software options to discover helpful team resources.
The KEYNOTE-119 study failed to show a survival benefit in TNBC patients. The news comes two months after the FDA gave accelerated approval to a rival, Roche's Tecentriq.
The PD-L1 inhibitor is the first new drug for ES-SCLC in more than 20 years. Meanwhile, Merck is also running a Phase III study of its PD-1 inhibitor in first-line ES-SCLC.
The news closely followed that of the FDA approving the first immunotherapy drug for cancer, Roche's Tecentriq, in combination with Abraxane.
The drug received accelerated approval for combination with Celgene's Abraxane based on Phase III data. According to a study, PD-L1-positive patients account for 26 percent of TNBC patients overall.
Discover Houston's best orthopedic surgery centers and what features — from personalized treatment plans to rehabilitation services — make these top providers stand out in their industry.