Protocols

Merck’s Keytruda wins US approval for wider lung cancer population; CymaBay breaks out positive data from ongoing PBC study

→ Days after Merck’s entrenched flagship Keytruda immunotherapy scored a key lung cancer approval in China, the drugmaker has expanded its lung cancer market at home by winning approval for as a monotherapy for the first-line treatment of patients with stage III NSCLC, who are not candidates for surgical resection or definitive chemoradiation, as well as patients with metastatic NSCLC, whose tumors express PD-L1, with no EGFR or ALK genomic tumor aberrations. “This expanded first-line indication now makes Keytruda monotherapy an option for more patients with non-small cell lung cancer, including those for whom combination therapy may not be appropriate,” said Merck’s $MRK VP of oncology clinical research, Jonathan Cheng, in a statement on Thursday.

→ Liver drug developer CymaBay Therapeutics $CBAY, whose PBC and NASH drug seladelpar has received glowing reviews so far, on Friday broke out some data on 25 cirrhotic patients from an ongoing Phase II study in PBC patients. The data suggested that “seladelpar treatment…maintained a potent anti-cholestatic effect over 52 weeks,” the company said in a statement, adding that the drug appeared to be safe, well-tolerated, and was not associated with pruritus (a sticky issue seen with Intercept’s $ICPT NASH/PBC drug) or hepatotoxicity.

→ Founded by a former Exact Sciences $EXAS executive, China-based colorectal cancer detection company Creative Biosciences scored RMB300 million (US$44.64 million) in a Series B round, co-led by IDG Capital and CDH Investments, according to a report by China Money Network. Last November, the company’s DNA-based colorectal cancer screening diagnostic kit was granted approved by China’s National Medical Products Administration.


The best place to read Endpoints News? In your inbox.

Comprehensive daily news report for those who discover, develop, and market drugs. Join 47,300+ biopharma pros who read Endpoints News by email every day.

Free Subscription

Research Scientist - Immunology
Recursion Pharmaceuticals Salt Lake City, UT
Director of Operations
Atlas Venture Cambridge, MA

Visit Endpoints Careers ->