MSD’s Keytruda chalks up FDA approval in liver cancer
pharmafile | November 12, 2018 | News story | Sales and Marketing | Cancer, FDA, US, hepatocellular carcinoma, keytruda, pharma
MSD’s blockbuster immunotherapy Keytruda has secured another FDA approval, this time for the treatment of hepatocellular carcinoma (HCC) in patients who have already received current standard of care sorafenib.
The approval, awarded under the agency’s accelerated pathway, comes just days after Eisai’s Lenvima was recommended in England and Wales by NICE for the untreated, advanced, unresectable forms of the same condition.
The FDA’s decision was reportedly based on data which showed that Keytruda demonstrated an overall response rate of 17%, 89% and 56% of which showed a duration of response of at least six or 12 months respectively.
“Hepatocellular carcinoma is the most common type of liver cancer in adults, and while we have seen recent therapeutic advancements, there are still limited treatment options for advanced recurrent disease,” explained Dr Andrew X Zhu, lead investigator and Director of Liver Cancer Research at Massachusetts General Hospital and Professor of medicine at Harvard Medical School. “Today’s approval of Keytruda is important, as it provides a new treatment option for patients with hepatocellular carcinoma who have been previously treated with sorafenib.”
MSD’s Dr Scot Ebbinghaus, Vice President, Clinical Research, also remarked on the decision: “The approval of Keytruda for advanced hepatocellular carcinoma marks the second FDA approval for hepatocellular carcinoma in Merck’s oncology portfolio this year, underscoring our commitment to help bring forward new treatment options for cancers that have historically been very challenging to treat. We look forward to continuing to advance research for hepatocellular carcinoma across our portfolio with the goal to help even more patients affected by this type of cancer.”
Matt Fellows
Related Content
Rethinking oncology trial endpoints with generalised pairwise comparisons
For decades, oncology trials have been anchored to a familiar set of endpoints. Overall survival …
Sharp invests $100m in US and EU manufacturing and packaging facilities
Sharp Services, a pharmaceutical packaging and sterile manufacturing specialist, has announced investments totalling $100m across …
Alto Neuroscience’s schizophrenia treatment granted FDA Fast Track designation
Alto Neuroscience has announced that its investigational treatment for cognitive impairment associated with schizophrenia (CIAS) …
