By Ankur Banerjee
(Reuters) – A panel of expert advisers to the U.S. Food and Drug Administration will meet on Thursday to discuss whether a lung cancer therapy that has been studied only in China should be approved in the United States, and whether trial results are applicable to the U.S. population.
The drug, sintilimab, from Chinese cancer drug developer Innovent Biologics Inc and U.S. drugmaker Eli Lilly and Co, has been developed and commercialized under a global agreement.
Lilly and Innovent currently sell the drug, marketed as Tyvyt in China, where it was approved for relapsed or resistant to treatment classic Hodgkin’s lymphoma after at least two lines of chemotherapy.
Jiangsu-based Innovent’s marketing application was accepted for review by the FDA in May.
In a late-stage study, Innovent said the drug in combination with Lilly’s Alimta and platinum chemotherapy met the main goal of progression-free survival (PFS) in patients with advanced or recurrent nonsquamous non-small cell lung cancer – the most lucrative cancer market.
PFS – the time it takes for the cancer to begin to worsen – was almost 9 months for sintilimab versus 5 months among those who received a placebo.
In a briefing document published on Tuesday ahead of the meeting, FDA staff reviewers said the patient population in the single country trial does not reflect the diversity of the American population.
The comments highlight the challenge facing drugmakers including Britain-based AstraZeneca Plc, Swiss drugmaker Roche Holding and U.S. biotech Amgen Inc that have made big investments in the hopes of benefiting from cheaper trial costs in China.
The FDA reviewers said multi-national clinical trials are the preferred international standard for drug development and allow for an evaluation of consistency of treatment effects in many geographies.
Innovent in its briefing document said the drug has demonstrated a positive benefit-risk profile, adding that clinical practice standards are similar between China and the United States.
Lilly, which has the exclusive license for the drug outside China, said last week it believes the study data are applicable to the U.S. population.
Richard Pazdur, director of the FDA’s Oncology Center of Excellence, expressed concerns about an increasing number of cancer drugs based solely or predominantly on clinical data from China in an essay published last week in Lancet Oncology.
The trial raises questions regarding the data from a single foreign country to support U.S. approval and if the data can be generalized to the American population, Pazdur wrote in the article titled, “Importing oncology trials from China: a bridge over troubled waters?”
Jefferies equity analysts said the committee is likely to recommend that additional clinical trials be required to demonstrate the drug’s applicability in U.S. patients and to suggest the agency defers a regulatory decision.
(Reporting by Ankur Banerjee in Bengaluru; Editing by Bill Berkrot)
