A panel of expert advisers will meet on Thursday to discuss whether a lung cancer therapy that has been studied only in China should be approved in the US based on its Chinese trials.
The drug, sintilimab, from Chinese cancer drug developer Innovent Biologics and US drugmaker Eli Lilly and Co, has been developed and commercialised under a global agreement.
Lilly and Innovent currently sell the drug, marketed as Tyvyt in China, pictured below, where it was approved for relapsed or resistant to treatment classic Hodgkin’s lymphoma after at least two lines of chemotherapy.
Innovent’s marketing application was accepted for review in May by the US Food and Drug Administration, which will convene Thursday’s meeting.
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 non-squamous non-small cell lung cancer – the most lucrative cancer market.
PFS – the time it takes for the cancer to begin to worsen – was almost nine months for sintilimab versus five 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 the UK’s AstraZeneca, Swiss drugmaker Roche and US biotech Amgen that have made big investments in the hopes of benefiting from cheaper trial costs in China.
The FDA reviewers said multinational clinical trials are the preferred international standard for drug development and allow for an evaluation of consistency of treatment effects in many geographies.
Innovent, based in Suzhou, said in its briefing document that the drug has demonstrated a positive benefit-risk profile, adding that China’s clinical practice standards are similar to those of the US.
Lilly, which has the exclusive licence for the drug outside China, said last week it believes the study data are applicable to the US population.
- Reuters, with additional editing by George Russell