MEI Pharma and Kyowa Kirin will stop development, outside of Japan, of an experimental lymphoma drug after concluding that clincial trial requirements imposed by the Food and Drug Administration will be too costly, the companies said Monday.
The two companies will continue working toward potential approval in Japan, where the drug, called zandelisib, is in a Phase 2 trial in patients with non-Hodgkin lymphomas that have progressed following initial treatment.
MEI and Kyowa had hoped to win accelerated approval for zandelisib based on the results of a Phase 2 trial in follicular lymphoma, an uncommon form of the disease for which other drugs in zandelisib’s class, called PI3 kinase inhibitors, have been cleared for use. The trial showed that in follicular lymphoma patients who’d previously received two systemic treatments, 70% of them responded to zandelisib and 35% achieved a complete remission. The trial didn’t have a placebo arm or active treatment to compare against.
However, the FDA in March decided that before it could approve the drug, the companies needed to complete a Phase 3 trial that tests a combination of zandelisib and Rituxan against Rituxan and chemotherapy in a wider array of non-Hodgkin lymphomas.
That ruling was followed a month later by a meeting of outside FDA advisers who, in a 16-0 vote, recommended that before approval, all PI3 kinase inhibitor drugs must have data from a trial that compares them to an active treatment or a placebo because of concerns about side effects.
A late November meeting with regulators led MEI and Kyowa to subsequently discontinue research outside Japan, the companies said.
“In light of FDA’s guidance, we no longer believe clinical development can be completed within a time period that would support further investment, or with sufficient certainty of the regulatory requirements to justify continued global development efforts,” MEI CEO Daniel Gold said in a written statement.
Shares in MEI fell 28% in midday trading on Monday.
MEI and Kyowa’s decision comes as the FDA is starting to take a harder line on accelerated approvals. Those approvals are a tool for the agency to speed new drugs to market for patients with deadly or disabling diseases, but they’re conditional clearances that are meant to be withdrawn if benefits aren’t confirmed with additional testing.
In many cases, drugmakers have taken years to complete those trials, or haven’t completed them at all. The FDA until recently has been unwilling to force withdrawals, but that stance appears to be changing. Amid agency scrutiny and following failures in confirmatory trials, some manufacturers have withdrawn previously approved indications for cancer immunotherapies. Last week, for instance, Roche pulled Tecentriq from the market in bladder cancer, the first condition it was approved to treat.
Meanwhile, the agency is trying to force Covis Pharma to withdraw Makena, a shot that’s meant to prevent pre-term births. The drug failed a confirmatory Phase 3 trial, but the regulatory process to remove it from the market has taken years.