- Incyte is pulling its application for an experimental lymphoma medicine after determining that the Food and Drug Administration's requirements for confirmatory studies would be too onerous to "support the investment."
- The Delaware-based biotech had asked the FDA for an accelerated approval of parsaclisib, a conditional clearance based on early results that had yet to be confirmed in further testing. Responding to scrutiny of accelerated approvals, however, the agency recently has pushed drugmakers to complete those trials faster and withdraw indications for products that come up short.
- At the same time, Incyte said Tuesday it's giving up on a partnership with Merus to develop a drug known as MCLA-145, citing its "ongoing portfolio prioritization and capital allocation review." The company will still work with Merus to develop other experimental medicines.
Incyte's move suggests that the FDA is succeeding in reshaping company decisions about pursuing accelerated approvals for cancer treatments. Incyte specifically cited the FDA's timeline for completing confirmatory studies in deciding to withdraw its application for parsaclisib.
Unlike in the past, drugmakers should have confirmatory trials underway or at least fully enrolled when they receive an accelerated approval, FDA cancer drug evaluators Julia Beaver and Richard Pazdur wrote in The New England Journal of Medicine last year. More recently, Pazdur and two other agency officials used a piece in JAMA Oncology to raise the idea of time-limited accelerated approvals that are already in place in other countries.
The issue for the FDA is "dangling" approvals for cancer drugs that are on the market for years without data confirming that truly benefit cancer patients. Just this month, Gilead announced it is withdrawing two indications for Zydelig that received accelerated approvals in 2014 because finding patients for confirmatory testing "has been an ongoing challenge."
In a typical case, the FDA might give an accelerated approval to a drug because it's been shown to shrink tumors, a benefit expected to translate into longer lives for patients. The faster-than-normal approval is meant to give patients quicker access to the medicine, but the agency still expects to see confirmatory evidence later on.
Often, that doesn't happen, or at least not quickly. Last year, the FDA convened a meeting of outside experts to review cases where follow-up research didn't succeed after initially positive results. Multiple companies ultimately withdrew indications for those drugs.
Incyte said its decision isn't related to any changes it's seen in safety or efficacy data for parsaclisib and won't affect ongoing trials. The FDA application was focused on relapsed or refractory follicular lymphoma, marginal zone lymphoma and mantle cell lymphoma. The company is also testing the drug for autoimmune hemolytic anemia and in combination with its Jakafi treatment in myelofibrosis.
Incyte had less to say about its decision to pull out of development of MCLA-145. In its own statement, Merus said regaining worldwide rights to the drug "opens up new possibilities" for the company. Merus is currently enrolling a Phase 1 study of MCLA-145 in solid tumors. Its shares fell 6% in early trading Wednesday.