Issues at a former Catalent plant now owned by Novo Nordisk have derailed another FDA application, with Incyte announcing Friday that the FDA handed over a complete response letter for its PD-1 inhibitor Zynyz as a first-line treatment for non-small cell lung cancer (NSCLC).
The rejection was not related to any efficacy or safety concerns but rather inspection findings at a fill-finish facility—specifically, the former Catalent plant in Bloomington, Indiana, which is now owned by Novo as part of Novo Holdings’ $16.5 billion acquisition of the CDMO in 2024.
The setback comes more than a year after Incyte detailed a 25% reduction in the risk of death for a combination of Zynyz and chemotherapy versus chemo alone among patients with newly diagnosed metastatic NSCLC in the phase 3 Pod1um-304 trial.
By clearing that clinical hurdle, Incyte was poised to enter the lucrative first-line NSCLC market, only to be tripped up now by a manufacturing site that has created headaches for several biopharma companies.
Incyte joins a growing list of drugmakers that have seen regulatory timelines delayed by compliance issues at Novo’s Indiana site, referred to as Catalent Indiana in Incyte’s filing. Last year, the facility yielded a pair of CRLs for Regeneron, with one for high-dose Eylea and the other for blood cancer bispecific odronextamab.
Scholar Rock also received a CRL last year thanks to production issues at the ex-Catalent plant, with the company’s spinal muscular atrophy candidate apitegromab denied approval in September.
Problems at the Indiana plant culminated in an FDA warning letter in November. During an inspection in the summer of 2025, the FDA found that the facility failed to properly investigate more than 20 deviations linked to possible contamination of drug product from mammalian hair contamination in or around the stopper region of vials.
In a March 9 statement to Fierce Pharma, a Novo spokesperson said the company is “actively engaging with the agency to address its findings.”
The FDA issued its CRL to Incyte on Feb. 27. The agency delivered another manufacturing-related CRL on the same day to Ferring Pharmaceuticals, hitting the firm’s human recombinant follicle simulating hormone follitropin delta (FE 999049), which is being developed for women undergoing uncontrolled ovarian stimulation. The drug is approved under the brand name Rekovelle in several international markets, such as the EU.
Ferring’s trouble doesn’t seem to come from the Catalent Indiana site. While the Novo manufacturing site’s censure is not related to a specific product, the Ferring CRL followed deficiencies uncovered during a pre-license inspection of a facility, which led to an FDA Form 483, according to the CRL published (PDF) by the FDA.
Fierce Pharma has reached out to Ferring for comment.
As to Incyte, the impact of the CRL is limited. Although first-line NSCLC is the largest indication in oncology, Merck & Co.’s deeply entrenched Keytruda leaves little room for another PD-1 in most developed markets.
Zynyz got its initial FDA nod last year, becoming the first treatment specifically approved in first-line anal cancer. Incyte also announced Friday that the European Commission has authorized the drug for the same use.
Following its May 2025 nod, Zynyz brought in $66.4 million in sales last year. Incyte’s former CEO Hervé Hoppenot previously told Fierce that the company does not expect the PD-1 inhibitor to be a major revenue driver but noted that U.S. approvals may be used as reference for regulators at certain emerging markets.
Editor's Note: The story was updated at 2:45 p.m. ET with a statement from Novo Nordisk.