Incyte breaks new ground in anal cancer with EU approval
Bill Meury, Incyte's chief executive.
A regimen based on Incyte's PD-1 inhibitor Zynyz and chemotherapy has become the first systemic treatment to be approved in the EU for advanced squamous cell carcinoma of the anal canal (SCAC).
Zynyz (retifanlimab) in combination with carboplatin and paclitaxel has been approved by the European Commission as a first-line treatment on the strength of the POD1UM-303 study, which showed that patients with SCAC – the most common form of anal cancer – had longer progression-free survival (PFS) with the regimen compared to those getting chemotherapy alone.
The EU approval differs from that awarded by the FDA last year, which included both front-line use in combination with chemo and a second-line indication as a monotherapy for relapsed SCAC patients. The drug has also been approved in both Europe and the US as a first-line monotherapy for Merkel cell carcinoma, an aggressive type of skin cancer.
Anal cancer is a rare disease, with an estimated prevalence of around 1 or 2 cases per 100,000 people, but SCAC accounts for around 85% of all cases. Most are associated with human papillomavirus (HPV) infection, and it is much more common in people with HIV.
Zynyz has been a small seller for Incyte since it first reached the market in 2023 but has shown signs of acceleration with the SCAC indication. The company posted revenues for the drug of $66 million in 2025, up from just over $3 million in the prior year. Almost half the annual tally – around $32 million – was recorded in the last three months of last year alone.
The growth suggests that, as an approved option, oncologists are gravitating to Zynyz from other drugs in the class, including MSD's top-selling Keytruda (pembrolizumab), which has been used off-label to treat SCAC.
"The EC approval of Zynyz marks an important step forward for patients with advanced SCAC, a rare cancer for which meaningful treatment advances have not occurred in several decades," said Bill Meury, Incyte's chief executive.
J&J gets OK for Akeega in hormone-sensitive prostate cancer
In a second EU approval today, Johnson & Johnson got a green light for Akeega (niraparib and abiraterone acetate) for the treatment of metastatic hormone-sensitive prostate cancer (mHSPC) with BRCA1/2 mutations, a few weeks after the new indication was approved by the FDA.
This marks the first approval for a PARP inhibitor-based precision medicine combination in the EU for this patient population.
Akeega is already approved in the EU for BRCA-mutated metastatic castration-resistant prostate cancer (mCRPC) in patients who can't be treated with chemo, but J&J has been in the lead for extending the use of PARP drugs into the hormone-sensitive disease, which GlobalData has suggested could underpin predicted sales of more than $675 million by the end of the decade.
