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INCY Wins EC Approval for Label Expansion of Oncology Drug Zynyz
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Key Takeaways
INCY gained EU approval for Zynyz with chemotherapy as first-line treatment for metastatic or recurrent SCAC.
Zynyz cut risk of progression or death by 37% in POD1UM-303, with 9.3-month median PFS vs 7.4 for placebo.
Incyte is expanding its oncology portfolio as Zynyz complements revenue driver Jakafi.
Incyte (INCY - Free Report) recently announced that the European Commission has approved a label expansion of oncology drug Zynyz (retifanlimab) for a second indication.
The drug is now approved in the EU in combination with chemotherapy for the first-line treatment of adults with metastatic or inoperable locally recurrent squamous cell carcinoma of the anal canal (SCAC).
Zynyz is a PD-1 immune checkpoint inhibitor designed to help the immune system recognize and attack cancer cells.
The decision marks the first systemic treatment approved in Europe for newly diagnosed patients with advanced SCAC and expands Incyte’s growing oncology portfolio.
Shares of Incyte have gained 34.4% in the past year compared with the industry’s 12.5% growth.
Image Source: Zacks Investment Research
More on INCY’s Zynyz
The EC approval was based on results from the late-stage POD1UM-303 (InterAACT2) study, which evaluated Zynyz or placebo in combination with platinum-based chemotherapy (carboplatin and paclitaxel) in adult patients with metastatic or inoperable locally recurrent SCAC not previously treated with systemic chemotherapy.
The study results demonstrated a statistically significant 37% reduction in the risk of progression or death. Patients treated with Zynyz achieved a median progression-free survival of 9.3 months, compared with 7.4 months for patients in the placebo combination group.
Improvements were also observed across secondary endpoints, including overall survival.
Importantly, the safety profile of the combination therapy was generally consistent with other PD-1 inhibitor and chemotherapy combinations.
The EC decision follows the positive Committee for Medicinal Products for Human Use (CHMP) opinion received from the European Medicines Agency in January 2026.
We note that the drug is already approved for the first-line treatment of adult patients with inoperable locally recurrent or metastatic SCAC in the United States and Japan. It is also approved as a single agent for the treatment of adult patients with locally recurrent or metastatic SCAC with disease progression or intolerance to platinum-based chemotherapy in the United States.
In addition, Zynyz is approved as a monotherapy for the first-line treatment of adults with metastatic or recurrent locally advanced merkel cell carcinoma in the United States, European Union, Canada and Switzerland.
The drug is marketed in the United States by Incyte. In 2017, the company entered into an exclusive collaboration and licensing agreement with MacroGenics for global rights to retifanlimab.
The POD1UM clinical program for retifanlimab includes POD1UM-303, POD1UM-202 and several other studies in different stages for patients with solid tumors.
INCY’s Efforts to Expand Portfolio
Incyte’s efforts to develop new drugs to diversify its portfolio and add an incremental stream of revenues are impressive.
At present, lead drug Jakafi accounts for the lion’s share of revenues.
The lead drug, Jakafi, is a JAK1/JAK2 inhibitor approved for the treatment of polycythemia vera (PV) in adults who have had an inadequate response to or are intolerant of hydroxyurea; intermediate or high-risk myelofibrosis (MF), including primary MF, post-polycythemia vera MF and post-essential thrombocythemia MF in adults; steroid-refractory acute graft-versus-host disease (GVHD) in adult and pediatric patients 12 years and older; and chronic GVHD after failure of one or two lines of systemic therapy in adult and pediatric patients aged 12 years and older.
Sales in all indications continue to be strong and should maintain momentum going forward.
Jakafi is marketed by Incyte in the United States and by Novartis (NVS - Free Report) as Jakavi in ex-U.S. markets.
Incyte earns product royalty revenues from Novartis for the commercialization of Jakavi in ex-U.S. markets.
Encouraging uptake of new drugs like Pemazyre, Monjuvi and Tabrecta contributes to its top-line growth.
Incyte also receives royalties from the sales of Tabrecta (capmatinib), which is approved for treating adult patients with metastatic non-small cell lung cancer. Novartis has exclusive worldwide development and commercialization rights to Tabrecta.
The pipeline progress is impressive as well. Incyte expects to have 14 pivotal clinical trials underway by year-end.
INCY’s Zacks Rank & Stocks to Consider
INCY currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the drug/biotech sector are Catalyst Pharmaceuticals (CPRX - Free Report) and ANI Pharmaceuticals (ANIP - Free Report) . While Catalyst Pharmaceuticals currently sports a Zacks Rank #1 (Strong Buy), ANI Pharmaceuticals holds a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Over the past 60 days, estimates for Catalyst Pharmaceuticals’ 2026 earnings per share have increased from $2.53 to $2.82, and the same for 2027 have grown from $2.85 to $3.20. CPRX’s shares have risen 17% in the past year.
Catalyst Pharmaceuticals’ earnings beat estimates in each of the trailing four quarters, with the average surprise being 35.19%.
Over the past 60 days, estimates for ANI Pharmaceuticals’ 2026 earnings per share have increased from $8.20 to $9.00, while the same for 2027 have risen from $9.25 to $10.10. ANIP’s shares have gained 25.9% in the past year.
ANI Pharmaceuticals’ earnings beat estimates in each of the trailing four quarters, with the average surprise being 22.21%.
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INCY Wins EC Approval for Label Expansion of Oncology Drug Zynyz
Key Takeaways
Incyte (INCY - Free Report) recently announced that the European Commission has approved a label expansion of oncology drug Zynyz (retifanlimab) for a second indication.
The drug is now approved in the EU in combination with chemotherapy for the first-line treatment of adults with metastatic or inoperable locally recurrent squamous cell carcinoma of the anal canal (SCAC).
Zynyz is a PD-1 immune checkpoint inhibitor designed to help the immune system recognize and attack cancer cells.
The decision marks the first systemic treatment approved in Europe for newly diagnosed patients with advanced SCAC and expands Incyte’s growing oncology portfolio.
Shares of Incyte have gained 34.4% in the past year compared with the industry’s 12.5% growth.
Image Source: Zacks Investment Research
More on INCY’s Zynyz
The EC approval was based on results from the late-stage POD1UM-303 (InterAACT2) study, which evaluated Zynyz or placebo in combination with platinum-based chemotherapy (carboplatin and paclitaxel) in adult patients with metastatic or inoperable locally recurrent SCAC not previously treated with systemic chemotherapy.
The study results demonstrated a statistically significant 37% reduction in the risk of progression or death. Patients treated with Zynyz achieved a median progression-free survival of 9.3 months, compared with 7.4 months for patients in the placebo combination group.
Improvements were also observed across secondary endpoints, including overall survival.
Importantly, the safety profile of the combination therapy was generally consistent with other PD-1 inhibitor and chemotherapy combinations.
The EC decision follows the positive Committee for Medicinal Products for Human Use (CHMP) opinion received from the European Medicines Agency in January 2026.
We note that the drug is already approved for the first-line treatment of adult patients with inoperable locally recurrent or metastatic SCAC in the United States and Japan. It is also approved as a single agent for the treatment of adult patients with locally recurrent or metastatic SCAC with disease progression or intolerance to platinum-based chemotherapy in the United States.
In addition, Zynyz is approved as a monotherapy for the first-line treatment of adults with metastatic or recurrent locally advanced merkel cell carcinoma in the United States, European Union, Canada and Switzerland.
The drug is marketed in the United States by Incyte. In 2017, the company entered into an exclusive collaboration and licensing agreement with MacroGenics for global rights to retifanlimab.
The POD1UM clinical program for retifanlimab includes POD1UM-303, POD1UM-202 and several other studies in different stages for patients with solid tumors.
INCY’s Efforts to Expand Portfolio
Incyte’s efforts to develop new drugs to diversify its portfolio and add an incremental stream of revenues are impressive.
At present, lead drug Jakafi accounts for the lion’s share of revenues.
The lead drug, Jakafi, is a JAK1/JAK2 inhibitor approved for the treatment of polycythemia vera (PV) in adults who have had an inadequate response to or are intolerant of hydroxyurea; intermediate or high-risk myelofibrosis (MF), including primary MF, post-polycythemia vera MF and post-essential thrombocythemia MF in adults; steroid-refractory acute graft-versus-host disease (GVHD) in adult and pediatric patients 12 years and older; and chronic GVHD after failure of one or two lines of systemic therapy in adult and pediatric patients aged 12 years and older.
Sales in all indications continue to be strong and should maintain momentum going forward.
Jakafi is marketed by Incyte in the United States and by Novartis (NVS - Free Report) as Jakavi in ex-U.S. markets.
Incyte earns product royalty revenues from Novartis for the commercialization of Jakavi in ex-U.S. markets.
Encouraging uptake of new drugs like Pemazyre, Monjuvi and Tabrecta contributes to its top-line growth.
Incyte also receives royalties from the sales of Tabrecta (capmatinib), which is approved for treating adult patients with metastatic non-small cell lung cancer. Novartis has exclusive worldwide development and commercialization rights to Tabrecta.
The pipeline progress is impressive as well. Incyte expects to have 14 pivotal clinical trials underway by year-end.
INCY’s Zacks Rank & Stocks to Consider
INCY currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the drug/biotech sector are Catalyst Pharmaceuticals (CPRX - Free Report) and ANI Pharmaceuticals (ANIP - Free Report) . While Catalyst Pharmaceuticals currently sports a Zacks Rank #1 (Strong Buy), ANI Pharmaceuticals holds a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Over the past 60 days, estimates for Catalyst Pharmaceuticals’ 2026 earnings per share have increased from $2.53 to $2.82, and the same for 2027 have grown from $2.85 to $3.20. CPRX’s shares have risen 17% in the past year.
Catalyst Pharmaceuticals’ earnings beat estimates in each of the trailing four quarters, with the average surprise being 35.19%.
Over the past 60 days, estimates for ANI Pharmaceuticals’ 2026 earnings per share have increased from $8.20 to $9.00, while the same for 2027 have risen from $9.25 to $10.10. ANIP’s shares have gained 25.9% in the past year.
ANI Pharmaceuticals’ earnings beat estimates in each of the trailing four quarters, with the average surprise being 22.21%.