Retifanlimab, sold under the brand name Zynyz, is an
anti-cancer medication
Chemotherapy (often abbreviated chemo, sometimes CTX and CTx) is the type of cancer treatment that uses one or more anti-cancer drugs ( chemotherapeutic agents or alkylating agents) in a standard regimen. Chemotherapy may be given with a cu ...
used for the treatment of
Merkel cell carcinoma
Merkel cell carcinoma (MCC) is a rare and aggressive skin cancer occurring in about three people per million members of the population. It is also known as cutaneous APUDoma, Primary tumor, primary neuroendocrine tumor, neuroendocrine carcinoma ...
.
Retifanlimab is a
programmed death receptor-1 (PD-1)–blocking
monoclonal antibody
A monoclonal antibody (mAb, more rarely called moAb) is an antibody produced from a cell lineage made by cloning a unique white blood cell. All subsequent antibodies derived this way trace back to a unique parent cell.
Monoclonal antibodie ...
.
It was approved for medical use in the United States in March 2023,
[ ] and in the European Union in April 2024.
Medical uses
Retifanlimab is
indicated
In medicine, an indication is a valid reason to use a certain test, medication, procedure, or surgery. There can be multiple indications to use a procedure or medication. An indication can commonly be confused with the term diagnosis. A diagnosis ...
for the treatment of adults with metastatic or recurrent locally advanced Merkel cell carcinoma.
In May 2025, the US
Food and Drug Administration
The United States Food and Drug Administration (FDA or US FDA) is a List of United States federal agencies, federal agency of the United States Department of Health and Human Services, Department of Health and Human Services. The FDA is respo ...
(FDA) expanded the indication for retifanlimab to include, when used with
carboplatin
Carboplatin, sold under the brand name Paraplatin among others, is a chemotherapy medication used to treat a number of forms of cancer. This includes ovarian cancer, lung cancer, head and neck cancer, brain cancer, and neuroblastoma. It is a ...
and
paclitaxel
Paclitaxel, sold under the brand name Taxol among others, is a chemotherapy medication used to treat ovarian cancer, esophageal cancer, breast cancer, lung cancer, Kaposi's sarcoma, cervical cancer, and pancreatic cancer. It is administered b ...
, the
first-line treatment
A therapy or medical treatment is the attempted remediation of a health problem, usually following a medical diagnosis. Both words, ''treatment'' and ''therapy'', are often abbreviated tx, Tx, or Tx.
As a rule, each therapy has indications an ...
of adults with inoperable locally recurrent or metastatic
squamous-cell carcinoma
Squamous-cell carcinoma (SCC), also known as epidermoid carcinoma, comprises a number of different types of cancer that begin in squamous cells. These cells form on the surface of the skin, on the lining of hollow organs in the body, and on the ...
of the anal canal.
The FDA also approved retifanlimab, as a single agent, for adults with locally recurrent or metastatic squamous-cell carcinoma of the anal canal with disease progression on or intolerance to
platinum-based chemotherapy
Platinum-based antineoplastic drugs (informally called platins) are chemotherapeutic agents used to treat cancer. Their active moieties are coordination complexes of platinum. These drugs are used to treat almost half of people receiving chemothe ...
.
[ ]
Adverse effects
The US
Food and Drug Administration
The United States Food and Drug Administration (FDA or US FDA) is a List of United States federal agencies, federal agency of the United States Department of Health and Human Services, Department of Health and Human Services. The FDA is respo ...
(FDA) prescription label for retifanlimab includes warnings and precautions for severe and fatal immune-mediated adverse reactions, infusion-related reactions, complications of allogeneic HSCT, and embryo-fetal toxicity.
History
The US
Food and Drug Administration
The United States Food and Drug Administration (FDA or US FDA) is a List of United States federal agencies, federal agency of the United States Department of Health and Human Services, Department of Health and Human Services. The FDA is respo ...
(FDA) evaluated the safety and efficacy of retifanlimab based on PODIUM-201 (NCT03599713), an open-label, multiregional, single-arm study evaluating 65 participants with metastatic or recurrent locally advanced MCC who had not received prior systemic therapy for advanced disease.
The FDA granted the application for retifanlimab
priority review
Priority review is a program of the United States Food and Drug Administration (FDA) to expedite the review process for drugs that are expected to have a particularly great impact on the treatment of a disease. The priority review voucher program ...
,
fast track
Fast Track, Fast track, or Fasttrack may refer to:
Processes and systems
* Fast track (FDA), a U.S. Food and Drug Administration expedited review program
* Fast track (trade), the authority of the U.S. President to broker trade agreements with lim ...
, and
orphan drug
An orphan drug is a medication, pharmaceutical agent that is developed to treat certain rare medical conditions. An orphan drug would not be profitable to produce without government assistance, due to the small population of patients affected by th ...
designations.
The efficacy of retifanlimab with carboplatin and paclitaxel was evaluated in POD1UM-303/InterAACT 2 (NCT04472429), a randomized, multi-center, double-blind trial in 308 participants with chemotherapy-naïve inoperable locally recurrent or metastatic squamous-cell carcinoma of the anal canal.
Participants received carboplatin AUC of 5 on day 1, and paclitaxel 80 mg/m on days 1, 8, and 15 for 6 cycles and were randomized (1:1) to receive either retifanlimab 500 mg intravenously every 4 weeks; or placebo intravenously every 4 weeks.
The efficacy of retifanlimab as a single agent was evaluated in POD1UM-202 (NCT03597295), an open-label, multi-center, single-arm trial in 94 participants with locally recurrent or metastatic SCAC with disease progression on or intolerance to platinum-based chemotherapy.
Participants received retifanlimab 500 mg intravenously every 4 weeks until disease progression, unacceptable toxicity, or up to 24 months.
Society and culture
Legal status
In February 2024, the
Committee for Medicinal Products for Human Use
The Committee for Medicinal Products for Human Use (CHMP), formerly known as the Committee for Proprietary Medicinal Products (CPMP), is the European Medicines Agency's committee responsible for elaborating the agency's opinions on all issues regar ...
of the
European Medicines Agency
The European Medicines Agency (EMA) is an agency of the European Union (EU) in charge of the evaluation and supervision of pharmaceutical products. Prior to 2004, it was known as the European Agency for the Evaluation of Medicinal Products ...
adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Zynyz, intended for the treatment of Merkel cell carcinoma.
The applicant for this medicinal product is Incyte Biosciences Distribution B.V.
[ Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.] Retifanlimab was authorized for medical use in the European Union in April 2024.
Names
Retifanlimab is the
international nonproprietary name.
Retifanlimab is sold under the brand name Zynyz.
References
External links
*
{{Portal bar , Medicine
Monoclonal antibodies for tumors
Orphan drugs