预约演示
The FDA's approval of Incyte’s Zynyz came as a surprise, its approval marks the eight checkpoint inhibitor to hit the market and the third indicated for metastatic MCC
2023-03-27
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上市批准细胞疗法
Mar. 22, 2023-- Incyte announced that the FDA has approved Zynyz(retifanlimab-dlwr), a humanized monoclonal antibody targeting programmed death receptor-1 (PD-1), for the treatment of adults with metastatic or recurrent locally advanced Merkel cell carcinoma (MCC). The FDA's approval of Incyte’s Zynyz came as a surprise, as the company hadn't disclosed an application filing or a PDUFA date. The drug got the go-ahead through the FDA’s accelerated approval pathway.
Zynyz's approIncyterks the eight
checkpoint inhibitor to Zynyz(retifanlimab-dlwr)programmed death receptor-1 (PD-1)metastatic or recurrent locally advanced Merkel cell carcinoma (MCC)IncyteZynyz
ZynZynyzetifanlimab） is a programmed death receptor-1 (PD-1)-blocking antibody that works to treat Merkel cell carcinoma by binding to the PD-1 protein on immune T-cells to prevent the interaction with the PD-L1 protein on cancer cells. It removes the "brakes" on the immune system, allowing it to attack cancer cells more effectively.
Zynyzd（Retifanlimabug Inteprogrammed death receptor-1 (PD-1)are currently 53 clinical trials for ReMerkel cell carcinoma these trials are fPD-1 proteinindications, including Metastatic Merkel Cell CarcinomaPD-L1 proteinll Carcinoma, Endometrial Carcinoma, and Non-Small Cell Lung Cancer. Metastatic Merkel Cell Carcinoma has been approved for sale in the United States, while other countries are in clinical Phase 2 development at most. Squamous Cell Carcinoma is in the BLA stage in the United States. For more detailed data, please refer to the Synapse.
According to a search of the New Drug Intelligence database: Synapse, Zynyz is the 16th drug apprRetifanlimab1, Merkel Cell Carcinoma is the 8th indication approved for PD-1, Metastatic Merkel Cell Carcinomas Squamous Cell CarcinomaanEndometrial Carcinomaby MetNon-Small Cell Lung CanceromMetastatic Merkel Cell Carcinomah cancer、Uterine Cervical Cancer、Microsatellite Instability cancer、Cutaneous Squamous Cell Carcinoma and Esophageal CSquamous Cell Carcinoma
The third indicated for metastatic
MCC, Zynyz
Merkel cell carcinoma (MCC) is a rare and aggressive type of skin canZynyzhat frequently appears as a sinPD-1 pMerkel Cell Carcinomale skin nodule on the head, neck andPD-1s in skin exposed to sunlight. MCC tends Hodgkin's Lymphomnd haMelanoma rate of metasMetastatic Merkel Cell Carcinoma Microsatellite instability-high cancerrUterine Cervical CanceriMicrosatellite Instability cancereCutaneous Squamous Cell Carcinomaase3.Esophageal Carcinomaan 1 per 100,000 people in the U.S., but incidence rates are rapidly rising, especially in adults over the age of 65.
Search the drug intelligence database: Synapse, a total of 47 drugs and 128 clinical trials were found for the treatment of Merkel Cell Carcinoma. For this indication, the top three research and development organizations are Incyte Corp, Merck & Co., Inc. and Merck KGaA, the major R&D targets are focused on PD-1、PD-L1 and TLR9. The top three types of drug development for this indication are Monoclonal antibody, Small molecule drug, and Fusion protein.
Zynyz is the third drug approved to be markZynyzfor the treatment of Merkel cell carcinoma, the other two being Avelumab, approved in 2017, and Pembrolizumab, approved in 2018.
“Merkel cell carcinoma (MCC)ealthcare professionals an additioskin cancerine anti-PD-1 option for patients with metastatic or recurrent locally advanced MCC, which can be a challenging and aggressive disease to treat,” said Hervé Hoppenot, Chief Executimetastatic disease. “Incyte is grateful to the investigators and patients around the world who participated in the POD1UM-201 trial. We continue to study the potential of Zynyz in additional tumor types and in combination with other Incyte pipeline compounds.”
If you’re interested in learning more about this space or keeping track of drug development and clinical trials, sign up Merkel Cell Carcinoma synapse.patsnap.com ）, our freemium product offering. Incyte CorpMerck & CoMerck KGaAPD-1TLR9
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