Express . . . Keytruda is qualified by the FDA for priority review, single-drug treatment for recurrent/refractive classic Hodgkin's lymphoma.
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Last Update: 2020-07-17
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Source: Internet
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Author: User
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▎ recently, MSD announced that the US Food and Drug Administration (FDA) has accepted its application for the license of supplementary biological products (SBLA) for the heavyweight PD-1 inhibitor keytruda, and has granted it priority for review as a monotherapy for adult patients with relapsed / refractory classical Hodgkin's lymphoma (CHL).it is expected that a reply will be made before October 30 this year.Hodgkin's lymphoma is a tumor caused by lymphocytes, which are part of the immune system.Hodgkin's lymphoma can occur almost anywhere in the body. Lymph nodes in the upper part of the body are more common. The most common sites are the chest, neck or armpit.globally, there were about 80000 new cases of Hodgkin's lymphoma in 2018, and more than 26000 died as a result.in developed countries, classical Hodgkin's lymphoma accounts for more than 90% of Hodgkin's lymphoma.this SBLA is based on data from a key phase 3 clinical trial, keynote-204, in which keyruda significantly improved progression free survival (PFS) compared to current standard therapy for this patient population.} PFS results of keynote-204 (image source: MSD official website) "classic Hodgkin's lymphoma accounts for more than 90% of Hodgkin's lymphoma. If they can't enter remission stage after receiving first-line treatment, their treatment options are limited and their prognosis is particularly poor," said Jonathan, vice president of clinical oncology research, Merck Research Laboratory "We look forward to working with the FDA to bring keyruda to more patients with treated classical Hodgkin's lymphoma," said Cheng."reference: [1] FDA grants priority review to Merck's supplementary biology license application for keytruda? (pembrolizumab) for second line treatment of patients with relieved or refractory classic Hodgkin lymphama. Retrieved July 10, 2020, Note: the purpose of this article is to introduce the progress of medical and health research, not to recommend treatment options.if you need guidance on treatment plan, please go to a regular hospital.
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