{"id":2277,"date":"2023-04-30T06:49:13","date_gmt":"2023-04-30T10:49:13","guid":{"rendered":"https:\/\/ifintechworld.com\/uncategorized\/us-fda-panel-backs-restricted-use-of-astrazenecas-prostate-cancer-drug\/"},"modified":"2023-04-30T06:49:14","modified_gmt":"2023-04-30T10:49:14","slug":"us-fda-panel-backs-restricted-use-of-astrazenecas-prostate-cancer-drug","status":"publish","type":"post","link":"https:\/\/ifintechworld.com\/?p=2277","title":{"rendered":"US FDA panel backs restricted use of AstraZeneca’s prostate cancer drug"},"content":{"rendered":"
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\u00a9 Reuters. FILE PHOTO: A company logo is seen at the AstraZeneca site in Macclesfield, Britain, May 11, 2021. REUTERS\/Phil Noble<\/span>
\n<\/i>\n<\/div>\n

(Corrects typo in headline to read “prostate”, not “prostrate”)<\/p>\n

(Reuters) -A panel of U.S. Food and Drug Administration advisers on Friday voted for the restricted use of British drugmaker AztraZeneca Plc’s experimental treatment, jointly developed with Merck & Co, for a type of prostate cancer. <\/p>\n

The FDA panel voted 11-1 with one abstention, in favor of Lynparza, in combination with other medications \u2013 abiraterone and prednisone or prednisolone \u2013 as a first-line treatment for a type of treatment-resistant prostate cancer in adult patients. <\/p>\n

However, the panel recommended the approval to be limited only to patients whose tumors have a mutation in the BCRA genes, and advised against approval beyond this patient population. <\/p>\n

Its recommendation comes after Lynparza and similar class of therapies suffered a series of safety setbacks as clinical data suggested that patients do not live as long as those given chemotherapy when given as a second-line therapy. <\/p>\n

Lynparza belongs to a class of drugs called PARP inhibitors, which include Clovis Oncology <\/span><\/span> (OTC:)’s Rubraca and GSK Plc’s Zejula. <\/p>\n

They were withdrawn last year as second line of treatment for ovarian cancer patients after the FDA limited the use of PARP inhibitors and requested companies to pull the drug. <\/p>\n

Friday’s vote is based on a late-stage study, which showed Lynparza in combination significantly improved duration for which patients live without disease worsening when compared to the placebo in combination with abiraterone and prednisone\/prednisolone.<\/p>\n

Lynparza is already approved by the FDA to treat a type of breast cancer, ovarian cancer, as well as a different form of prostate cancer. <\/p>\n

The FDA while making its final decision on the use of the drug usually follows the recommendations of its expert panel but is not obligated to do so.<\/p>\n<\/div>\n

Read the full article here<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"

\u00a9 Reuters. FILE PHOTO: A company logo is seen at the AstraZeneca site in Macclesfield, Britain, May 11, 2021. REUTERS\/Phil Noble (Corrects typo in headline to read “prostate”, not “prostrate”) (Reuters) -A panel of U.S. Food and Drug Administration advisers on Friday voted for the restricted use of British drugmaker AztraZeneca Plc’s experimental treatment, jointly […]<\/p>\n","protected":false},"author":1,"featured_media":2278,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"video","meta":{"footnotes":""},"categories":[1],"tags":[83],"class_list":["post-2277","post","type-post","status-publish","format-video","has-post-thumbnail","hentry","category-uncategorized","tag-featured","post_format-post-format-video"],"yoast_head":"\nUS FDA panel backs restricted use of AstraZeneca's prostate cancer drug | iFintechWorld<\/title>\n<meta name=\"description\" content=\"\u00a9 Reuters. 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