{"id":28398,"date":"2023-05-01T20:49:10","date_gmt":"2023-05-01T20:49:10","guid":{"rendered":"http:\/\/lynettelockhart.com\/client\/us-fda-panel-backs\/"},"modified":"2023-05-01T20:49:52","modified_gmt":"2023-05-01T20:49:52","slug":"us-fda-panel-backs","status":"publish","type":"post","link":"http:\/\/lynettelockhart.com\/client\/us-fda-panel-backs\/","title":{"rendered":"US FDA panel backs restricted use of AstraZeneca’s prostate cancer drug (April 28)"},"content":{"rendered":"

(This April 28 story has been corrected to fix the company’s name in paragraph 1)<\/p>\n

(Reuters) – A panel of U.S. Food and Drug Administration advisers on Friday voted for the restricted use of British drugmaker AstraZeneca 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’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They were withdrawn last year as second line of treatment for ovarian cancer patients after the FDA limited the use of PARP inhibitors and requested companies to pull the drug.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

\n

(Reporting by Mariam Sunny, Khushi Mandowara and Aditya Samal in Bengaluru; Editing by Shailesh Kuber and Arun Koyyur)<\/p>\n

\"tagreuters.com2023binary_LYNXMPEJ3R10K-VIEWIMAGE\"<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"

(This April 28 story has been corrected to fix the company’s name in paragraph 1) (Reuters) – A panel of U.S. Food and Drug Administration advisers on Friday voted for the restricted use of British drugmaker AstraZeneca Plc’s experimental treatment, jointly developed with Merck & Co, for a type of prostate cancer. The FDA panel […]<\/p>\n","protected":false},"author":8,"featured_media":28399,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"spay_email":"","footnotes":""},"categories":[1214],"tags":[1223],"class_list":["post-28398","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-u-s-domestic","tag-updated"],"jetpack_featured_media_url":"http:\/\/lynettelockhart.com\/client\/wp-content\/uploads\/Reuters_Direct_Media\/USOnlineReportDomesticNews\/tagreuters.com2023binary_LYNXMPEJ3R10K-VIEWIMAGE.jpg","_links":{"self":[{"href":"http:\/\/lynettelockhart.com\/client\/wp-json\/wp\/v2\/posts\/28398","targetHints":{"allow":["GET"]}}],"collection":[{"href":"http:\/\/lynettelockhart.com\/client\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"http:\/\/lynettelockhart.com\/client\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"http:\/\/lynettelockhart.com\/client\/wp-json\/wp\/v2\/users\/8"}],"replies":[{"embeddable":true,"href":"http:\/\/lynettelockhart.com\/client\/wp-json\/wp\/v2\/comments?post=28398"}],"version-history":[{"count":7,"href":"http:\/\/lynettelockhart.com\/client\/wp-json\/wp\/v2\/posts\/28398\/revisions"}],"predecessor-version":[{"id":30044,"href":"http:\/\/lynettelockhart.com\/client\/wp-json\/wp\/v2\/posts\/28398\/revisions\/30044"}],"wp:featuredmedia":[{"embeddable":true,"href":"http:\/\/lynettelockhart.com\/client\/wp-json\/wp\/v2\/media\/28399"}],"wp:attachment":[{"href":"http:\/\/lynettelockhart.com\/client\/wp-json\/wp\/v2\/media?parent=28398"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"http:\/\/lynettelockhart.com\/client\/wp-json\/wp\/v2\/categories?post=28398"},{"taxonomy":"post_tag","embeddable":true,"href":"http:\/\/lynettelockhart.com\/client\/wp-json\/wp\/v2\/tags?post=28398"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}