{"id":2180,"date":"2017-06-20T16:31:00","date_gmt":"2017-06-20T11:01:00","guid":{"rendered":"https:\/\/www.delveinsight.com\/blog\/?p=2180"},"modified":"2021-07-24T12:56:47","modified_gmt":"2021-07-24T07:26:47","slug":"notizia-44","status":"publish","type":"post","link":"https:\/\/www.delveinsight.com\/blog\/notizia-44","title":{"rendered":"J&#038;J nabs; Clovis plots Rubraca; Novartis scores EU approval; Seattle Genetics stops trials"},"content":{"rendered":"<div id=\"ez-toc-container\" class=\"ez-toc-v2_0_76 counter-hierarchy ez-toc-counter ez-toc-white ez-toc-container-direction\">\n<p class=\"ez-toc-title\" style=\"cursor:inherit\">Table of Contents<\/p>\n<label for=\"ez-toc-cssicon-toggle-item-6a0dbbd3de350\" class=\"ez-toc-cssicon-toggle-label\"><span class=\"\"><span class=\"eztoc-hide\" style=\"display:none;\">Toggle<\/span><span class=\"ez-toc-icon-toggle-span\"><svg style=\"fill: #999;color:#999\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" class=\"list-377408\" width=\"20px\" height=\"20px\" viewBox=\"0 0 24 24\" fill=\"none\"><path d=\"M6 6H4v2h2V6zm14 0H8v2h12V6zM4 11h2v2H4v-2zm16 0H8v2h12v-2zM4 16h2v2H4v-2zm16 0H8v2h12v-2z\" fill=\"currentColor\"><\/path><\/svg><svg style=\"fill: #999;color:#999\" class=\"arrow-unsorted-368013\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" width=\"10px\" height=\"10px\" viewBox=\"0 0 24 24\" version=\"1.2\" baseProfile=\"tiny\"><path d=\"M18.2 9.3l-6.2-6.3-6.2 6.3c-.2.2-.3.4-.3.7s.1.5.3.7c.2.2.4.3.7.3h11c.3 0 .5-.1.7-.3.2-.2.3-.5.3-.7s-.1-.5-.3-.7zM5.8 14.7l6.2 6.3 6.2-6.3c.2-.2.3-.5.3-.7s-.1-.5-.3-.7c-.2-.2-.4-.3-.7-.3h-11c-.3 0-.5.1-.7.3-.2.2-.3.5-.3.7s.1.5.3.7z\"\/><\/svg><\/span><\/span><\/label><input type=\"checkbox\"  id=\"ez-toc-cssicon-toggle-item-6a0dbbd3de350\"  aria-label=\"Toggle\" \/><nav><ul class='ez-toc-list ez-toc-list-level-1 ' ><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-1\" href=\"https:\/\/www.delveinsight.com\/blog\/notizia-44\/#Johnson_Johnson_nabs_another_combo_approval_for_myeloma_star_Darzalex\" >Johnson &amp; Johnson nabs another combo approval for myeloma star Darzalex<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-2\" href=\"https:\/\/www.delveinsight.com\/blog\/notizia-44\/#Clovis_plots_Rubraca_label_expansion_with_new_phase_3_data_for_its_PARP_inhibitor\" >Clovis plots Rubraca label expansion with new phase 3 data for its PARP inhibitor<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-3\" href=\"https:\/\/www.delveinsight.com\/blog\/notizia-44\/#Novartis_scores_EU_approval_for_biosim_of_Roches_blockbuster_Rituxan\" >Novartis scores EU approval for biosim of Roche&#8217;s blockbuster Rituxan<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-4\" href=\"https:\/\/www.delveinsight.com\/blog\/notizia-44\/#Seattle_Genetics_stops_all_trials_of_33A_blood_cancer_drug_after_patient_deaths\" >Seattle Genetics stops all trials of &#8217;33A blood cancer drug after patient deaths<\/a><\/li><\/ul><\/nav><\/div>\n<h3 style=\"text-align: justify;\"><span class=\"ez-toc-section\" id=\"Johnson_Johnson_nabs_another_combo_approval_for_myeloma_star_Darzalex\"><\/span>Johnson &amp; Johnson nabs another combo approval for myeloma star Darzalex<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p style=\"text-align: justify;\">Late last year, Johnson &amp; Johnson widened Darzalex\u2019s reach with some combo approvals. And now, it\u2019s adding to that roster. The medication has snagged a green light for use in tandem with chemo drug dexamethasone and Celgene\u2019s Pomalyst for multiple myeloma patients who have already tried at least two prior therapies, including fellow Celgene med Revlimid and a proteasome inhibitor such as Takeda\u2019s Velcade, J&amp;J partner Genmab said Friday. The approval comes based on a phase 1 study that showed the Darzalex regimen could trigger a response in 59% of patients, with those responses lasting a median 13.6 months. For J&amp;J and Genmab, it\u2019s just the latest Darzalex combo to win a go-ahead from U.S. regulators. Back in November, the team snagged a thumbs up for Darzalex\u2014alongside dexamethasone and either Revlimid or Velcade\u2014as a treatment for patients who had received just one prior therapy. That regulatory win both opened up Darzalex\u2019 target population\u2014bringing in patients who tend to stay on therapy for longer\u2014and helped even the score between Darzalex and fellow myeloma newcomers Ninlaro from Takeda and Empliciti from AbbVie and Bristol-Myers Squibb, both of which already had FDA clearance in second-line cocktails.<\/p>\n<h3 style=\"text-align: justify;\"><span class=\"ez-toc-section\" id=\"Clovis_plots_Rubraca_label_expansion_with_new_phase_3_data_for_its_PARP_inhibitor\"><\/span>Clovis plots Rubraca label expansion with new phase 3 data for its PARP inhibitor<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p style=\"text-align: justify;\">Just months into the launch of its PARP inhibitor Rubraca, Clovis Oncology on Monday unveiled positive phase 3 results that the drugmaker hopes can win its ovarian cancer drug a big label expansion in its three-drug horse race with AstraZeneca\u2019s Lynparza and Tesaro\u2019s Zejula. In a phase 3 study dubbed Ariel3, Rubraca improved progression-free survival for each of three patient populations studied, meeting primary and secondary endpoints in the 564-patient trial. For the primary endpoint, investigators analyzed women with the BRCA mutation, HRD-positive patients and the entire study population. Rubraca significantly bested placebo for each of the groups. Clovis plans to submit its data to the FDA within four months, aiming for an expansion into second-line and later maintenance treatment for ovarian cancer patients. Currently, Rubraca is approved to treat ovarian cancer patients who have the BRCA gene mutation and who\u2019ve already had two or more chemotherapies.<\/p>\n<h3 style=\"text-align: justify;\"><span class=\"ez-toc-section\" id=\"Novartis_scores_EU_approval_for_biosim_of_Roches_blockbuster_Rituxan\"><\/span>Novartis scores EU approval for biosim of Roche&#8217;s blockbuster Rituxan<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p style=\"text-align: justify;\">Roche faces bad news today for its third-top selling drug Rituxan after its cross-town rival Novartis won European approval for its biosimilar. Rixathon, the copy from Novartis\u2019 Sandoz unit, was approved to treat both blood cancers, including non-Hodgkin&#8217;s lymphoma, and immunological diseases such as rheumatoid arthritis. Sandoz follows Celltrion into the market, which in February won approval of its Rituxan biosimililar, Truxima. For Novartis, Rixathon is the fourth biosimilar approved in Europe and one more step in its plan to be a dominant player in the the field. It was the first to win approval of a biosimilar in the U.S. and has plans to have 11 biosimilar regulatory filings in the can by the end of this year, including Rixathon in the U.S.<\/p>\n<h3 style=\"text-align: justify;\"><span class=\"ez-toc-section\" id=\"Seattle_Genetics_stops_all_trials_of_33A_blood_cancer_drug_after_patient_deaths\"><\/span>Seattle Genetics stops all trials of &#8217;33A blood cancer drug after patient deaths<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p style=\"text-align: justify;\">Seattle Genetics has called a halt to all clinical testing of vadastuximab talirine (SGN-CD33A) after seeing a higher rate of patient deaths with the drug in a phase 3 trial. Several earlier-stage trials of the CD33-targeting antibody-drug conjugate were halted by the FDA last December on safety concerns, mainly relating to possible liver toxicity. Now, the CASCADE registration study in acute myeloid leukemia (AML) and another phase 1\/2 study in myelodysplastic syndrome have also been stopped, leaving the program looking decidedly shaky and driving the company&#8217;s shares down more than 11% premarket. There was no evidence of liver damage in CASCADE, but a higher rate of deaths\u2014including fatal infections\u2014were seen with vadastuximab talirine compared to placebo in the study. It&#8217;s a big blow to the company as well as AML patients and their carers, particularly as data reported at the American Society of Hematology meeting last December showed a complete remission rate of 70% with the drug.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Johnson &amp; Johnson nabs another combo approval for myeloma star Darzalex Late last year, Johnson &amp; Johnson widened Darzalex\u2019s reach with some combo approvals. And now, it\u2019s adding to that roster. The medication has snagged a green light for use in tandem with chemo drug dexamethasone and Celgene\u2019s Pomalyst for multiple myeloma patients who have [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":1991,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"_editorskit_title_hidden":false,"_editorskit_reading_time":0,"_editorskit_is_block_options_detached":false,"_editorskit_block_options_position":"{}","advgb_blocks_editor_width":"","advgb_blocks_columns_visual_guide":"","footnotes":""},"categories":[32],"tags":[17543,730,423,639,941,17544,940],"industry":[17225],"therapeutic_areas":[17227,17228],"class_list":["post-2180","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-notizia","tag-blood-cancer","tag-notizia","tag-novartis","tag-pharma-news","tag-rituxan","tag-rubraca","tag-sandoz","industry-pharmaceutical","therapeutic_areas-immunological-and-autoimmune-disorders","therapeutic_areas-oncology"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v25.8 (Yoast SEO v25.8) - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>J&amp;J nabs; Clovis plots Rubraca; Novartis scores EU approval<\/title>\n<meta name=\"description\" content=\"Late last year, Johnson &amp; Johnson widened Darzalex\u2019s reach with some combo approvals. 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Recent Pharma, Healthcare and Biotech Happenings<\/a>"],"unlinked":["<span class=\"advgb-post-tax-term\">Notizia - Recent Pharma, Healthcare and Biotech Happenings<\/span>"]},"tags":{"linked":["<a href=\"https:\/\/www.delveinsight.com\/blog\/notizia\/\" class=\"advgb-post-tax-term\">Blood Cancer<\/a>","<a href=\"https:\/\/www.delveinsight.com\/blog\/notizia\/\" class=\"advgb-post-tax-term\">Notizia<\/a>","<a href=\"https:\/\/www.delveinsight.com\/blog\/notizia\/\" class=\"advgb-post-tax-term\">Novartis<\/a>","<a href=\"https:\/\/www.delveinsight.com\/blog\/notizia\/\" class=\"advgb-post-tax-term\">pharma news<\/a>","<a href=\"https:\/\/www.delveinsight.com\/blog\/notizia\/\" class=\"advgb-post-tax-term\">Rituxan<\/a>","<a href=\"https:\/\/www.delveinsight.com\/blog\/notizia\/\" class=\"advgb-post-tax-term\">Rubraca<\/a>","<a href=\"https:\/\/www.delveinsight.com\/blog\/notizia\/\" class=\"advgb-post-tax-term\">Sandoz<\/a>"],"unlinked":["<span class=\"advgb-post-tax-term\">Blood Cancer<\/span>","<span class=\"advgb-post-tax-term\">Notizia<\/span>","<span class=\"advgb-post-tax-term\">Novartis<\/span>","<span class=\"advgb-post-tax-term\">pharma news<\/span>","<span class=\"advgb-post-tax-term\">Rituxan<\/span>","<span class=\"advgb-post-tax-term\">Rubraca<\/span>","<span class=\"advgb-post-tax-term\">Sandoz<\/span>"]}},"comment_count":"0","relative_dates":{"created":"Posted 9 years ago","modified":"Updated 5 years ago"},"absolute_dates":{"created":"Posted on Jun 20, 2017","modified":"Updated on Jul 24, 2021"},"absolute_dates_time":{"created":"Posted on Jun 20, 2017 4:31 pm","modified":"Updated on Jul 24, 2021 12:56 pm"},"featured_img_caption":"","series_order":"","_links":{"self":[{"href":"https:\/\/www.delveinsight.com\/blog\/wp-json\/wp\/v2\/posts\/2180","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.delveinsight.com\/blog\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.delveinsight.com\/blog\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.delveinsight.com\/blog\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/www.delveinsight.com\/blog\/wp-json\/wp\/v2\/comments?post=2180"}],"version-history":[{"count":0,"href":"https:\/\/www.delveinsight.com\/blog\/wp-json\/wp\/v2\/posts\/2180\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.delveinsight.com\/blog\/wp-json\/wp\/v2\/media\/1991"}],"wp:attachment":[{"href":"https:\/\/www.delveinsight.com\/blog\/wp-json\/wp\/v2\/media?parent=2180"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.delveinsight.com\/blog\/wp-json\/wp\/v2\/categories?post=2180"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.delveinsight.com\/blog\/wp-json\/wp\/v2\/tags?post=2180"},{"taxonomy":"industry","embeddable":true,"href":"https:\/\/www.delveinsight.com\/blog\/wp-json\/wp\/v2\/industry?post=2180"},{"taxonomy":"therapeutic_areas","embeddable":true,"href":"https:\/\/www.delveinsight.com\/blog\/wp-json\/wp\/v2\/therapeutic_areas?post=2180"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}