{"id":1469211,"date":"2026-05-07T08:00:00","date_gmt":"2026-05-07T12:00:00","guid":{"rendered":"https:\/\/www.statnews.com\/?p=1469211"},"modified":"2026-05-06T20:21:09","modified_gmt":"2026-05-07T00:21:09","slug":"fda-reconsider-rare-disease-drug-ebvallo","status":"publish","type":"post","link":"https:\/\/www.statnews.com\/2026\/05\/07\/fda-reconsider-rare-disease-drug-ebvallo\/","title":{"rendered":"FDA to reconsider treatment for rare cancer after its surprise rejection"},"content":{"rendered":"<p>Two companies developing a therapy for a rare blood cancer have reached an agreement with the Food and Drug Administration that walked back the agency\u2019s main reason for rejecting the drug in January.\u00a0<\/p>\n\n\n\n<p>Pierre Fabre Pharmaceuticals and Atara Biotherapeutics, makers of the drug called Ebvallo, said Thursday that a meeting held in late April with FDA officials ended with the agency agreeing that their already completed, single-arm clinical trial was sufficient to support a review and potential approval.\u00a0<\/p>\n\n\n\n<p>When the <a href=\"https:\/\/www.statnews.com\/2026\/02\/25\/rare-disease-drug-fda-ebvallo\/\">FDA rejected Ebvallo<\/a>, the agency said the same study was flawed and the data produced from it was \u201cinsufficient\u201d to support the drug\u2019s approval. The drug\u2019s review was conducted by the FDA\u2019s Center for Biologics Evaluation and Research, led at the time by Vinay Prasad. He departed the agency at the end of April.\u00a0<\/p>","protected":false},"excerpt":{"rendered":"<p>The companies developing Ebvallo reached an agreement with the FDA to address its main reason for rejecting the drug.<\/p>\n","protected":false},"author":263,"featured_media":1290631,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"stat_display_restriction_not_latest":false,"stat_featured_image_caption":"","stat_featured_image_nocrop":false,"stat_featured_image_focal_point":{"x":0.5,"y":0.5},"stat_article_wordmark_img":[],"stat_article_wordmark_url":"","stat_article_wordmark_height":"125px","stat_article_wordmark_enable":false,"stat_article_subheadline":"Atara and Pierre Fabre said they reached an agreement to address agency\u2019s concerns over Ebvallo","stat_paywall_restrict":true,"footnotes":"","stat_article_enhanced_byline":"Adam Feuerstein, a senior writer and biotech columnist, is the author of <a href=\"\/signup\/scorecard\/\">Adam\u2019s Biotech Scorecard<\/a>, a subscriber-only newsletter about the crossroads of drug development, business, Wall Street, and biotechnology.","stat_article_newsletter_id":"scorecard","stat_article_header_color_scheme":"","_yoast_wpseo_primary_category":3292,"stat_paywall_move_flag":0},"categories":[3292,3006,5318,8649],"tags":[2655,330,1246,294,2251,5393],"authors":[7294],"class_list":["post-1469211","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-biotech","category-breaking-news","category-pharma","category-politics","tag-biotechnology","tag-cancer","tag-drug-development","tag-fda","tag-pharmaceuticals","tag-stat-plus"],"featured_image_src":"https:\/\/www.statnews.com\/wp-content\/uploads\/2025\/03\/GettyImages-1227710555-1024x683.jpg","coauthors":[{"avatar":"<img width=\"80\" height=\"80\" src=\"https:\/\/www.statnews.com\/wp-content\/uploads\/2021\/02\/adam-f-avatar-small2-80x80.png\" class=\"avatar\" alt=\"Adam Feuerstein\" loading=\"lazy\" sizes=\"auto, (min-width: 625px) and (max-width: 767px) 719px, (min-width: 768px) and (max-width: 899px) 835px, (min-width: 900px) and (max-width: 1023px) 635px, (min-width: 1024px) and (max-width: 1199px) 803px, (min-width: 1200px) and (max-width: 1439px) 994px, (min-width: 1440px) 982px, 576px\" decoding=\"async\" srcset=\"https:\/\/www.statnews.com\/wp-content\/uploads\/2021\/02\/adam-f-avatar-small2-80x80.png 80w, https:\/\/www.statnews.com\/wp-content\/uploads\/2021\/02\/adam-f-avatar-small2-328x328.png 328w, https:\/\/www.statnews.com\/wp-content\/uploads\/2021\/02\/adam-f-avatar-small2-500x500.png 500w, https:\/\/www.statnews.com\/wp-content\/uploads\/2021\/02\/adam-f-avatar-small2-640x640.png 640w, https:\/\/www.statnews.com\/wp-content\/uploads\/2021\/02\/adam-f-avatar-small2-576x576.png 576w, https:\/\/www.statnews.com\/wp-content\/uploads\/2021\/02\/adam-f-avatar-small2-160x160.png 160w, https:\/\/www.statnews.com\/wp-content\/uploads\/2021\/02\/adam-f-avatar-small2-645x645.png 645w, https:\/\/www.statnews.com\/wp-content\/uploads\/2021\/02\/adam-f-avatar-small2.png 700w\" \/>","display_name":"Adam Feuerstein","author_page":"https:\/\/www.statnews.com\/staff\/adam-feuerstein\/","first_name":"Adam","title":"Senior Writer, Biotech","bio":"Adam Feuerstein is a senior writer and biotech columnist, reporting on the crossroads of drug development, business, Wall Street, and biotechnology. 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var(--wp--preset--color--gold-40) !important;}.has-gold-30-color{color: var(--wp--preset--color--gold-30) !important;}.has-gold-20-color{color: var(--wp--preset--color--gold-20) !important;}.has-gold-10-color{color: var(--wp--preset--color--gold-10) !important;}.has-skin-70-color{color: var(--wp--preset--color--skin-70) !important;}.has-skin-60-color{color: var(--wp--preset--color--skin-60) !important;}.has-skin-50-color{color: var(--wp--preset--color--skin-50) !important;}.has-skin-40-color{color: var(--wp--preset--color--skin-40) !important;}.has-skin-30-color{color: var(--wp--preset--color--skin-30) !important;}.has-skin-20-color{color: var(--wp--preset--color--skin-20) !important;}.has-skin-10-color{color: var(--wp--preset--color--skin-10) !important;}.has-black-background-color{background-color: var(--wp--preset--color--black) !important;}.has-cyan-bluish-gray-background-color{background-color: var(--wp--preset--color--cyan-bluish-gray) !important;}.has-white-background-color{background-color: var(--wp--preset--color--white) !important;}.has-pale-pink-background-color{background-color: var(--wp--preset--color--pale-pink) !important;}.has-vivid-red-background-color{background-color: var(--wp--preset--color--vivid-red) !important;}.has-luminous-vivid-orange-background-color{background-color: var(--wp--preset--color--luminous-vivid-orange) !important;}.has-luminous-vivid-amber-background-color{background-color: var(--wp--preset--color--luminous-vivid-amber) !important;}.has-light-green-cyan-background-color{background-color: var(--wp--preset--color--light-green-cyan) !important;}.has-vivid-green-cyan-background-color{background-color: var(--wp--preset--color--vivid-green-cyan) !important;}.has-pale-cyan-blue-background-color{background-color: var(--wp--preset--color--pale-cyan-blue) !important;}.has-vivid-cyan-blue-background-color{background-color: var(--wp--preset--color--vivid-cyan-blue) !important;}.has-vivid-purple-background-color{background-color: var(--wp--preset--color--vivid-purple) !important;}.has-teal-50-background-color{background-color: var(--wp--preset--color--teal-50) !important;}.has-grey-10-background-color{background-color: var(--wp--preset--color--grey-10) !important;}.has-grey-80-background-color{background-color: var(--wp--preset--color--grey-80) !important;}.has-grey-40-background-color{background-color: var(--wp--preset--color--grey-40) !important;}.has-teal-10-background-color{background-color: var(--wp--preset--color--teal-10) !important;}.has-blue-70-background-color{background-color: var(--wp--preset--color--blue-70) !important;}.has-blue-60-background-color{background-color: var(--wp--preset--color--blue-60) !important;}.has-blue-50-background-color{background-color: var(--wp--preset--color--blue-50) !important;}.has-blue-40-background-color{background-color: var(--wp--preset--color--blue-40) !important;}.has-blue-30-background-color{background-color: var(--wp--preset--color--blue-30) !important;}.has-blue-20-background-color{background-color: var(--wp--preset--color--blue-20) !important;}.has-blue-10-background-color{background-color: var(--wp--preset--color--blue-10) !important;}.has-teal-70-background-color{background-color: var(--wp--preset--color--teal-70) !important;}.has-teal-60-background-color{background-color: var(--wp--preset--color--teal-60) !important;}.has-teal-40-background-color{background-color: var(--wp--preset--color--teal-40) !important;}.has-teal-30-background-color{background-color: var(--wp--preset--color--teal-30) !important;}.has-teal-20-background-color{background-color: var(--wp--preset--color--teal-20) !important;}.has-forest-70-background-color{background-color: var(--wp--preset--color--forest-70) !important;}.has-forest-60-background-color{background-color: var(--wp--preset--color--forest-60) !important;}.has-forest-50-background-color{background-color: var(--wp--preset--color--forest-50) !important;}.has-forest-40-background-color{background-color: var(--wp--preset--color--forest-40) !important;}.has-forest-30-background-color{background-color: var(--wp--preset--color--forest-30) !important;}.has-forest-20-background-color{background-color: var(--wp--preset--color--forest-20) !important;}.has-forest-10-background-color{background-color: var(--wp--preset--color--forest-10) !important;}.has-green-70-background-color{background-color: var(--wp--preset--color--green-70) !important;}.has-green-60-background-color{background-color: var(--wp--preset--color--green-60) !important;}.has-green-50-background-color{background-color: var(--wp--preset--color--green-50) !important;}.has-green-40-background-color{background-color: var(--wp--preset--color--green-40) !important;}.has-green-30-background-color{background-color: var(--wp--preset--color--green-30) !important;}.has-green-20-background-color{background-color: var(--wp--preset--color--green-20) !important;}.has-green-10-background-color{background-color: var(--wp--preset--color--green-10) !important;}.has-lime-70-background-color{background-color: var(--wp--preset--color--lime-70) !important;}.has-lime-60-background-color{background-color: var(--wp--preset--color--lime-60) !important;}.has-lime-50-background-color{background-color: var(--wp--preset--color--lime-50) !important;}.has-lime-40-background-color{background-color: var(--wp--preset--color--lime-40) !important;}.has-lime-30-background-color{background-color: var(--wp--preset--color--lime-30) !important;}.has-lime-20-background-color{background-color: var(--wp--preset--color--lime-20) !important;}.has-lime-10-background-color{background-color: var(--wp--preset--color--lime-10) !important;}.has-yellow-70-background-color{background-color: var(--wp--preset--color--yellow-70) !important;}.has-yellow-60-background-color{background-color: var(--wp--preset--color--yellow-60) !important;}.has-yellow-50-background-color{background-color: var(--wp--preset--color--yellow-50) !important;}.has-yellow-40-background-color{background-color: var(--wp--preset--color--yellow-40) !important;}.has-yellow-30-background-color{background-color: var(--wp--preset--color--yellow-30) !important;}.has-yellow-20-background-color{background-color: var(--wp--preset--color--yellow-20) !important;}.has-yellow-10-background-color{background-color: var(--wp--preset--color--yellow-10) !important;}.has-peach-70-background-color{background-color: var(--wp--preset--color--peach-70) !important;}.has-peach-60-background-color{background-color: var(--wp--preset--color--peach-60) !important;}.has-peach-50-background-color{background-color: var(--wp--preset--color--peach-50) !important;}.has-peach-40-background-color{background-color: var(--wp--preset--color--peach-40) !important;}.has-peach-30-background-color{background-color: var(--wp--preset--color--peach-30) !important;}.has-peach-20-background-color{background-color: var(--wp--preset--color--peach-20) !important;}.has-peach-10-background-color{background-color: var(--wp--preset--color--peach-10) !important;}.has-plum-70-background-color{background-color: var(--wp--preset--color--plum-70) !important;}.has-plum-60-background-color{background-color: var(--wp--preset--color--plum-60) !important;}.has-plum-50-background-color{background-color: var(--wp--preset--color--plum-50) !important;}.has-plum-40-background-color{background-color: var(--wp--preset--color--plum-40) !important;}.has-plum-30-background-color{background-color: var(--wp--preset--color--plum-30) !important;}.has-plum-20-background-color{background-color: var(--wp--preset--color--plum-20) !important;}.has-plum-10-background-color{background-color: var(--wp--preset--color--plum-10) !important;}.has-grey-70-background-color{background-color: var(--wp--preset--color--grey-70) !important;}.has-grey-60-background-color{background-color: var(--wp--preset--color--grey-60) !important;}.has-grey-50-background-color{background-color: var(--wp--preset--color--grey-50) !important;}.has-grey-30-background-color{background-color: var(--wp--preset--color--grey-30) !important;}.has-grey-20-background-color{background-color: var(--wp--preset--color--grey-20) !important;}.has-beige-70-background-color{background-color: var(--wp--preset--color--beige-70) !important;}.has-beige-60-background-color{background-color: var(--wp--preset--color--beige-60) !important;}.has-beige-50-background-color{background-color: var(--wp--preset--color--beige-50) !important;}.has-beige-40-background-color{background-color: var(--wp--preset--color--beige-40) !important;}.has-beige-30-background-color{background-color: var(--wp--preset--color--beige-30) !important;}.has-beige-20-background-color{background-color: var(--wp--preset--color--beige-20) !important;}.has-beige-10-background-color{background-color: var(--wp--preset--color--beige-10) !important;}.has-gold-70-background-color{background-color: var(--wp--preset--color--gold-70) !important;}.has-gold-60-background-color{background-color: var(--wp--preset--color--gold-60) !important;}.has-gold-50-background-color{background-color: var(--wp--preset--color--gold-50) !important;}.has-gold-40-background-color{background-color: var(--wp--preset--color--gold-40) !important;}.has-gold-30-background-color{background-color: var(--wp--preset--color--gold-30) !important;}.has-gold-20-background-color{background-color: var(--wp--preset--color--gold-20) !important;}.has-gold-10-background-color{background-color: var(--wp--preset--color--gold-10) !important;}.has-skin-70-background-color{background-color: var(--wp--preset--color--skin-70) !important;}.has-skin-60-background-color{background-color: var(--wp--preset--color--skin-60) !important;}.has-skin-50-background-color{background-color: var(--wp--preset--color--skin-50) !important;}.has-skin-40-background-color{background-color: var(--wp--preset--color--skin-40) !important;}.has-skin-30-background-color{background-color: var(--wp--preset--color--skin-30) !important;}.has-skin-20-background-color{background-color: var(--wp--preset--color--skin-20) !important;}.has-skin-10-background-color{background-color: var(--wp--preset--color--skin-10) !important;}.has-black-border-color{border-color: var(--wp--preset--color--black) !important;}.has-cyan-bluish-gray-border-color{border-color: var(--wp--preset--color--cyan-bluish-gray) !important;}.has-white-border-color{border-color: var(--wp--preset--color--white) !important;}.has-pale-pink-border-color{border-color: var(--wp--preset--color--pale-pink) !important;}.has-vivid-red-border-color{border-color: var(--wp--preset--color--vivid-red) !important;}.has-luminous-vivid-orange-border-color{border-color: var(--wp--preset--color--luminous-vivid-orange) !important;}.has-luminous-vivid-amber-border-color{border-color: var(--wp--preset--color--luminous-vivid-amber) !important;}.has-light-green-cyan-border-color{border-color: var(--wp--preset--color--light-green-cyan) !important;}.has-vivid-green-cyan-border-color{border-color: var(--wp--preset--color--vivid-green-cyan) !important;}.has-pale-cyan-blue-border-color{border-color: var(--wp--preset--color--pale-cyan-blue) !important;}.has-vivid-cyan-blue-border-color{border-color: var(--wp--preset--color--vivid-cyan-blue) !important;}.has-vivid-purple-border-color{border-color: var(--wp--preset--color--vivid-purple) !important;}.has-teal-50-border-color{border-color: var(--wp--preset--color--teal-50) !important;}.has-grey-10-border-color{border-color: var(--wp--preset--color--grey-10) !important;}.has-grey-80-border-color{border-color: var(--wp--preset--color--grey-80) !important;}.has-grey-40-border-color{border-color: var(--wp--preset--color--grey-40) !important;}.has-teal-10-border-color{border-color: var(--wp--preset--color--teal-10) !important;}.has-blue-70-border-color{border-color: var(--wp--preset--color--blue-70) !important;}.has-blue-60-border-color{border-color: var(--wp--preset--color--blue-60) !important;}.has-blue-50-border-color{border-color: var(--wp--preset--color--blue-50) !important;}.has-blue-40-border-color{border-color: var(--wp--preset--color--blue-40) !important;}.has-blue-30-border-color{border-color: var(--wp--preset--color--blue-30) !important;}.has-blue-20-border-color{border-color: var(--wp--preset--color--blue-20) !important;}.has-blue-10-border-color{border-color: var(--wp--preset--color--blue-10) !important;}.has-teal-70-border-color{border-color: var(--wp--preset--color--teal-70) !important;}.has-teal-60-border-color{border-color: var(--wp--preset--color--teal-60) !important;}.has-teal-40-border-color{border-color: var(--wp--preset--color--teal-40) !important;}.has-teal-30-border-color{border-color: var(--wp--preset--color--teal-30) !important;}.has-teal-20-border-color{border-color: var(--wp--preset--color--teal-20) !important;}.has-forest-70-border-color{border-color: var(--wp--preset--color--forest-70) !important;}.has-forest-60-border-color{border-color: var(--wp--preset--color--forest-60) !important;}.has-forest-50-border-color{border-color: var(--wp--preset--color--forest-50) !important;}.has-forest-40-border-color{border-color: var(--wp--preset--color--forest-40) !important;}.has-forest-30-border-color{border-color: var(--wp--preset--color--forest-30) !important;}.has-forest-20-border-color{border-color: var(--wp--preset--color--forest-20) !important;}.has-forest-10-border-color{border-color: var(--wp--preset--color--forest-10) !important;}.has-green-70-border-color{border-color: var(--wp--preset--color--green-70) !important;}.has-green-60-border-color{border-color: var(--wp--preset--color--green-60) !important;}.has-green-50-border-color{border-color: var(--wp--preset--color--green-50) !important;}.has-green-40-border-color{border-color: var(--wp--preset--color--green-40) !important;}.has-green-30-border-color{border-color: var(--wp--preset--color--green-30) !important;}.has-green-20-border-color{border-color: var(--wp--preset--color--green-20) !important;}.has-green-10-border-color{border-color: var(--wp--preset--color--green-10) !important;}.has-lime-70-border-color{border-color: var(--wp--preset--color--lime-70) !important;}.has-lime-60-border-color{border-color: var(--wp--preset--color--lime-60) !important;}.has-lime-50-border-color{border-color: var(--wp--preset--color--lime-50) !important;}.has-lime-40-border-color{border-color: var(--wp--preset--color--lime-40) !important;}.has-lime-30-border-color{border-color: var(--wp--preset--color--lime-30) !important;}.has-lime-20-border-color{border-color: var(--wp--preset--color--lime-20) !important;}.has-lime-10-border-color{border-color: var(--wp--preset--color--lime-10) !important;}.has-yellow-70-border-color{border-color: var(--wp--preset--color--yellow-70) !important;}.has-yellow-60-border-color{border-color: var(--wp--preset--color--yellow-60) !important;}.has-yellow-50-border-color{border-color: var(--wp--preset--color--yellow-50) !important;}.has-yellow-40-border-color{border-color: var(--wp--preset--color--yellow-40) !important;}.has-yellow-30-border-color{border-color: var(--wp--preset--color--yellow-30) !important;}.has-yellow-20-border-color{border-color: var(--wp--preset--color--yellow-20) !important;}.has-yellow-10-border-color{border-color: var(--wp--preset--color--yellow-10) !important;}.has-peach-70-border-color{border-color: var(--wp--preset--color--peach-70) !important;}.has-peach-60-border-color{border-color: var(--wp--preset--color--peach-60) !important;}.has-peach-50-border-color{border-color: var(--wp--preset--color--peach-50) !important;}.has-peach-40-border-color{border-color: var(--wp--preset--color--peach-40) !important;}.has-peach-30-border-color{border-color: var(--wp--preset--color--peach-30) !important;}.has-peach-20-border-color{border-color: var(--wp--preset--color--peach-20) !important;}.has-peach-10-border-color{border-color: var(--wp--preset--color--peach-10) !important;}.has-plum-70-border-color{border-color: var(--wp--preset--color--plum-70) !important;}.has-plum-60-border-color{border-color: var(--wp--preset--color--plum-60) !important;}.has-plum-50-border-color{border-color: var(--wp--preset--color--plum-50) !important;}.has-plum-40-border-color{border-color: var(--wp--preset--color--plum-40) !important;}.has-plum-30-border-color{border-color: var(--wp--preset--color--plum-30) !important;}.has-plum-20-border-color{border-color: var(--wp--preset--color--plum-20) !important;}.has-plum-10-border-color{border-color: var(--wp--preset--color--plum-10) !important;}.has-grey-70-border-color{border-color: var(--wp--preset--color--grey-70) !important;}.has-grey-60-border-color{border-color: var(--wp--preset--color--grey-60) !important;}.has-grey-50-border-color{border-color: var(--wp--preset--color--grey-50) !important;}.has-grey-30-border-color{border-color: var(--wp--preset--color--grey-30) !important;}.has-grey-20-border-color{border-color: var(--wp--preset--color--grey-20) !important;}.has-beige-70-border-color{border-color: var(--wp--preset--color--beige-70) !important;}.has-beige-60-border-color{border-color: var(--wp--preset--color--beige-60) !important;}.has-beige-50-border-color{border-color: var(--wp--preset--color--beige-50) !important;}.has-beige-40-border-color{border-color: var(--wp--preset--color--beige-40) !important;}.has-beige-30-border-color{border-color: var(--wp--preset--color--beige-30) !important;}.has-beige-20-border-color{border-color: var(--wp--preset--color--beige-20) !important;}.has-beige-10-border-color{border-color: var(--wp--preset--color--beige-10) !important;}.has-gold-70-border-color{border-color: var(--wp--preset--color--gold-70) !important;}.has-gold-60-border-color{border-color: var(--wp--preset--color--gold-60) !important;}.has-gold-50-border-color{border-color: var(--wp--preset--color--gold-50) !important;}.has-gold-40-border-color{border-color: var(--wp--preset--color--gold-40) !important;}.has-gold-30-border-color{border-color: var(--wp--preset--color--gold-30) !important;}.has-gold-20-border-color{border-color: var(--wp--preset--color--gold-20) !important;}.has-gold-10-border-color{border-color: var(--wp--preset--color--gold-10) !important;}.has-skin-70-border-color{border-color: var(--wp--preset--color--skin-70) !important;}.has-skin-60-border-color{border-color: var(--wp--preset--color--skin-60) 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