AZN, Daiichi's ADC Gets FDA Breakthrough Tag for EGFR-Mutated NSCLC

Zacks12-10

AstraZeneca AZN and its Japanese partner Daiichi Sankyo announced that the FDA has granted a Breakthrough Therapy designation (BTD) to their antibody-drug conjugate (ADC), datopotamab deruxtecan (Dato...

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This marks the first BTD for Dato-DXd for any indication.\nYear to date, shares of AstraZeneca have inched up 1.8% compared with the industry’s rise of 9.5%.\nImage Source: Zacks Investment Research\nBTD for Dato-DXd Based on AZN’s TROPION-Lung05 Study\nThe FDA’s BTD for Dato-DXd was based on data from the phase II TROPION-Lung05 study and supported by data from the phase III TROPION-Lung01 study.\nBased on the same data, last month, AstraZeneca and Daiichi Sankyo submitted a new biologics license application (BLA) seeking accelerated approval of Dato-DXd for previously treated advanced EGFR-mutated NSCLC.\nThe companies also voluntarily withdrew their earlier BLA seeking approval of Dato-DXd for the broader advanced or metastatic nonsquamous NSCLC based on data from the phase III TROPION-Lung01 study.\nThe decision to withdraw the BLA for nonsquamous NSCLC and instead submit one for EGFR-mutated NSCLC was based on feedback from the FDA.\nAZN & Daiichi's Dato-DXd for Breast Cancer\nAstraZeneca and Daiichi Sankyo are also seeking approval of Dato-DXd for unresectable or metastatic HR+ HER2- breast cancer. A BLA for this breast cancer indication is currently under review in the United States based on data from the TROPION-Breast01 phase III study. A decision from the FDA is expected in the first quarter of 2025.\nAstraZeneca and Daiichi have separate studies ongoing for Dato-DXd for triple-negative or HR-low, HER2-negative breast cancers.\nRegulatory applications for Dato-DXd in lung and breast cancer are underway in several other countries, including the EU, China and Japan.\nOther Companies Making ADC Drugs\nADCs like Dato-DXd are being considered a disruptive innovation in the pharmaceutical industry as these have the potential to enable better treatment of cancer by harnessing the targeting power of antibodies to deliver cytotoxic molecule drugs to tumors.\nDaiichi Sankyo has six ADCs in clinical development across multiple types of cancers, being developed utilizing its DXd ADC technology. In addition to Dato-DXd, Daiichi markets Enhertu, a HER2-directed ADC for HER2-mutated breast, lung and gastric cancers, in partnership with AstraZeneca.\nDaiichi and Merck MRK are co-developing and co-commercializing three ADCs — patritumab deruxtecan/MK-1022, raludotatug deruxtecan/MK-5909 and ifinatamab deruxtecan/MK-2400.\nWhile raludotatug deruxtecan is being developed in phase II/III study for ovarian cancer, ifinatamab deruxtecan is being studied for small-cell lung cancer in phase III and colorectal, bladder, endometrial and head and neck cancers in phase II.\nThe FDA has issued a complete response letter to Merck/Daiichi’s BLA seeking accelerated approval for patritumab deruxtecan in previously treated EGFR-mutated NSCLC.\nPfizer PFE also has a strong portfolio of ADC drugs, which were added with the acquisition of cancer biotech, Seagen. The December 2023 acquisition of Seagen added four ADCs — Adcetris, Padcev, Tukysa and Tivdak — to Pfizer’s portfolio.\nAdcetris, Padcev, Tukysa and Tivdak contributed $268 million, $409 million, $124 million and $34 million, respectively, to Pfizer’s oncology revenues in the third quarter.\nAZN's Zacks Rank\nAstraZeneca currently has a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.\nWant the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report\nAstraZeneca PLC (AZN) : Free Stock Analysis Report\nPfizer Inc. (PFE) : Free Stock Analysis Report\nMerck & Co., Inc. (MRK) : Free Stock Analysis Report\nTo read this article on Zacks.com click here.\nZacks Investment Research","kind":"highlight","is_publish_news":true,"is_publish_highlight":false,"is_publish_live":false,"is_publish_wemedia":null,"editions":null,"column":"","sentiment":"1","news_tag":"productRelease","news_rank":0,"symbols":[],"gpt_button":0},"commentList":[],"isCommentEnd":true,"newsSizeData":{"likeSize":0,"commentSize":0,"repostSize":0,"favoriteSize":0,"likeStatus":false,"favoriteStatus":false},"APP":{"userAgent":"Mozilla/5.0 AppleWebKit/537.36 (KHTML, like Gecko; compatible; ClaudeBot/1.0; +claudebot@anthropic.com)","isDev":false,"isTTM":true,"deviceId":"web-server-community-laohu8-v3","version":"4.29.3","shortVersion":"4.29.3","platform":"web","vendor":"web","appName":"ttm","isIOS":false,"isAndroid":false,"isTiger":false,"isTHS":false,"isWeiXin":false,"isWeiXinMini":false,"isWeiBo":false,"isQQ":false,"isBaiduSwan":false,"isBaiduBox":false,"isDingTalk":false,"isToutiao":false,"isOnePlus":false,"isHuaWei":false,"isXiaomi":false,"isXiaomiWebView":false,"isOppo":false,"isVivo":false,"isSamsung":false,"isMobile":false},"href":"/m/news/2490048967"}