FDA Gives CRL to J&J's BLA for Subcutaneous Rybrevant in NSCLC

Zacks12-17 21:21

Johnson & Johnson JNJ announced that the FDA has issued a complete response letter (“CRL”) to its biologics license application (“BLA”) seeking approval for the subcutaneous (“SC”) formulation of its ...

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The BLA was based on data from the phase III PALOMA-3 study and was granted Priority Review by the FDA in August.The CRL was issued as part of the FDA’s standard pre-approval inspection at a manufacturing facility.Per J&J, the CRL is not related to the product formulation or the efficacy and safety data submitted in the regulatory application. 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The BLA was based on data from the phase III PALOMA-3 study and was granted Priority Review by the FDA in August.\nThe CRL was issued as part of the FDA’s standard pre-approval inspection at a manufacturing facility.\nPer J&J, the CRL is not related to the product formulation or the efficacy and safety data submitted in the regulatory application. The regulatory body has not requested for any additional clinical studies to be conducted either.\nYear to date, shares of J&J have declined 8.3% against the industry's growth of 6.2%.\nImage Source: Zacks Investment Research\nMore Updates Related to JNJ's Rybrevant\nIn August, the FDA approved Rybrevant in combination with oral EGFR-TKI inhibitor Lazcluze (lazertinib) as a chemotherapy-free treatment for a type of lung cancer.\nFollowing the FDA decision, Rybrevant combined with Lazcluze is approved as a first-line treatment of adult patients with locally advanced or metastatic NSCLC with EGFR exon 19 deletions or exon 21 L858R substitution mutations.\nThe FDA approval was based on the data from the phase III MARIPOSA study, which evaluated the Rybrevant-Lazcluze combo against AstraZeneca’s AZN blockbuster oncology drug Tagrisso in the given patient population.\nLast month, the Committee for Medicinal Products for Human Use recommended the approval of the Rybrevant-Lazcluze combo for a similar indication.\nIn August, the European Commission approved the combination of Rybrevant and standard-of-care chemotherapy (carboplatin and pemetrexed) for treating adult patients with advanced NSCLC with EGFR ex19del or L858R mutations after failure of prior therapy, including an EGFR-TKI. This combination received the FDA’s approval for use in a similar indication in September.\nIn March, the FDA approved the combination of Rybrevant and chemotherapy (carboplatin-pemetrexed) for the first-line treatment of patients with locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations. This combination is also approved for a similar indication in the European Union.\nRybrevant is approved as a single agent for treating adults with locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations whose disease progressed on or after platinum-based chemotherapy.\nThrough these approvals, the J&J drug intends to take on AstraZeneca’s Tagrisso, which is the current standard of care for EGFR-mutated NSCLC.\nJNJ Seeks FDA Nod for Simponi in Pediatric Ulcerative Colitis\nIn a separate press release, J&J announced that it has submitted a supplemental biologics license application (sBLA) to the FDA seeking expanded use of its anti-TNF biologic medicine, Simponi (golimumab).\nThe sBLA is seeking approval of Simponi for the treatment of moderately to severely active ulcerative colitis (“UC”) in children aged two years and above. The drug is presently approved for the treatment of moderately to severely active UC in adults.\nJNJ's Zacks Rank & Key Picks\nJ&J currently carries a Zacks Rank #3 (Hold).\nSome better-ranked stocks from the biotech sector are Castle Biosciences, Inc. CSTL and Spero Therapeutics, Inc. SPRO, each sporting a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.\nIn the past 60 days, estimates for Castle Biosciences’ 2024 bottom line have moved from a loss of 58 cents to earnings of 34 cents. Loss per share estimates for 2025 have narrowed from $2.13 to $1.84 during the same time. Year to date, shares of CSTL have surged 33.4%.\nCSTL’s earnings beat estimates in each of the trailing four quarters, the average surprise being 172.72%.\nIn the past 60 days, estimates for Spero Therapeutics’ 2024 loss per share have narrowed from $1.59 to $1.29. During the same time, estimates for 2025 loss per share have narrowed from $1.54 to 79 cents. Year to date, shares of Spero Therapeutics have lost 27.2%.\nSPRO’s earnings beat estimates in two of the trailing four quarters and missed the mark on the other two occasions, delivering an average surprise of 94.42%.\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\nJohnson & Johnson (JNJ) : Free Stock Analysis Report\nSpero Therapeutics, Inc. (SPRO) : Free Stock Analysis Report\nCastle Biosciences, Inc. (CSTL) : 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":"policyRegulatory","news_rank":0,"symbols":[],"gpt_button":1},"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/2492961008"}