FDA Rejects Johnson & Johnson's Injectable Version Of Approved Drug For Lung Cancer
FDA Rejects Johnson & Johnson's Injectable Version Of Approved Drug For Lung Cancer
The CRL is unrelated to the product formulation or the efficacy and safety data submitted in the regulatory application, and the FDA has not requested any additional clinical studies.On Monday, the U.S. Food and Drug Administration issued a complete response letter (CRL) to Johnson & Johnson's (NYSE:JNJ) Biologics License Application for a fixed combination of amivantamab and recombinant human hyaluronidase for subcutaneous administration (SC amivantamab) in patients with non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) mutations.
週一，美國食品和藥物管理局向強生（紐交所：JNJ）發出了完整答覆信（CRL），涉及其生物製品許可申請，申請內容是用於非小細胞肺癌（NSCLC）且具有表皮生長因子受體（EGFR）突變的患者進行皮下給藥的阿米萬單抗和重組人透明質酸酶的固定組合（SC阿米萬單抗）。
The CRL is related to observations as part of a standard pre-approval inspection at a manufacturing facility.
該CRL與製造設施標準預批准檢查過程中觀察到的事項相關。
Also Read: Johnson & Johnson Challenges Government Drug Pricing Dispute Over Two Drugs
另請閱讀：強生對政府藥品定價爭議發起挑戰，涉及兩種藥物。
The CRL is unrelated to the product formulation or the efficacy and safety data submitted in the regulatory application, and the FDA has not requested any additional clinical studies.
該CRL與產品配方或在監管申請中提交的療效和安全性數據無關，FDA也沒有要求任何額外的臨床研究。
The CRL does not impact the currently approved intravenous (IV) formulation of Rybrevant (amivantamab-vmjw).
該CRL不會影響目前已批准的瑞布維特（阿米萬單抗-vmjw）的靜脈注射（IV）配方。
"We're working closely with the FDA to bring SC amivantamab to patients as quickly as possible and are confident in our path to resolution," said Yusri Elsayed, Global Therapeutic Area Head, Oncology, Innovative Medicine, Johnson & Johnson.
強生的全球治療領域負責人、腫瘤學創新醫學部Yusri Elsayed表示："我們正與FDA密切合作，儘快將SC阿米萬單抗提供給患者，並對我們的解決方案充滿信心。"
"Backed by interim overall survival data showing a strong favorable trend compared to osimertinib, we believe strongly in the robust efficacy and safety of RYBREVANT — both as a standalone treatment and in combination with LAZCLUZE — for EGFR-mutated advanced lung cancer," Elsayed added.
Elsayed補充道："有臨時整體生存數據表明與奧希替尼相比具有強有利趨勢，我們堅信瑞布維特的強大療效和安全性——無論是作爲單一療法還是與LAZCLUZE聯合使用——用於EGFR突變的晚期肺癌。"
AstraZeneca Plc (NASDAQ:AZN) sells osimertinib under the Tagrisso name.
阿斯利康（納斯達克：AZN）以Tagrisso的名稱出售奧希替尼。
The BLA is based on the Phase 3 PALOMA-3 study results, presented at the 2024 American Society of Clinical Oncology Annual Meeting and published in the Journal of Clinical Oncology.
該生物製品申請基於2024年美國臨床腫瘤學會年會上發佈的第3階段PALOMA-3研究結果，並已發表在《臨床腫瘤學雜誌》上。
In August 2024, the FDA granted a Priority Review for the BLA for SC amivantamab as a treatment for patients with NSCLC with EGFR exon 19 deletions or L858R substitution mutations. RYBREVANT is currently approved in over 60 countries worldwide.
在2024年8月，FDA批准了SC amivantamab的生物製品申請的優先審查，作爲針對患有EGFR外顯子19缺失或L858R替代突變的非小細胞肺癌患者的治療。RYBREVANt目前在全球超過60個國家獲得批准。
JNJ Price Action: Johnson & Johnson stock is up 1.26% at $145.64 at last check Tuesday.
強生股價動態：截至週二最後一次檢查，強生股票上漲1.26%，報145.64美元。
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Photo: Shutterstock
Photo: shutterstock
譯文內容由第三人軟體翻譯。