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FDA接受明星公司Loxo的明星藥物Larotrectinib的上市申請,並授予優先審評資格!

時間:2018-05-30    作者:聯創生物醫藥信息部

最新消息!

美國Loxo腫瘤學(Loxo Oncology)公司是一家知名度與日俱增的生物制藥公司,是2017 ASCO大會上冉冉升起的一顆明星,旨在爲患有遺傳缺陷的癌症患者開發高選擇性創新藥物。該公司于2018529日宣布,FDA已經接受了其在研藥物larotrectinib的新藥申請(NDA)並授予了優先審評資格,該藥物用于治療患有NTRK基因融合的晚期或轉移性實體瘤的成人和兒童患者。根據處方藥使用者費用法PDUFA),FDA已經將目標批准日期設定爲20181126日。 

 

Loxo Oncology首席執行官Josh Bilenker博士表示:“我們很高興larotrectinib的NDA已被FDA接受並獲得優先審評資格。Larotrectinib標志著治療癌症方面的一個重要轉變,癌症治療將基于腫瘤的遺傳學特征,而不再是癌症在體內的起源部位。”

除了優先審評資格之外,Larotrectinib也獲得了FDA授予的突破性療法認定、罕見兒科疾病認定和孤兒藥資格。

2017年冉冉升起的8個ASCO明星藥物!

權威發布!針對17種腫瘤的傳奇抗癌藥LOXO-101最新研究數據公布!有效率75%!

Loxo公司和拜耳公司正在開展larotrectinib的開發和商業化合作。拜耳計劃于2018年向歐盟提交上市申請(MAA)。

 

如果獲批,Larotrectinib將成爲首款不區分腫瘤來源的小分子抗癌藥物,具有劃時代意義。2017年5月23日,美國FDA傳來一條重量級消息——由默沙東(MSD)帶來的KEYTRUDA(pembrolizumab)獲批治療帶有微衛星不穩定性高(microsatellite instability-high,MSI-H)或錯配修複缺陷(mismatch repair deficient,dMMR)的實體瘤患者,他們的病情在先前的治療後都出現了進展。值得一提的是,這是美國FDA批准的首款不依照腫瘤來源,而是依照生物標志物進行區分的抗腫瘤療法,具有裏程碑式的意義。

劃時代!FDA今日加速批准首款不區分腫瘤來源的抗癌療法

請閱讀新聞稿了解詳情。藥時代將繼續密切關注,及時報道。

FDA Accepts Larotrectinib New Drug Application and Grants Priority Review

GlobeNewswire May 29, 2018

– PDUFA date set for November 26, 2018 –

STAMFORD, Conn., May 29, 2018 (GLOBE NEWSWIRE) -- Loxo Oncology, Inc. (LOXO), a biopharmaceutical company innovating the development of highly selective medicines for patients with genetically defined cancers, today announced that the U.S. Food and Drug Administration (FDA) has accepted the company’s New Drug Application (NDA) and granted Priority Review for larotrectinib for the treatment of adult and pediatric patients with locally advanced or metastatic solid tumors harboring an NTRK gene fusion. The FDA has set a target action date of November 26, 2018, under the Prescription Drug User Fee Act (PDUFA).

“We are excited the larotrectinib NDA has been accepted by FDA and granted Priority Review status,” said Josh Bilenker, M.D., chief executive officer of Loxo Oncology. “Larotrectinib marks an important shift towards treating cancer based on the tumor’s genetics rather than its site of origin in the body.”

The FDA grants Priority Review for the applications of medicines that, if approved, would provide significant improvements in the safety or effectiveness of the treatment, diagnosis, or prevention of serious conditions when compared to standard applications. Larotrectinib has also been granted Breakthrough Therapy Designation, Rare Pediatric Disease Designation and Orphan Drug Designation by the FDA.

Loxo Oncology and Bayer are engaged in a collaboration for the development and commercialization of larotrectinib. Bayer plans to submit a Marketing Authorization Application (MAA) in the European Union in 2018.

About Larotrectinib (LOXO-101)
Larotrectinib is an oral and highly selective investigational tropomyosin receptor kinase (TRK) inhibitor in clinical development for the treatment of patients with cancers that harbor a neurotrophic tyrosine receptor kinase (NTRK) gene fusion. Growing research suggests that the NTRK genes, which encode for TRKs, can become abnormally fused to other genes, resulting in growth signals that can lead to cancer in many sites of the body. In clinical trials, larotrectinib demonstrated anti-tumor activity in patients with tumors harboring NTRK gene fusions, regardless of patient age or tumor type. In an analysis of 55 RECIST-evaluable adult and pediatric patients with NTRK gene fusions, larotrectinib demonstrated a 75 percent centrally-assessed confirmed overall response rate (ORR) and an 80 percent investigator-assessed confirmed ORR, across many different types of solid tumors. The majority of all adverse events were grade 1 or 2.

Larotrectinib has been granted Priority Review, Breakthrough Therapy Designation, Rare Pediatric Disease Designation and Orphan Drug Designation by the U.S. FDA.

In November 2017, Loxo Oncology and Bayer entered into an exclusive global collaboration for the development and commercialization of larotrectinib and LOXO-195, a next-generation TRK inhibitor. Bayer and Loxo Oncology will jointly develop the two products with Loxo Oncology leading the ongoing clinical studies as well as the filing in the U.S., and Bayer leading ex-U.S. regulatory activities and worldwide commercial activities. In the U.S., Loxo Oncology and Bayer will co-promote the products.

For additional information about the larotrectinib clinical trials, please refer to www.clinicaltrials.gov. Interested patients and physicians can contact the Loxo Oncology Physician and Patient Clinical Trial Hotline at 1-855-NTRK-123 or visit www.loxooncologytrials.com/trk-trials.

About TRK Fusion Cancer
TRK fusion cancer occurs when a neurotrophic tyrosine receptor kinase (NTRK) gene fuses with another unrelated gene, producing an altered tropomyosin receptor kinase (TRK) protein. The altered protein, or TRK fusion protein, is constantly active, triggering a permanent signal cascade. These proteins become the primary driver of the spread and growth of tumors in patients with TRK fusion cancer. TRK fusion cancer is not limited to certain types of cells or tissues and can occur in any part of the body. NTRK gene fusions occur in various adult and pediatric solid tumors with varying prevalence, including appendiceal cancer, breast cancer, cholangiocarcinoma, colorectal cancer, GIST, infantile fibrosarcoma, lung cancer, mammary analogue secretory carcinoma of the salivary gland, melanoma, pancreatic cancer, thyroid cancer, and various sarcomas. It may affect greater than 60 percent of both adult and pediatric patients with certain rare tumor types, such as secretory breast, secretory salivary gland and infantile fibrosarcoma. Only sensitive and specific tests can reliably detect TRK fusion cancer. Next-generation sequencing (NGS) can provide a comprehensive view of genomic alterations across a large number of genes. Fluorescence in situ hybridization (FISH) can also be used to test for TRK fusion cancer, and immunohistochemistry (IHC) can be used to detect the presence of TRK protein

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