Repotrectinib was also granted an Orphan Drug designation in 2017. Repotrectinib was recently granted Breakthrough Therapy designation for the treatment of patients with advanced solid tumors that have an NTRK gene fusion who have progressed following treatment . ¹ Estimates rounded and include locally advanced and metastatic populations per SEER, based on incidence reported by American Cancer Society Cancer Facts . The FDA has granted a breakthrough therapy designation to repotrectinib (TPX-0005) for the treatment of patients with NRTK -positive, (Tyrosine kinase inhibitor) TKI-pretreated advanced solid tumors, according to a press release by ZaiLab. Repotrectinib is a small (low molecular weight), macrocyclic tyrosine kinase inhibitor of ROS1, TRK, and ALK. About Repotrectinib. SHANGHAI, China and SAN FRANCISCO, Oct 04, 2021 (GLOBE NEWSWIRE via COMTEX) -- SHANGHAI, China and SAN FRANCISCO, Oct. 04, 2021 (GLOBE NEWSWIRE) -- Zai Lab. China-based Zai Lab and Turning Point Therapeutics announced that the FDA has granted a breakthrough therapy designation to repotrectinib, which is the seventh regulatory designation repotrectinib got from USFDA.. Repotrectinib is a potential treatment for advanced solid tumor patients with an NTRK gene fusion. Repotrectinib's Development Designations.
9 The Real-Time Oncology Review (RTOR) pilot program aims to explore a more efficient review process that ensures safe and . The FDA has granted a breakthrough therapy designation to repotrectinib for the treatment of patients with solid tumors harboring an NTRK gene fusion who experienced progression after being treated with 1 to 2 previous TRK tyrosine kinase inhibitors (TKIs) plus or minus chemotherapy and who have no other treatment options, according to a press release from developer Turning Point Therapeutics.1 预估将在2022年上半年度与FDA举办的B类大会上，开展申请注册repotrectinib的下一步对策。该融入症状的准许意味着repotrectinib的第七个管控特定。 先前，该药品曾被授于ROS1呈阳性迁移扩散性非小细胞肺癌（以往未应用过靶向治疗ROS1的TKI开展医治）的开创性医治头衔。 Abbreviation: SUL-DUR (Sulbactam-Durlobactam). FDA has granted another set of regulatory privileges under its breakthrough devices program. In addition, the FDA has granted repotrectinib orphan drug designation for the treatment of advanced NSCLC with adenocarcinoma histology; and . Repotrectinib was given Breakthrough Therapy designation The company received a Breakthrough Therapy designation was given for repotrectinib in treating patients with advanced solid tumors having an NTRK gene fusion that . FDA Grants Breakthrough Therapy Designation to Repotrectinib for Solid Tumors With NTRK Gene Fusions. Pre & Post. SAN DIEGO, Oct. 04, 2021 (GLOBE NEWSWIRE) -- Turning Point Therapeutics, Inc. (NASDAQ: TPTX), a precision oncology company developing next-generation therapies that target genetic drivers of cancer, today announced the U.S. Food and Drug Administration (FDA) granted a seventh regulatory designation to lead drug candidate, repotrectinib. Retrieved October 4, 2021, from . By: JNCCN 360 Staff Posted: Tuesday, October 12, 2021. Repotrectinib was recently granted Breakthrough Therapy designation for the treatment of patients with advanced solid tumors that have an NTRK gene fusion who have progressed following treatment with one or two prior TRK tyrosine kinase inhibitors, with or without prior chemotherapy, and have no satisfactory alternative treatments. SAN DIEGO, Oct. 04, 2021 (GLOBE NEWSWIRE) -- Turning Point Therapeutics Inc. (NASDAQ: TPTX), a precision oncology company developing next-generation therapies that target genetic drivers of cancer, today announced the U.S. Food and Drug Administration (FDA) granted a seventh regulatory designation to lead drug candidate, repotrectinib. . On October 6, the U.S. Food and Drug Administration (FDA) granted BreakthroughTtherapy designation to repotrectinib for the treatment of patients with solid tumors that have an NTRK gene fusion.These patients must have experienced disease . The preliminary results from TRIDENT-1 led the FDA to grant repotrectinib a Breakthrough Therapy Designation, which may expedite the development of the drug and the regulatory review an application for FDA approval of repotrectinib as treatment of ROS1-positive metastatic NSCLC. Breakthrough Therapy (BT) Designation is an expedited review program introduced in Section 902 of the Food and Drug Safety and Innovation Act of 2012The Breakthrough Designation is granted to the drug candidates as monotherapy or in combination with other drugs intended to treat serious or life-threatening diseases and has shown substantial improvement over available therapies […] In August, Turning Point began the first cohort of its phase 1b/2 TRIDENT-2 . The Breakthrough Therapy designation is the seventh regulatory designation for repotrectinib. Bemarituzumab: Breakthrough Therapy Designations granted in both US and China Adagrasib: Breakthrough Therapy Designation granted by the FDA Repotrectinib: Breakthrough Therapy Designation granted by the FDA for NTRK+ patients TPX-0022: Fast Track Designation and Orphan Drug Designation granted by the FDA Efgartigimod: 5 CTA approvals in China Zai Lab Partner Turning Point Therapeutics Granted FDA Breakthrough Therapy Designation For Repotrectinib Treatment In Patients With NTRK-Positive, TKI-Pretreated Advanced Solid Tumors The breakthrough therapy designation for repotrectinib was supported by the initial data from TKI-naïve ROS1-positive NSCLC patients enrolled in the Phase 1 and Phase 2 portions of the TRIDENT-1 study, which is currently evaluating patients in multiple potentially registrational cohorts. The breakthrough designation comes about a year-and-a-half after it locked down its first FDA clearance in March 2020, when the agency green-lit the RefleXion X1 machine. The FDA recently granted Breakthrough Therapy designation in this population. Global Breakthrough Therapy (BT) Designation Market size USD 94060 million by 2027, from USD 53250 million in 2020, at a CAGR of 8.0% during time interval 2022 forecast till 2027. Daejeon, South Korea-based Easyendo is already working . The FDA has additionally granted Breakthrough Therapy Designation, a Special Protocol Agreement, and a Biomarker Letter of Support to NRx for NRX-101, an investigational medicine to treat suicidal bipolar depression.
SAN DIEGO, Dec. 08, 2020 (GLOBE NEWSWIRE) -- Turning Point Therapeutics, Inc. (NASDAQ: TPTX), a precision oncology company developing next-generation therapies that target genetic drivers of cancer, today announced its lead drug candidate, repotrectinib, has been granted breakthrough therapy designation by the Food and Drug Administration (FDA) for the treatment of patients with ROS1-positive . A Breakthrough Therapy designation is designed to expedite the development and regulatory review of medicines that may demonstrate substantial improvement on a clinically significant endpoint over available medicines.
About Zai Lab Zai Lab (NASDAQ: ZLAB; HKEX: 9688) is an innovative, research-based, commercial-stage biopharmaceutical company focused on developing and commercializing therapies that address medical conditions with unmet needs in oncology, autoimmune disorders and infectious . On December 8, 2020, Turning Point Therapeutics Inc., repotrectinib's developer, announced that the U.S. Food and Drug Administration had granted the agent a breakthrough therapy designation for . Note: Turning Point retains global rights to all products except for repotrectinib in Greater China. Apply online instantly. Turning Point Therapeutics said this week that the US Food and Drug Administration has granted breakthrough therapy designation to the firm's investigational agent repotrectinib for patients with advanced solid tumors harboring NTRK gene fusions. The device, currently known as Easyuretero, is the first of its type to be developed in South Korea. The breakthrough therapy designation for repotrectinib was supported by the initial data from TKI-naïve ROS1-positive NSCLC patients enrolled in the Phase 1 and Phase 2 portions of the TRIDENT-1 study, which is currently evaluating patients in multiple potentially registrational cohorts.
The breakthrough therapy designation marks the agents seventh regulatory designation.
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