TKI

QIAGEN receives FDA approval for companion diagnostic to Blueprint Medicines’ AYVAKIT® (avapritinib) in gastrointestinal stromal tumors

Retrieved on: 
Monday, August 7, 2023
TKI, GIST, DNA, QIAGEN, QGEN, Stromal cell, Gastrointestinal tract, DSM-IV codes, Research fellow, Biotechnology, NGS, Mutation, Helix, Sarcoma, PDGFRA, Patient, Physician, Polymerase chain reaction, Medicine, Nested polymerase chain reaction, MDX, FDA, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, NYSE, PCR, Food, Vaccine

The kit is the first platelet-derived growth factor receptor alpha (PDGFRA) assay to receive FDA approval as a companion diagnostic.

Key Points: 
  • The kit is the first platelet-derived growth factor receptor alpha (PDGFRA) assay to receive FDA approval as a companion diagnostic.
  • QIAGEN and Blueprint Medicines collaboratively developed the PDGFRA companion diagnostic assay.
  • QIAGEN is a pioneer in precision medicine and the leader in collaborating with pharmaceutical and biotechnology companies to develop companion diagnostics.
  • Furthermore, QIAGEN has recently announced a series of collaborations with Neuron23 and Helix to develop companion diagnostics in disease areas outside oncology.

ESMO 2023 | Ascentage Pharma to Present Results from Two Clinical Studies, including One Oral Presentation, at 2023 ESMO Congress

Retrieved on: 
Thursday, August 3, 2023
GIST, Mini, ESMO, Cancer, Hope, TKI, CHB, BCR-ABL, Oncology, NSCLC, European Society for Medical Oncology, Congress, Poster, Patient, Notifiable disease, Gastrointestinal stromal tumor, Hepatitis, Pharmaceutical industry

As one of the most authoritative and influential congresses in oncology globally, the ESMO Congress showcases the latest results from some of the most cutting-edge research from around the world.

Key Points: 
  • As one of the most authoritative and influential congresses in oncology globally, the ESMO Congress showcases the latest results from some of the most cutting-edge research from around the world.
  • This year, the ESMO Congress will take place on October 20 to October 24, local time, in Madrid, Spain.
  • "These presentations highlight Ascentage Pharma's robust capabilities in clinical development and global innovation, as well as our strong potential in solid tumors.
  • These two clinical studies to be presented at the ESMO Congress this year are as follows:

Clearside Biomedical Highlights Excellent Safety Profile of CLS-AX and Potential for Extended Duration of Effect in Data Presentation at the American Society of Retina Specialists 41st Annual Scientific Meeting

Retrieved on: 
Monday, July 31, 2023
Durability, Diabetes, Anti-VEGF, AMD, Pharming, Cohort, Aes, Eye, Clinical trial, TKI, Targeted therapy, Diabetic retinopathy, Retina, Inflammation, Extension, Șaeș, Melanoma, Patient, Physician, CST, Associate, Month, Biological effects of high-energy visible light, Vascular occlusion, Axitinib, Phase, Visual acuity, Society, ASRS, Safety, SCS, Pharmaceutical industry, MD

ALPHARETTA, Ga., July 31, 2023 (GLOBE NEWSWIRE) -- Clearside Biomedical, Inc. (Nasdaq: CLSD), a biopharmaceutical company revolutionizing the delivery of therapies to the back of the eye through the suprachoroidal space (SCS®), announced today that safety and tolerability data from its recent OASIS clinical trial of CLS-AX (axitinib injectable suspension) were presented at the American Society of Retina Specialists (ASRS) 41st Annual Scientific Meeting. CLS-AX is a proprietary suspension formulation of the tyrosine kinase inhibitor (TKI) axitinib that provides high potency pan-VEGF inhibition delivered via Clearside’s proprietary SCS Microinjector®.

Key Points: 
  • CLS-AX is a proprietary suspension formulation of the tyrosine kinase inhibitor (TKI) axitinib that provides high potency pan-VEGF inhibition delivered via Clearside’s proprietary SCS Microinjector®.
  • The presentation, entitled, “Safety and Tolerability of Suprachoroidal Injection of CLS-AX in Neovascular AMD Patients With Persistent Activity After Anti-VEGF Therapy” was delivered by Rahul N. Khurana, MD, FACRS, Northern California Retina Vitreous Associates.
  • “The safety profile for new potential treatments in development for wet AMD and other retinal diseases is of paramount importance to physicians and patients.
  • CLS-AX has demonstrated an excellent safety profile to date with no adverse events, and in particular, no inflammation,” said George Lasezkay, Pharm.D., J.D., President and Chief Executive Officer.

Elevar Therapeutics Announces Publication of Phase 3 CARES 310 Study Results in The Lancet

Retrieved on: 
Tuesday, July 25, 2023
Camrelizumab, ACC, Hepatocellular carcinoma, Progression-free survival, Food, TKI, Adenoid cystic carcinoma, Prescription Drug User Fee Act, Patient, Sorafenib, PDUFA, PD-1, FDA, Therapy, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, HCC, Pharmaceutical industry, Lancet

FORT LEE, N.J., July 24, 2023 (GLOBE NEWSWIRE) -- Elevar Therapeutics, Inc., a majority-owned subsidiary of HLB Co., Ltd. and a fully integrated biopharmaceutical company dedicated to elevating treatment experiences and outcomes for patients who have limited or inadequate therapeutic options, today announced the publication of its Phase 3 CARES 310 study results in The Lancet.

Key Points: 
  • FORT LEE, N.J., July 24, 2023 (GLOBE NEWSWIRE) -- Elevar Therapeutics, Inc., a majority-owned subsidiary of HLB Co., Ltd. and a fully integrated biopharmaceutical company dedicated to elevating treatment experiences and outcomes for patients who have limited or inadequate therapeutic options, today announced the publication of its Phase 3 CARES 310 study results in The Lancet.
  • The study assessed the combination of Elevar’s drug candidate rivoceranib, an oral TKI, in combination with camrelizumab, a PD-1 inhibitor, as a first-line therapy for unresectable hepatocellular carcinoma (uHCC).
  • “As evidenced in the CARES 310 study, camrelizumab plus rivoceranib demonstrate significant promise as a potentially improved therapy for advanced hepatocellular carcinoma,” said Saeho Chong, Elevar chief executive officer.
  • With efficacy results generally consistent across all subgroups, the CARES 310 data suggested the combination confers a benefit in a global uHCC population.

Elevar Therapeutics Announces FDA Acceptance for Filing of New Drug Application for Rivoceranib in Combination with Camrelizumab as a First-line Treatment for Unresectable Hepatocellular Carcinoma

Retrieved on: 
Monday, July 17, 2023
Hepatocellular carcinoma, Progression-free survival, NDA, TKI, PFS, Patient, Sorafenib, PDUFA, PD-1, FDA, Therapy, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Food, Pharmaceutical industry

The FDA assigned a Prescription Drug User Fee Act (PDUFA) target action date of May 16, 2024.

Key Points: 
  • The FDA assigned a Prescription Drug User Fee Act (PDUFA) target action date of May 16, 2024.
  • “Rivoceranib plus camrelizumab has demonstrated the potential to improve the lives of those confronted with unresectable hepatocellular carcinoma,” said Saeho Chong, Elevar chief executive officer.
  • “With the FDA’s acceptance of our new drug application, we are pleased to reach another milestone in the development of this combination therapy.
  • Elevar is also developing rivoceranib as a monotherapy treatment option for adenoid cystic carcinoma (ACC), and as mono and combination therapies in other tumor cell types.

Junshi Biosciences Announces Acceptance of the Supplemental New Drug Application for Toripalimab

Retrieved on: 
Wednesday, July 12, 2023
TKI, Malignancy, Renji Hospital, RCC, Clinical trial, Hope, Nephrectomy, Immunotherapy, PFS, Kidney, Shanghai Jiao Tong University School of Medicine, Global Research, Chinese, Death, Development, SSE, Chinese Medical Journal, HIV disease progression rates, Patient, Risk, National Medical Products Administration, IMDC, Carcinoma, Diagnosis, Axitinib, ORR, Safety, Disease, Pharmaceutical industry

Therefore, the need for new treatment options is more urgent for patients with medium and high-risk advanced RCC compared to low-risk patients.

Key Points: 
  • Therefore, the need for new treatment options is more urgent for patients with medium and high-risk advanced RCC compared to low-risk patients.
  • This supplemental new drug application is mainly based on the RENOTORCH study (NCT04394975).
  • The safety profile of toripalimab in the study was consistent with known risks, and no new safety signals were identified.
  • Dr. Jianjun ZOU, the Global Research and Development President of Junshi Biosciences, expressed her enthusiasm regarding the acceptance of this application.

AVEO Oncology Announces Completion of Enrollment in Pivotal Phase 3 TiNivo-2 Study of FOTIVDA® (tivozanib) in Combination with OPDIVO® (nivolumab) in Advanced Renal Cell Carcinoma

Retrieved on: 
Tuesday, June 27, 2023
Apoptosis, RCC, Bristol Myers Squibb, TKI, Immunotherapy, Harvard Medical School, NCCN, VEGF, Journal of the National Comprehensive Cancer Network, Patient, Data, LG Chem, Safety, Nivolumab, Dana–Farber Cancer Institute, Pharmaceutical industry

BOSTON, June 27, 2023 /PRNewswire/ -- AVEO Oncology, an LG Chem company, ("AVEO"), announced today that it has completed enrollment in the pivotal Phase 3 TiNivo-2 study in patients with advanced relapsed or refractory renal cell carcinoma (RCC) following prior immunotherapy exposure.

Key Points: 
  • BOSTON, June 27, 2023 /PRNewswire/ -- AVEO Oncology, an LG Chem company, ("AVEO"), announced today that it has completed enrollment in the pivotal Phase 3 TiNivo-2 study in patients with advanced relapsed or refractory renal cell carcinoma (RCC) following prior immunotherapy exposure.
  • The study is evaluating FOTIVDA® (tivozanib) in combination with OPDIVO® (nivolumab), Bristol Myers Squibb's anti-PD-1 immunotherapy.
  • There are currently no National Comprehensive Cancer Network® (NCCN) Category 1 recommended agents for patients with advanced RCC who were previously treated with prior immunotherapy.
  • The randomized, controlled, open-label TiNivo-2 Phase 3 study enrolled patients with RCC who have progressed following prior immunotherapy treatment.

Black Diamond Therapeutics Announces Initial Dose Escalation Data Demonstrating Anti-Tumor Activity of BDTX-1535 in Non-Small Cell Lung Cancer Patients Across Multiple EGFR Mutation Families

Retrieved on: 
Tuesday, June 27, 2023
Diamond, PK, DNA, Radiation, Central nervous system, PRS, GBM, Diarrhea, Half-life, Progression-free survival, RECIST, Pharmacokinetics, Black Diamond, Mutation, TKI, Toxicity, Appetite, Lung cancer, Paronychia, CNS, Associate, Glioblastoma, Rash, M26 Modular Accessory Shotgun System, Patient, Stomatitis, EGFR, Memorial Sloan Kettering Cancer Center, Cancer, Webcast, Nausea, Neoplasm, FDA, Therapy, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, ORR, Food, Metastasis, Safety, Fatigue, Disease, Medical imaging, Pharmaceutical industry, NSCLC

BDTX-1535 is an investigational fourth-generation epidermal growth factor receptor (EGFR) MasterKey inhibitor being developed for the treatment of non-small cell lung cancer (NSCLC) and glioblastoma multiforme (GBM).

Key Points: 
  • BDTX-1535 is an investigational fourth-generation epidermal growth factor receptor (EGFR) MasterKey inhibitor being developed for the treatment of non-small cell lung cancer (NSCLC) and glioblastoma multiforme (GBM).
  • The new data from the dose escalation portion of the Phase 1 study demonstrated clinical proof of activity of BDTX-1535 in NSCLC patients harboring both acquired resistance and intrinsic driver EGFR mutations.
  • “These initial safety and clinical activity data support the continued development of BDTX-1535 as a potential first and best-in-class treatment option for osimertinib-resistant NSCLC patients.
  • ET to discuss the initial results from the Phase 1 dose escalation study of BDTX-1535 in patients with NSCLC.

Kexing Biopharm Obtains the Products of Trastuzumab and Neratinib Maleate Tablets

Retrieved on: 
Monday, June 26, 2023
Therapy, Marketing, Biotechnology, Biopharmaceutical, Tablet, TKI, Synthetic biology, Patient, Injection, R, Breast cancer, Fine chemical, Bevacizumab, Kingdom Holding Company, Trastuzumab

Meanwhile, Kexing has also signed with Convalife Pharmaceuticals a cooperation agreement for the international commercialization of Neratinib Maleate Tablets.

Key Points: 
  • Meanwhile, Kexing has also signed with Convalife Pharmaceuticals a cooperation agreement for the international commercialization of Neratinib Maleate Tablets.
  • Kexing Biopharm has obtained the rights to commercialize Convalife Pharmaceuticals' Neratinib Maleate Tablets in six countries, including Indonesia, Thailand, Vietnam, the Philippines, Malaysia, and Egypt.
  • These agreements not only further expand the pipeline of Kexing Biopharm's antitumor products, but also showcase its strength in overseas commercialization.
  • With a product portfolio strategy focused on breast cancer, Kexing Biopharm has already secured important products like albumin-bound paclitaxel, trastuzumab, bevacizumab, and neratinib.

Live from ASCO 2023 | Ascentage Pharma Releases Updated Data Showing APG-2449's Potential as a New Treatment for Drug-Resistant NSCLC

Retrieved on: 
Tuesday, June 6, 2023
PRS, PD, Diarrhea, Cohort, American Society of Clinical Oncology, DCR, Cancer, Trae tha Truth, Pharmacokinetics, Sun, TKI, CHB, NSCLC, Lung cancer, Sun Yat-sen University Cancer Center, Female, ASCO, Vomiting, ORR, Drug resistance, Patient, Annual general meeting, Nausea, ALT, FAK, Poster, Principal, Notifiable disease, AST, Society, Landing slot, SD, Hepatitis, PR, Safety, ALK, Pharmaceutical industry

Among these results, the updated clinical data of APG-2449 showed the potential as a new treatment option that can effectively overcome drug resistance through the targeted inhibition of FAK.

Key Points: 
  • Among these results, the updated clinical data of APG-2449 showed the potential as a new treatment option that can effectively overcome drug resistance through the targeted inhibition of FAK.
  • Developed by Ascentage Pharma, APG-2449 is an orally available, small-molecule FAK/ALK/ROS1 TKI and the first China-developed third-generation ALK inhibitor entering clinical development.
  • "We believe that FAK inhibition could be a new treatment strategy for patients with NSCLC resistant to second-generation ALK inhibitors."
  • Appendix: The four posters on Ascentage Pharma's four lead drug candidates, including APG-2449, presented at this year's ASCO Annual Meeting.