Gamma-glutamyltransferase

HUTCHMED Announces Savolitinib sNDA Accepted in China for Treatment-Naïve or Previously Treated Patients with Locally Advanced or Metastatic MET Exon 14 NSCLC

Retrieved on:

Thursday, March 28, 2024

HONG KONG and SHANGHAI, China and FLORHAM PARK, N.J., March 27, 2024 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM:HCM; HKEX:13) today announces that the supplemental New Drug Application (“sNDA”) for savolitinib, in adult patients with locally advanced or metastatic non-small cell lung cancer (“NSCLC”) with mesenchymal epithelial transition factor (“MET”) exon 14 skipping alteration, has been accepted for review by the China National Medical Products Administration (NMPA). If approved, the new label indication for savolitinib will be expanded to include treatment-naïve patients in China.

Key Points:

Savolitinib was previously granted conditional approval in China for the treatment of patients with NSCLC with MET exon 14 skipping alterations who have progressed following prior systemic therapy or are unable to receive chemotherapy.
Savolitinib was launched and is marketed under the brand name ORPATHYS® by our partner, AstraZeneca for this patient population, representing the first selective MET inhibitor approved in China.
More than a third of the world’s lung cancer patients are in China and, among those with NSCLC globally, approximately 2-3% have tumors with MET exon 14 skipping alterations.
The data from this study provide confirmatory evidence for savolitinib as a targeted treatment option for treatment-naïve or previously treated patients with MET exon 14 skipping alteration NSCLC.

ADC Therapeutics Announces Updated LOTIS-2 Results Demonstrating Durable, Long-Term Responses of ZYNLONTA® in Relapsed/Refractory DLBCL

Retrieved on:

Friday, June 9, 2023

LAUSANNE, Switzerland, June 09, 2023 (GLOBE NEWSWIRE) -- ADC Therapeutics SA (NYSE: ADCT) today announced updated results from LOTIS-2, the pivotal Phase 2 clinical trial of ZYNLONTA® (loncastuximab tesirine-lpyl) in patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL).

Key Points:

LAUSANNE, Switzerland, June 09, 2023 (GLOBE NEWSWIRE) -- ADC Therapeutics SA (NYSE: ADCT) today announced updated results from LOTIS-2, the pivotal Phase 2 clinical trial of ZYNLONTA® (loncastuximab tesirine-lpyl) in patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL).
“We’re pleased to be sharing updated LOTIS-2 results demonstrating the long‐term efficacy and safety of ZYNLONTA with the lymphoma community at EHA2023 and 17-ICML,” said Mohamed Zaki, MD, PhD, Chief Medical Officer of ADC Therapeutics.
The median (range) time to response was 41.0 (35 to 247) days for all responders and 42.0 (36 to 247) days for patients with a CR.
All-grade treatment‐emergent adverse events occurring in ≥30% of all patients were increased gamma-glutamyltransferase (42%), neutropenia (40%), and thrombocytopenia (33%).

ADC Therapeutics Announces Validation of its Marketing Authorization Application by the European Medicines Agency for ZYNLONTA®

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Friday, October 29, 2021

Biotechnology, Health, Pharmaceutical, Clinical Trials, Oncology, Safety, B-cell lymphoma, Anemia, Control, Disease, European Medicines Agency, Twitter, PBD, NOS, Nausea, Lymphoid leukemia, Therapy, Neutropenia, Doctor of Philosophy, Enzyme, Rash, Diffuse large B-cell lymphoma, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, View, Advanced Therapy Medicinal Product, Food, Induced cell cycle arrest, DNA repair, Lymphoma, European Commission, Hyperglycemia, Company, Genetics, MAA, DLBCL, ADC, EMA, Marketing Authorisation Application, Marketing, NYSE, Lymphatic system, ORR, Distortion, Thrombocytopenia, Royal commission, Fatigue, Orphan, Patient, DNA, Technology, LinkedIn, Cancer, Hodgkin lymphoma, Edema, FDA, CHMP, Adult, Gamma-glutamyltransferase, Lists of diseases, Vaccine, Pharmaceutical industry, ZYNLONTA®, ADC Therapeutics, ZYNLONTA®, ADC THERAPEUTICS

Validation of the application enables the evaluation process by the EMAs Committee for Medicinal Products for Human Use (CHMP) to begin.

Key Points:

Validation of the application enables the evaluation process by the EMAs Committee for Medicinal Products for Human Use (CHMP) to begin.
This is a significant step forward in our commitment to making ZYNLONTA available to as many patients as may benefit.
In September 2021, the European Commission granted Orphan Drug Designation to ZYNLONTA for the treatment of DLBCL.
In addition to ZYNLONTA and Cami, ADC Therapeutics has multiple ADCs in ongoing clinical and preclinical development.

Karallief's KaraLiv™ Dietary Ingredient Promotes Healthy Liver Function in 30 Days, A New Clinical Study Finds

Retrieved on:

Monday, October 18, 2021

Published in the International Journal of Basic & Clinical Pharmacology, this double-blind, parallel, placebo-controlled, randomized clinical trial found that KaraLiv safely, quickly and effectively supports liver function.

Key Points:

Published in the International Journal of Basic & Clinical Pharmacology, this double-blind, parallel, placebo-controlled, randomized clinical trial found that KaraLiv safely, quickly and effectively supports liver function.
However, Karallief has a strong commitment to conducting clinical studies and scientific research for all their herbal extract ingredient formulas.
"A healthy liver is essential for a good quality of life, because it maintains healthy blood sugar levels and creates critical nutrients the body needs.
And yet there have not been many supplements with herbal ingredients that have gone through such rigorous clinical trials until now."

ADC Therapeutics Receives Orphan Drug Designation in Europe for ZYNLONTA®

Retrieved on:

Monday, September 13, 2021

Biotechnology, Health, Science, Research, Oncology, European Union, Lists of diseases, DLBCL, Hyperglycemia, Food, Therapy, COMP, Patient, FDA, Neutropenia, Technology, Induced cell cycle arrest, Orphan, Control, Hodgkin lymphoma, Marketing, Union, Company, European Commission, EMA, DNA repair, Genetics, View, LinkedIn, Royal commission, Disease, NYSE, Diffuse large B-cell lymphoma, Adult, Safety, Fatigue, DNA, ORR, Nausea, Enzyme, MD, Lymphoma, ADC, Senior, Lymphatic system, Twitter, NOS, Thrombocytopenia, Gamma-glutamyltransferase, Anemia, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Rash, PBD, Lymphoid leukemia, Cancer, B-cell lymphoma, Distortion, Edema, Fine chemical, Pharmaceutical industry, ZYNLONTA® (loncastuximab tesirine-lpyl), ADC Therapeutics, ZYNLONTA® (LONCASTUXIMAB TESIRINE-LPYL), ADC THERAPEUTICS

ADC Therapeutics SA (NYSE: ADCT), a commercial-stage biotechnology company leading the development of novel antibody drug conjugates (ADCs) to treat hematological malignancies and solid tumors, today announced that the European Commission has granted Orphan Drug Designation to ZYNLONTA, a CD19-targeted ADC, for the treatment of diffuse large B-cell lymphoma (DLBCL).

Key Points:

ADC Therapeutics SA (NYSE: ADCT), a commercial-stage biotechnology company leading the development of novel antibody drug conjugates (ADCs) to treat hematological malignancies and solid tumors, today announced that the European Commission has granted Orphan Drug Designation to ZYNLONTA, a CD19-targeted ADC, for the treatment of diffuse large B-cell lymphoma (DLBCL).
This Orphan Drug Designation recognizes the significant unmet need in patients with diffuse large B-cell lymphoma in the European Union (EU), said Joseph Camardo, MD, Senior Vice President and Chief Medical Officer of ADC Therapeutics.
Orphan Drug Designation in the EU is granted by the European Commission based on a positive opinion issued by the EMA Committee for Orphan Medicinal Products (COMP).
ADC Therapeutics (NYSE: ADCT) is a commercial-stage biotechnology company improving the lives of cancer patients with its next-generation, targeted antibody drug conjugates (ADCs).