Consumer Health: Treating liver cancer
October is Liver Cancer Awareness Month, which makes this a good time to learn more about treating liver cancer. More than 41,000 new cases of primary liver cancer and intrahepatic bile duct cancer will be diagnosed in the U.S. this year, and more than 30,000 people will die of these diseases, according to the American Cancer Society. Liver cancer is cancer that begins in the cells of your liver, which is a football-sized organ in the upper right portion… (Source: News from Mayo Clinic)
Source: News from Mayo Clinic - October 27, 2022 Category: Databases & Libraries Source Type: news

Latest Mesothelioma T-Cell Clinical Trial Moves to Phase II
The most recent T-cell therapy aimed at mesothelioma cancer has advanced to phase II of the clinical trial process, with researchers exploring its effectiveness when combined with an already approved immunotherapy duet. Investigators are studying the synergistic effect of gavocabtagene autoleucel (gavo-cel) when used with the combination of Opdivo and Yervoy, which was approved by the U.S. Food and Drug Administration in 2020 to treat mesothelioma. Its earlier phase I results, when used alone, were impressive – 93% of patients experienced tumor regression – raising hopes for a much-needed advancement in mesotheli...
Source: Asbestos and Mesothelioma News - October 17, 2022 Category: Environmental Health Authors: Lynette Zilio Source Type: news

Orphan Drug Designation Given to New Mesothelioma CAR T-Cell Therapy
In early 2023, the world-class Hospital of the University of Pennsylvania will open a groundbreaking clinical trial for mesothelioma patients utilizing a next-generation immunotherapy with a novel delivery platform. The U.S. Food and Drug Administration cleared the path in September by granting orphan drug designation for SynKIR-110, a CAR T-cell therapy designed to target solid tumors expressing a specific protein typically found in mesothelioma cancer. By granting the orphan drug designation, the FDA can provide financial incentives such as tax credits for clinical trials and seven years of market exclusivity. It i...
Source: Asbestos and Mesothelioma News - October 5, 2022 Category: Environmental Health Authors: Fran Mannino Source Type: news

FDA Approves Futibatinib for Certain Biliary Tract Cancers FDA Approves Futibatinib for Certain Biliary Tract Cancers
The indication is for use in adult patients with previously treated intrahepatic cholangiocarcinoma harboring fibroblast growth factor receptor 2 (FGFR2) gene fusions or other rearrangements.FDA Approvals (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - October 3, 2022 Category: Consumer Health News Tags: Hematology-Oncology News Alert Source Type: news

FGFR2 Inhibitor Nabs Speedy Approval for Cholangiocarcinoma
(MedPage Today) -- The FDA granted accelerated approval to futibatinib (Lytgobi) tablets for treating adults with intrahepatic cholangiocarcinomas that harbor fibroblast growth factor receptor 2 (FGFR2) gene fusions or other rearrangements. Futibatinib... (Source: MedPage Today Public Health)
Source: MedPage Today Public Health - October 3, 2022 Category: American Health Source Type: news

FDA Approves Lytgobi (futibatinib) for Previously Treated, Unresectable, Locally Advanced or Metastatic Intrahepatic Cholangiocarcinoma
Lytgobi (pronounced“light-GOH-bee”) delivered an objective response rate of 42% and median duration of response of 9.7 months in the primary analysis of the pivotal clinical trial. Lytgobi covalently binds to FGFR2 and inhibits the... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - September 30, 2022 Category: Drugs & Pharmacology Source Type: news

FDA grants accelerated approval to futibatinib for cholangiocarcinoma
On September 30, 2022, the Food and Drug Administration granted accelerated approval to futibatinib (Lytgobi, Taiho Oncology, Inc.) for adult patients. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - September 30, 2022 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Incyte Announces FDA Approval of Pemazyre (pemigatinib) as the First and Only Targeted Treatment for Myeloid/Lymphoid Neoplasms (MLNs) with FGFR1 Rearrangement
This marks the second indication for Pemazyre, which received accelerated FDA approval in 2020 for adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2)... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - August 26, 2022 Category: Drugs & Pharmacology Source Type: news

Verismo Therapeutics Announces Submission of IND Application to the FDA for SynKIR-110TM, a KIR-CAR T-cell Immunotherapy Candidate
Company advances towards in-human clinical trials for SynKIRTM platform targeting Mesothelin-Expressing Advanced Ovarian Cancer, Cholangiocarcinoma, and Mesothelioma PHILADELPHIA, Aug. 19, 2022 -- (Healthcare Sales & Marketing Network) -- Verismo Thera... Biopharmaceuticals, Oncology Verismo Therapeutics, KIR-CAR, CAR T-cell therapy (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - August 19, 2022 Category: Pharmaceuticals Source Type: news

Janssen Presents Initial Results from the Phase 2 RAGNAR Study of BALVERSA ® (erdafitinib) in Patients with Advanced Solid Tumors with FGFR Alterations
CHICAGO, ILLINOIS, June 7, 2022 – The Janssen Pharmaceutical Companies of Johnson & Johnson today announced initial results from the pivotal Phase 2 RAGNAR study evaluating the investigational use of BALVERSA® (erdafitinib), a fibroblast growth factor receptor (FGFR) kinase inhibitor, in patients with advanced solid tumors with prespecified FGFR alterations. At a planned interim analysis (IA), responses were observed across a variety of FGFR-driven solid tumors for patients who had exhausted standard treatment options prior to being treated with BALVERSA®.[1] These results will be featured in an oral presentation (...
Source: Johnson and Johnson - June 7, 2022 Category: Pharmaceuticals Tags: Innovation Source Type: news

HAIP Chemotherapy or Resection for Multifocal Bile Duct Cancer?
(MedPage Today) -- Hepatic arterial infusion pump (HAIP) floxuridine chemotherapy may represent an effective alternative to curative-intent resection in patients with multifocal intrahepatic cholangiocarcinoma who are at risk for surgical complications... (Source: MedPage Today Surgery)
Source: MedPage Today Surgery - May 11, 2022 Category: Surgery Source Type: news

U.S. Food and Drug Administration (FDA) Accepts for Priority Review Taiho Oncology ’s New Drug Application for Futibatinib for Cholangiocarcinoma
PRINCETON, N.J., MARCH 30, 2022– Taiho Oncology, Inc. and Taiho Pharmaceutical Co., Ltd. announced today that the U.S. Food and Drug Administration (FDA) has accepted for priority review the New Drug Application (NDA) for futibatinib in the... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - March 30, 2022 Category: Drugs & Pharmacology Source Type: news

KRAS-Variant Subtypes Tied to Worse Outcomes in Intrahepatic Bile Duct Cancer KRAS-Variant Subtypes Tied to Worse Outcomes in Intrahepatic Bile Duct Cancer
In patients with intrahepatic cholangiocarcinoma who underwent curative resection, G12 KRAS variants, were associated with worse survival and increased risk of recurrence in a Chinese cohort study.Reuters Health Information (Source: Medscape Gastroenterology Headlines)
Source: Medscape Gastroenterology Headlines - November 19, 2021 Category: Gastroenterology Tags: Hematology-Oncology News Source Type: news

Consumer Health: What do you know about liver cancer?
October is Liver Cancer Awareness Month, which makes this a good time to learn more about liver cancer. More than 42,000 new cases of primary liver cancer and intrahepatic bile duct cancer will be diagnosed in the U.S. this year, and more than 30,000 people will die of these diseases, according to the American Cancer Society. Liver cancer is cancer that begins in the cells of your liver, which is a football-sized organ in the upper… (Source: News from Mayo Clinic)
Source: News from Mayo Clinic - October 7, 2021 Category: Databases & Libraries Source Type: news

Pharma built on Shire's old cancer business gets new FDA approval
Servier Pharmaceuticals, the Boston-based subsidiary of the French Servier Group that was built around Shire plc ’s cancer business, has scored an approval from the U.S. Food and Drug Administration for a cancer drug and a related diagnostic test. The FDA on Wednesday gave the go-ahead to a drug called Tibsovo, which is currently only used to treat a specific type of acute myeloid leukemia, to be used in a mutation-specific metastatic cholangiocarcinoma, a rare but aggressive cancer that attacks… (Source: bizjournals.com Health Care:Pharmaceuticals headlines)
Source: bizjournals.com Health Care:Pharmaceuticals headlines - August 26, 2021 Category: Pharmaceuticals Authors: Rowan Walrath Source Type: news