FDA approves ivosidenib for advanced or metastatic cholangiocarcinoma

… with previously treated, locally advanced or metastatic cholangiocarcinoma with an isocitrate dehydrogenase-1 (IDH1) … diagnostic device to aid in selecting patients with cholangiocarcinoma for treatment with ivosidenib. Ivosidenib … of 185 adult patients with locally advanced or metastatic cholangiocarcinoma with an IDH1 mutation. The patient’s …

FDA Approves First Targeted Treatment for Patients with Cholangiocarcinoma, a Cancer of Bile Ducts

… adults with certain types of previously treated, advanced cholangiocarcinoma. “This approval demonstrates that while we … options following first line treatment with chemotherapy.” Cholangiocarcinoma is a rare form of cancer that forms in … and small intestine. Today’s approval is for patients with cholangiocarcinoma that is locally advanced (when cancer has …

FDA D.I.S.C.O. Burst Edition: FDA approval of Tibsovo (ivosidenib) for adult patients with previously treated, locally advanced or metastatic cholangiocarcinoma with an isocitrate dehydrogenase-1 mutation as detected by an FDA-approved test

… with previously treated, locally advanced or metastatic cholangiocarcinoma with an isocitrate dehydrogenase-1 … diagnostic device to aid in selecting patients with cholangiocarcinoma for treatment with ivosidenib. Ivosidenib … of 185 adult patients with locally advanced or metastatic cholangiocarcinoma with an isocitrate dehydrogenase-1 …

FDA D.I.S.C.O. Burst Edition: FDA approval of Lytgobi (futibatinib) for adult patients with previously treated, unresectable, locally advanced or metastatic intrahepatic cholangiocarcinoma harboring fibroblast growth factor receptor 2 gene fusions or other rearrangements

… unresectable, locally advanced or metastatic intrahepatic cholangiocarcinoma harboring fibroblast growth factor … unresectable, locally advanced, or metastatic intrahepatic cholangiocarcinoma harboring a fibroblast growth factor … unresectable, locally advanced or metastatic intrahepatic cholangiocarcinoma harboring fibroblast growth factor …

FDA D.I.S.C.O. Burst Edition: FDA approvals of Lumakras (sotorasib) for patients with KRAS G12C mutated locally advanced or metastatic non-small cell lung cancer, and Truseltiq (infigratinib) for unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 fusion or other rearrangement

… treated, unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 … treated, unresectable locally advanced or metastatic cholangiocarcinoma with a fibro-blast growth factor receptor … Truseltiq for unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 …

WITHDRAWN: FDA grants accelerated approval to infigratinib for metastatic cholangiocarcinoma

… treated, unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 … for the required confirmatory clinical trial in first line cholangiocarcinoma (a new indication under investigation for … result, continued distribution of TRUSELTIQ in second line cholangiocarcinoma (the accelerated approval indication) was …

FDA grants accelerated approval to futibatinib for cholangiocarcinoma

… unresectable, locally advanced or metastatic intrahepatic cholangiocarcinoma harboring fibroblast growth factor … unresectable, locally advanced, or metastatic intrahepatic cholangiocarcinoma harboring a FGFR2 gene fusion or other … Drugs … FDA grants accelerated approval to futibatinib for cholangiocarcinoma …

FDA grants accelerated approval to pemigatinib for cholangiocarcinoma with an FGFR2 rearrangement or fusion

… treated, unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 … patients with locally advanced unresectable or metastatic cholangiocarcinoma whose disease had progressed on or after … Drugs … FDA grants accelerated approval to pemigatinib for cholangiocarcinoma with an FGFR2 rearrangement or fusion …

Drug Trials Snapshot: LYTGOBI

… of adults with a type of bile duct cancer (intrahepatic cholangiocarcinoma) that has spread to other parts of the … patients with intrahepatic bile duct cancer (intrahepatic cholangiocarcinoma) who had been previously treated with … locally advanced unresectable or metastatic intrahepatic cholangiocarcinoma whose disease had progressed on or after …

Drug Trials Snapshot: PEMAZYRE

… a drug used for treatment of adults with bile duct cancer (cholangiocarcinoma) that has spread to other parts of the … to have locally advanced unresectable or metastatic cholangiocarcinoma whose disease had progressed on or after … a drug used for treatment of adults with bile duct cancer (cholangiocarcinoma) that has spread to other parts of the …

FDA D.I.S.C.O. Burst Edition: FDA approval of Imfinzi (durvalumab) for adult patients with locally advanced or metastatic biliary tract cancer

… were 65 years or older. Fifty-six percent had intrahepatic cholangiocarcinoma, 25% had gallbladder cancer, and 19% had extrahepatic cholangiocarcinoma. The major efficacy outcome measure was …

FDA approves durvalumab for locally advanced or metastatic biliary tract cancer

… were 65 years or older. Fifty-six percent had intrahepatic cholangiocarcinoma, 25% had gallbladder cancer, and 19% had extrahepatic cholangiocarcinoma. Patients were randomized 1:1 to receive: …

Oncology Regulatory Review

… (Truseltiq and Tibsovo) for adults with certain kinds of cholangiocarcinoma, a group of aggressive cancers that start … in areas of unmet need such as for the treatment of cholangiocarcinoma and to detect KRAS G12C variants in … mutations Y/N 11. 5/28/2021 Truseltiq (infigratinib 1, 2 ) cholangiocarcinoma Y/Y 12. 5/28/2021 Lumakras (sotorasib 1, 2 …

Drug Trials Snapshots: TRUSELTIQ

… of adults with previously treated bile duct cancer (cholangiocarcinoma) that is advanced, unresectable (cannot be … trial (NCT02150967) of 108 patients with bile duct cancer (cholangiocarcinoma). The trials were conducted at 18 sites in … to have locally advanced unresectable or metastatic cholangiocarcinoma whose disease had progressed on or after …

Oncology Regulatory Review

… melanoma, prostate cancer, hepatocellular carcinoma, and cholangiocarcinoma. These included 11 approvals of new drugs … unresectable, locally advanced or metastatic intrahepatic cholangiocarcinoma harboring fibroblast growth factor … N 9/30/2022 Lytgobi (futibatinib) 1, 3 FGFR2 intrahepatic cholangiocarcinoma 74 Y Y 10/25/2022 Tecvayli (teclistamab) …

Ongoing | Cancer Accelerated Approvals

… unresectable, locally advanced or metastatic intrahepatic cholangiocarcinoma harboring fibroblast growth factor … of futibatinib in patients with advanced or metastatic cholangiocarcinoma harboring an FGFR2 gene fusion or other … treated, unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 …

FoundationOne CDx (F1CDx) – P170019/S048

… lung cancer, melanoma, breast cancer, colorectal cancer, cholangiocarcinoma, prostate cancer, ovarian cancer, and …

Oncomine™ Dx Target Test – P160045/S025

… samples from people with non-small cell lung cancer , cholangiocarcinoma (bile duct cancer), thyroid cancer , and …

Oncomine Dx Target Test – P160045/S031

… samples from patients with non-small cell lung cancer and cholangiocarcinoma, or bile duct cancer. This test detects …

FoundationOne CDx – P170019/S014

… breast cancer, colorectal cancer, bile duct cancer (cholangiocarcinoma), prostate cancer, ovarian cancer, and …

Oncomine™ Dx Target Test – P160045/S035

… from patients with non-small cell lung cancer (NSCLC) and cholangiocarcinoma. The test detects changes to the DNA …

FDA approves selpercatinib for locally advanced or metastatic RET fusion-positive solid tumors

… bronchial carcinoid, ovarian, small intestine, and cholangiocarcinoma. The median age of patients was 50 years …

Oncology Therapeutic and Diagnostic Devices

… in areas of unmet need such as for the treatment of cholangiocarcinoma and to detect KRAS G12C variants in …

Oncology (Cancer)/Hematologic Malignancies Approval Notifications

… FDA grants accelerated approval to futibatinib for cholangiocarcinoma On September 30, 2022, the Food and Drug … unresectable, locally advanced or metastatic intrahepatic cholangiocarcinoma harboring fibroblast growth factor … FDA approves ivosidenib for advanced or metastatic cholangiocarcinoma Food and Drug Administration approved …

FDA D.I.S.C.O. Burst Edition: FDA approvals of Retevmo (selpercatinib) for adult patients with locally advanced or metastatic RET fusion-positive solid tumors, and Retevmo (selpercatinib) for adult patients with locally advanced or metastatic RET fusion-positive non-small cell lung cancer

… bronchial carcinoid, ovarian, small intestine, and cholangiocarcinoma. The median age of patients was 50 years, …