Game-changing cancer therapy: Imugene’s VAXINIA receives FDA orphan drug status for bile tract cancer

Game-changing cancer therapy: Imugene’s VAXINIA receives FDA orphan drug status for bile tract cancer

Imugene Limited has received a significant boost with the United States Food and Drug Administration (FDA) granting Orphan Drug Designation (ODD) to its experimental therapy, CF33-hNIS (VAXINIA), aimed at treating bile tract cancer. This designation propels Imugene’s clinical-stage oncolytic virotherapy forward, positioning the Sydney-based company as a key player in the development of innovative cancer […]

TCR2 Therapeutics reports positive interim results for gavo-cel in early-stage solid tumors trial

TCR2 Therapeutics reports positive interim results for gavo-cel in early-stage solid tumors trial

TCR2 Therapeutics has reported positive interim results from its phase 1 part of the phase 1/2 clinical trial of its T-cell therapy candidate gavo-cel in mesothelin-expressing solid tumors. The US-based clinical-stage cell therapy company said that as of the 30 June 2021 data cutoff, 17 patients, which include 12 mesothelioma, four ovarian cancer and one […]

Incyte bags Pemazyre FDA approval for cholangiocarcinoma treatment

Incyte bags Pemazyre FDA approval for cholangiocarcinoma treatment

Pemazyre FDA approval : US biopharma company Incyte has bagged accelerated approval from the US Food and Drug Administration (FDA) for Pemazyre (pemigatinib) for the treatment of cholangiocarcinoma, a rare type of cancer occurring in the bile ducts. The approval is for adult patients having certain types of previously treated, advanced cholangiocarcinoma. According to the […]

Incyte secures FDA priority review for pemigatinib in cholangiocarcinoma

Incyte secures FDA priority review for pemigatinib in cholangiocarcinoma

Delaware-based pharma company Incyte has secured priority review for pemigatinib from the US Food and Drug Administration (FDA) for the treatment of locally advanced or metastatic cholangiocarcinoma. The priority review for pemigatinib is for the treatment of the condition in previously treated patients having FGFR2 fusions or rearrangements. Cholangiocarcinoma is a rare cancer that occurs […]