NEW YORK – Innovent this week said that pemigatinib (Pemazyre) was approved in Hong Kong as a treatment for locally advanced or metastatic cholangiocarcinoma with an FGFR2 fusion or rearrangement. The approval was based on the Phase II FIGHT-202 study, which showed a 37 percent response rate for cholangiocarcinoma patients treated with pemigatinib. Innovent licensed the drug from Incyte in 2018 for development and commercialization in greater China. It was approved in this indication in Taiwan in June 2021 and has been accepted for review by China's National Medical Products Administration.
Senhwa Biosciences said this week that the US Food and Drug Administration granted fast track designation to pidnarulex for the treatment of patients with breast and ovarian cancers that harbor BRCA1/2, PALB2, or other HRD mutations. Senhwa is studying pidnarulex in a Phase Ib trial in solid tumors, including breast, ovarian, pancreatic, and prostate cancers, that have BRCA1/2, PALB2, or HRD mutations.
Oric Pharmaceuticals said this week that its clinical trial application was cleared by regulators in Korea, allowing the company to begin a Phase I trial of ORIC-114 in patients with advanced solid tumors with EGFR or HER2 exon 20 alterations, or with HER2 amplifications. The company, based in South San Francisco, California, expects to begin the trial in the coming months. Oric anticipates reporting initial data from the study in the first half of 2023. The company licensed ORIC-114 from Korean drug discovery firm Voronoi for $13 million in 2020.
The FDA this week granted breakthrough therapy designation to Dizal Pharmaceutical's DZD9008 for patients with previously treated, advanced non-small cell lung cancer harboring EGFR exon20 insertions. DZD9008, or sunvozertinib, has demonstrated encouraging antitumor efficacy in this patient population during Phase I/II clinical trials, including among patients with brain metastases and patients previously treated with amivantamab (Janssen's Rybrevant). Shanghai-based Dizal is currently evaluating the agent in Phase II clinical trials in China, the US, the EU, Japan, Australia, and South Korea, among other regions.
The FDA this week granted orphan drug designation to Nanjing Bioheng Biotech's autologous CAR T-cell therapy CTB001 for gastric cancer patients. The therapy is designed to target claudin 18.2, which is commonly overexpressed on gastric, pancreatic, ovarian, lung, and bile duct tumors. According to Bioheng, CTB001 has shown "excellent efficacy and safety" in exploratory clinical studies.
In Brief This Week is a selection of news items that may be of interest to our readers but had not previously appeared in Precision Oncology News.