Takeda receives approval for fruzaqla in Japan for the treatment of unresectable advanced or recurrent colorectal cancer
- Takeda has received approval from the Japanese Ministry of Health, Labour and Welfare to market FRUZAQLA (fruquintinib) for advanced or recurrent colorectal cancer.
- The approval is based on the FRESCO-2 trial, a global Phase 3 study that showed significant benefits in overall survival and progression-free survival.
- FRUZAQLA demonstrated a manageable safety profile, with adverse events leading to discontinuation being similar between the treatment and placebo groups.
- FRUZAQLA is now approved in the U.S., European Union, Japan, and several other countries, with plans to expand availability further.
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Junshi Biosciences announces European Commission approval for marketing of toripalimab
- The European Commission (EC) has approved toripalimab for two indications: recurrent/metastatic nasopharyngeal carcinoma (NPC) and unresectable advanced/recurrent/metastatic esophageal squamous cell carcinoma (ESCC).
- Approval is based on positive results from the JUPITER-02 and JUPITER-06 Phase III clinical studies, showing significant survival benefits.
- Toripalimab is now the first and only drug approved in Europe for NPC and the only first-line treatment for advanced/metastatic ESCC, regardless of PD-L1 status.
- This approval applies to all 27 EU member states, Iceland, Norway, and Liechtenstein.
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Silexion Therapeutics announces significant new data from Phase 2 trial of LODER in non-resectable pancreatic cancer
- Phase 2 trial of LODER in non-resectable locally advanced pancreatic cancer (LAPC) shows a 56% objective response rate (ORR).
- ORR increases to 67% in patients whose previously non-resectable tumors became resectable.
- LODER combined with standard-of-care chemotherapy improves overall survival by 9.3 months compared to chemotherapy alone.
- Silexion is developing SIL-204, targeting a broader range of KRAS mutations with improved stability and efficacy.
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Amarex achieves orphan drug designation for Gibson Oncology’s novel LMP744 cancer treatment
- Amarex secured Orphan Drug Designation (ODD) from the FDA for Gibson Oncology's LMP744, targeting gliomas.
- LMP744 crosses the blood-brain barrier at 10 times the concentration needed to kill cancer cells, maintaining high levels for over 24 hours.
- The drug inhibits two cancer targets: TOPO 1 and cMyc oncogene, showing promise in treating gliomas.
- LMP744 and LMP400 are set to enter Phase 2 clinical trials for recurrent gliomas in collaboration with the NIH.
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