FDA grants fast track designation to several oncology therapies
Click Here to Manage Email Alerts
The FDA granted fast track designation to several oncology and hematology therapies.
The designations apply to agents in development for treatment of bladder cancer, breast cancer, glioblastoma and myelodysplastic syndrome.
The agents are:
• Belzupacap sarotalocan (AU-011; Aura Biosciences Inc.) for treatment of non-muscle invasive bladder cancer.
Belzupacap sarotalocan consists of a virus-like particle conjugated with an anticancer agent. A phase 1 trial is expected to begin later this year.
• OP-1250 (Olema Oncology) for treatment of ER-positive, HER2-negative metastatic breast cancer.
OP-1250 is an oral complete estrogen receptor antagonist and selective ER degrader.
A phase 1/phase 2 trial is underway to investigate the agent as single-agent therapy for recurrent, locally advanced or metastatic ER-positive, HER2-negative breast cancer. A phase 1B trial is evaluating the agent in combination with palbociclib (Ibrance, Pfizer).
• VAL-083 (Kintara Therapeutics) for newly diagnosed unmethylated glioblastoma.
VAL-083 is a small-molecule chemotherapeutic with a novel mechanism of action that has demonstrated activity against central nervous system, ovarian and other solid tumors, according to a Kintara Therapeutics-issued press release.
A registrational phase 2/phase 3 trial is evaluating the agent as treatment of glioblastoma.
• Sitoiganap (ERC Belgium SA) for treatment of glioblastoma.
A randomized phase 2 trial is underway to assess sitoiganap — a cell-based immunotherapy — as part of combination treatment for recurrent glioblastoma or gliosarcoma.
• Eltanexor (Karyopharm Therapeutics) for treatment of myelodysplastic syndrome.
Eltanexor is an oral selective inhibitor of nuclear export investigational compound.
A phase 1/phase 2 study is underway to evaluate the agent for treatment of relapsed or refractory myelodysplastic syndrome.
References:
- Aura Biosciences receives FDA fast track designation for belzupacap sarotalocan (AU-011) for the treatment of non-muscle invasive bladder cancer (press release). Available at: https://ir.aurabiosciences.com/news-releases/news-release-details/aura-biosciences-receives-fda-fast-track-designation-belzupacap. Published June 30, 2022. Accessed Aug. 8, 2022.
- ERC granted FDA fast track designation for sitoiganap in patients with recurrent glioblastoma (press release). Available at: https://www.erc-immunotherapy.com/media/news/erc-granted-fda-fast-track-designation-sitoiganap-patients-recurrent-glioblastoma. Published July 26, 2022. Accessed Aug. 8, 2022.
- Karyopharm granted regulatory designations for eltanexor for the treatment of myelodysplastic syndromes (press release). Available at: https://investors.karyopharm.com/2022-07-20-Karyopharm-Granted-Regulatory-Designations-for-Eltanexor-for-the-Treatment-of-Myelodysplastic-Syndromes. Published July 20, 2022. Accessed Aug. 8, 2022.
- Kintara Therapeutics granted fast track designation from the FDA for VAL-083 for newly-diagnosed glioblastoma (press release). Available at: https://www.kintara.com/news-media/press-releases/detail/998/kintara-therapeutics-granted-fast-track-designation-from. Published June 15, 2022. Accessed Aug. 8, 2022.
- Olema Oncology receives FDA fast track designation for OP-1250 for the treatment of ER+/HER2- metastatic breast cancer (press release). Available at: https://ir.olema.com/news-releases/news-release-details/olema-oncology-receives-fda-fast-track-designation-op-1250. Published July 21, 2022. Accessed Aug. 8, 2022.
Collapse
Press Release
Click Here to Manage Email Alerts