FDA grants fast track designation to paxalisib for glioblastoma
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The FDA granted fast track designation to paxalisib for the treatment of patients with newly diagnosed glioblastoma, according to a manufacturer-issued press release.
This designation applies to the use of paxalisib (GDC-0084, Kazia Therapeutics Ltd.), a small molecular inhibitor of the PI3K/AKT/mTOR pathway, for patients with unmethylated MGMT promotor status who completed initial radiation treatment with concomitant temozolomide.
Interim data from a phase 2 study of patients with newly diagnosed glioblastoma, presented in June at American Association for Cancer Research Virtual Annual Meeting II, showed median OS of 17.7 months with paxalisib, which represents an improvement over the historical 12.7-month median OS associated with temozolomide, according to the release.
“In awarding fast track designation to paxalisib, FDA has recognized the drug’s potential to meaningfully improve outcomes for patients with glioblastoma. This is a very powerful acknowledgement,” James Garner, MBBS, CEO of Kazia, said in the release.
Paxalisib also has been selected to join the international GBM AGILE pivotal study, which uses an adaptive clinical trial platform for glioblastoma.
The agent received orphan drug designation for this indication in 2018, and rare pediatric disease designation earlier this month for the treatment of children with diffuse intrinsic pontine glioma.
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