Paxalisib

In December 2024, FDA approved several treatments including zenocutuzumab for NRG1+ NSCLC and pancreatic cancer, cosibelimab for CSCC, and combinations for BRAF V600E+ mCRC. Fast track and breakthrough designations were granted for treatments in MDS, cervical cancer, NSCLC, and SCLC. Priority reviews were given for taletrectinib in ROS1+ NSCLC and remestemcel-L for pediatric acute GVHD.

FDA considers paxalisib's OS data for GBM suitable for standard, not accelerated, approval. Kazia and FDA agreed on a phase 3 study design. Paxalisib showed a 3.8-month OS improvement in GBM-AGILE trial, with median OS of 15.54 months vs. 11.89 months for SOC in newly diagnosed GBM.

Kazia Therapeutics updated on paxalisib's glioblastoma treatment following FDA discussions. The FDA noted OS data from the GBM-AGILE study supports a standard, not accelerated, approval and aids in designing a pivotal phase 3 study, with agreement on study design aspects.

Kazia Therapeutics updated on paxalisib's regulatory pathway for glioblastoma treatment after a Type C FDA meeting. FDA suggested OS data supports standard, not accelerated, approval. Kazia plans a pivotal Phase 3 study, aligning with FDA on design. Paxalisib also shows promise in pediatric brain cancer and breast cancer treatments.

Kazia Therapeutics provided a regulatory update on paxalisib for glioblastoma treatment after a Type C meeting with the FDA. The FDA suggested OS data supports standard approval, not accelerated. Kazia plans a pivotal Phase 3 study, aligning with FDA on design aspects. Paxalisib also shows promise in pediatric brain cancer and breast cancer treatments.

Kazia Therapeutics updated on paxalisib's regulatory pathway post-FDA meeting, indicating OS data from GBM-AGILE study aids traditional approval. Aligned phase 3 study design marks progress for glioblastoma treatment. Paxalisib also tested in other cancers, with strategic path forward by January 2025.

Kazia Therapeutics' stock dropped 26% after the FDA indicated it could consider standard, not accelerated, approval for its brain cancer drug, paxalisib. Despite showing survival improvement in trials, the FDA's stance led to a significant stock decline.