There is a public review being conducted starting today by FDA’s Oncologic Drugs Advisory Committee (ODAC) of six separate indications granted under the agency’s accelerated approval process that later failed to meet key endpoints in confirmatory clinical studies. The hearings involve 2 specific indications for atezolizumab (Tecentriq), 3 for pembrolizumab (Keytruda), and 1 for nivolumab (Opdivo), and based on the testimony, ODAC will consider whether the approvals should be withdrawn and/or whether additional trials should be conducted. Accelerated approval pathways have been important in oncology drug development, with oncology indications accounting for 85% of drugs approved through this pathway. It will be interesting to see how these hearings begin to shape future accelerated approvals, as many of these approvals have also provided significant benefits to critically ill patients.
Interesting article about a CRISPR-based lineage tracing technique that can be used to predict the behavior of cancer cells and identification of tumor spreading patterns associated with disease progression. By identifying genes that contribute to this metastatic activity, more selective and targeted therapies can be developed to inhibit the spread of disease.
Exciting news in the treatment of glioblastoma! Improved survival, calculated at 17.7 months, compared to 12.7 months for standard of care. FDA has granted Fast Track Designation to paxalisib (formerly GDC-0084) from Australian-based Kazia Therapeutics Limited for the treatment of glioblastoma, the most common and aggressive form of primary brain cancer.