FDA grants Fast Track Designation for Sapanisertib in NRF2-mutated Squamous Lung Cancer
“While there have been significant advances in targeted treatments for lung cancer, little progress has been made specifically for patients with squamous lung cancer. In addition, we know that patients with lung cancers that harbor mutations in the NRF2/KEAP1 pathway typically have poorer outcomes than those whose tumors do not have these mutations,” said Susan Molineaux, chief executive officer of Calithera. “This Fast Track designation allows for a variety of benefits, including the possibility of priority review of sapanisertib as we seek to provide a first-in-class treatment option that may help address the major unmet need in this patient population.”
Share:
More News
Thomas Guérinier, CEO and Co-founder of Inside Therapeutics: “The collaboration with OSE and MiNT provides us with a fantastic opportunity to demonstrate the uniqueness of our technology for the development of mRNA therapies from early development through to clinical trials and GMP production. The HexARN project fits perfectly with our
Thomas Mehrling, MD, PhD, CEO and Director of Helix, said “As co-founder of the Laevoroc companies, I’ve had the privilege of seeing LEUMUNA and GEMCEDA evolve from early scientific concepts into differentiated, first-in-class therapeutic candidates with real potential to transform cancer care. Their integration into Helix marks a strategic consolidation
“At Boundless, we’re committed to delivering innovative therapies for patients with oncogene-amplified cancers through disciplined execution,” said Zachary Hornby, President and Chief Executive Officer of Boundless Bio. “By prioritizing the novel combination of BBI-355 and BBI-825, along with our exciting Kinesin program, BBI-940, we’re concentrating our resources where we see
