LadRx Corporation, a biopharmaceutical company specializing in cancer therapeutics, has announced its plans to seek marketing approval for aldoxorubicin under the FDA's Section 505(b)(2). This pathway is designed for new drug compositions with an active ingredient already approved by the FDA, which in this case is doxorubicin, the active component of aldoxorubicin. This approach allows LadRx to leverage the existing non-clinical and clinical data of doxorubicin to demonstrate the efficacy and safety of aldoxorubicin, significantly reducing the regulatory burden.
Aldoxorubicin has been granted orphan designation for certain rare diseases, which, along with the 505(b)(2) pathway, could provide market exclusivity upon approval. The company had previously initiated the 505(b)(2) process for aldoxorubicin in 2017 for the treatment of soft tissue sarcoma but was halted due to a licensing agreement with Nantcell, Inc. Following the termination of this agreement in June 2024, LadRx has regained control of aldoxorubicin and restarted the 505(b)(2) process.
LadRx anticipates that the process will include some bridging studies in animals to connect the data between doxorubicin and aldoxorubicin but does not expect to conduct additional human clinical studies. The company plans to request a pre-NDA meeting with the FDA in mid-2025 to confirm the requirements discussed prior to the out-licensing of aldoxorubicin in 2017. The completion of NDA-related activities and subsequent marketing application and approval are contingent upon FDA agreement and securing additional funding, neither of which can be guaranteed at this time.
