ResQ117EX-ALC: Expanded Access Use of Nogapendekin-alfa Inbakicept in the Reversal and Maintenance of Absolute Lymphocyte Count (ALC) for the Treatment of Lymphopenia Induced by Chemotherapy, Immunotherapy, and/or Radiation Therapy
Latest Information Update: 16 Oct 2025
At a glance
- Drugs Nogapendekin alfa inbakicept (Primary)
- Indications Lymphopenia
- Focus Expanded access; Therapeutic Use
- Sponsors ImmunityBio
Most Recent Events
- 25 Jul 2025 According to ImmunityBio media release, the Company has met with the Division of Non-Malignant Hematology at the FDA in June to present updated data from its lymphopenia program. The Division was supportive of the findings and supports an efficient path to approval, noting that additional time will be required to finalize the development plan.
- 25 Jul 2025 According to ImmunityBio media release, FDA is supportive of new data and has reaffirmed RMAT/EAP.
- 12 May 2025 According to ImmunityBio media release, the company has submitted an EAP protocol for ANKTIVA for the treatment of lymphopenia.